Neoplasms

Musculoskeletal Diseases

All Conditions

Skull Base Neoplasms

Skull Neoplasms

Bone Neoplasms

Bone Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Procedure: Endotracheal tube

Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:

* baseline, in the operating room before anesthetic induction (non invasive arterial pressure)
* end of surgery, before awakening (ETT group) or before ETT replacement (LMA group)
* at 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group assignment).

Procedure: Laryngeal mask

Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:

* baseline, in the operating room before anesthetic induction (non invasive arterial pressure)
* end of surgery, before awakening (ETT group) or before ETT replacement (LMA group)
* at 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group assignment).

In the Endotracheal group In the ETT group, the procedure will be exactly the same except that the ETT will not be exchanged and the patient will be directly extubated

Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:

* baseline, in the operating room before anesthetic induction (non invasive arterial pressure)
* end of surgery, before awakening (ETT group) or before ETT replacement (LMA group)
* at 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group assignment).

endotracheal tube

In the LMA group, after aspirating pharyngeal secretions and with the patient still under general anesthesia, we will insert a Proseal LMA (Laryngeal Mask Co. Ltd., Le Rocher, Victoria, Mahe Seychelles) and extubate the trachea using a guided Bailey technique

Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:

* baseline, in the operating room before anesthetic induction (non invasive arterial pressure)
* end of surgery, before awakening (ETT group) or before ETT replacement (LMA group)
* at 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group assignment).

Laryngeal mask

Paola Hurtado, MD

The endoscopic endonasal transsphenoidal surgery (EETS) is widely used. Although the incidence of complications is low, hypertensive episodes during surgery and awakening and cerebro spinal fluid (CSF) leakage have been described. The occurrence of coughing or vomiting during the early postoperative period must be avoid to protect the patient from CSF leakage and arterial hypertension. The emergency of anesthesia with laryngeal mask has a better haemodynamic profile and less incidence of cough in some surgical procedures and it could help minimizing the risks after EETS

Randomization

At the end of surgery, the anesthesiologist will open a sealed envelope labeled with software-generated randomized numbers to assign the patients, who will be allocated in a 1:1 ratio from nonstratified blocks of four patients, to one of two groups to emerge from anesthesia with the ETT still in place (ETT group) or after it has been replaced by a LMA (LMA group).

Study procedure

In the LMA group, after aspirating pharyngeal secretions and with the patient still under general anesthesia, the investigators will insert a Proseal LMA (Laryngeal Mask Co. Ltd., Le Rocher, Victoria, Mahe Seychelles) and extubate the trachea using a guided Bailey technique. Specifically, the LMA will be inserted after first advancing a suction catheter along the drain tube 8-10 cm beyond the distal end; the mask will be then inserted using a digital technique behind the orotracheal tube, allowing the suction catheter to enter the esophagus first and guiding the tip of the cuff. A number 4 or 5 mask will be chosen for patients weighing 50-70 kg or 70-100 kg, respectively. The cuff will be inflated to a pressure of 60 cmH2O measured with a manometer. Then the orotracheal tube balloon will be deflated and the tube removed. Ventilation then will be continued with the same parameters as had been used earlier.

Administration of neuromuscular relaxants will be then stopped so the patient could emerge from anesthesia. Once the patient recover 2/4 responses of the TOF, neostigmine (0.03 mg/Kg) and atropine (0.01mg/kg) will be given to reverse the neuromuscular blockade and Target-controlled infusion of anesthetics will be stopped. Lidocaine will not be administrated.

Gentle manual ventilator assistance will be then provided until the patient resume spontaneous breathing and respond to simple commands; the LMA or the ETT, depending on the group, will be then removed.

The investigators will administer prophylaxis of nausea in the postoperative period with ondansetron 4 mg/8h/iv.

In the ETT group, the procedure will be exactly the same except that the ETT will not be exchanged and the patient will be directly extubated when the patient will fulfill the same criteria.

Parameters

Patient variables (age, weight, height, sex) and relevant aspects of past medical history, such as:

* controlled hypertension
* tobacco addiction
* respiratory disease will be also registered, including sleep apnea and any chronic respiratory disease (chronic bronquitis, emphysema, chronic pulmonary obstructive disease).
* cough test

Diagnosis, type of surgery, the placement of lumbar drainage.

Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:

* baseline, in the operating room before anesthetic induction (non invasive arterial pressure)
* end of surgery, before awakening (ETT group) or before ETT replacement (LMA group)
* at 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group assignment).

The last blood pressure and HR measurements will be taken in the postoperative recovery room. Respiratory variables (including end-tidal carbon dioxide concentration) will be controlled during MV.

* Neurosurgeon will rate the amount of blood in the surgical field (1: no blood; 2: small bleeding that does not interfere with surgery; 3: bleeding that interferes with surgery but surgery is possible; 4: bleeding that impedes normal development of surgery).
* Any coughing episode during the first 5 minutes of awakening. Considering light coughing (1 cough) and strong coughing (access of cough).
* Preoperative xylometazoline administration.
* Intraoperative hypertension and antihypertensive agent administered.
* Endotracheal tube size and laryngeal mask size.
* Difficulties in LMA ventilation.
* Postoperative nausea or vomiting
* CSF leakage during the admission and in the first month.
* Postoperative bleeding.

The objective of the investigators study is evaluate the incidence of coughing and hypertension during awakening in patients after EETS comparing the effect of laryngeal mask vs orotracheal tube.

Effects on the Awakening With Laryngeal Mask vs Endotracheal Tube in Endoscopic Endonasal Transsphenoidal Base Surgery

Changes in systolic blood pressure comparing two methods lma vs ett

Compare noradrenaline levels in both groups

Fundacion Clinic per a la Recerca Biomédica

MD, PhD

Symptoms and General Pathology

Neovascularization, Pathologic

Metaplasia

ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery and tumor dissection: before intradural dissection and during tumor dissection.

Using the near-infrared light nasal endoscope with ICG will identify anatomical landmarks and and tumor characteristics to provide a clear demonstration of the blood supply.

near-infrared light nasal endoscope used with ICG

Daniel Prevedello, MD

This study is being done to demonstrate the feasibility of using a nasal endoscope to perform intraoperative angiography of surgical field, with the goals to evaluate anatomical landmarks and tumor characteristics during skull base surgery and publish a technical note.

Proposal for Intraoperative Administration of Intravenous Indocyanine Green to Evaluate Position of the Optic Canal, Position of the Internal Carotid Arteries, Tumor Vascularization, and Vessel Encasement in Endoscopic Endonasal Cranial Base Surgery

We aim to show that ICG fluorescence of the tumor intraoperatively is directly proportional to the contrast enhancement of the tumor from preoperative MRI. Enhancement is shown in ratio form on a scale of 0.01-1.00 showing enhancement ratios of 1. gland to internal carotid artery compared to blood fluorescence and 2. tumor tissue to blood fluorescence. Video recordings of intra-operative ICG fluorescence was compared to pre-operative imaging enhancements and compared in ratio format with a possible score of 0.01-1.00 The higher the ratio, the more closely the intra-operative fluorescence was related to the pre-operative imaging enhancements. 1.00 is considered to have the same enhancing brightness on pre-operative imaging as intra-operative video surveillance.

Ohio State University

Associate Professor

Adverse events were only recorded if the event was related to the study procedure. Events that occur due to the standard of care surgery were not recorded.

ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery and tumor dissection: before intradural dissection and during tumor dissection.

near-infrared light nasal endoscope used with ICG: Using the near-infrared light nasal endoscope with ICG will identify anatomical landmarks and and tumor characteristics to provide a clear demonstration of the blood supply.

Near-infrared Light Nasal Endoscope Used With ICG

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Daniel Prevedello, MD

gland to internal carotid artery ratio

tumor to internal carotid artery ratio

Patients undergoing tumor resection via endoscopic endonasal approach. Tumor pathologies included: pituitary adenoma (10), chordoma (4), tuberculum sellae meningioma (3), chondrosarcoma (1) estesioneuroblastoma (1) and Rathke's cleft cyst (1)

ICG Fluorescence Ratio

Overall Study

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Osteomyelitis

Paranasal Sinus Diseases

Nose Neoplasms

Communicable Diseases

Bone Diseases, Infectious

Nose Diseases

Respiratory Tract Diseases

Otorhinolaryngologic Diseases

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Respiratory Tract Neoplasms

Domen Vozel, MD, PhD

Jure Urbančič, MD

This observational prospective clinical study aims to describe the epidemiology, management and outcome of patients with sinonasal and skull-base pathology (tumours and diseases with malignant clinical characteristics) in a tertiary otorhinolaryngology referral centre. The main questions it aims to answer are:

* what is the caseload of patients with the included pathology in our centre
* what are the results of management of these cases
* what are the epidemiological characteristics of included patients
* what is the quality of life of included patients.

Sinonasal tumours and tumours that involve the adjacent skull base are rare entities. However, their management necessitates a special knowledge of ENT areas and specifics of sinonasal anatomy and skull base. Due to the heterogeneity of pathological diagnoses of sinonasal and skull-base tumours, one of the main aims of this study is to provide epidemiological characteristics in our geographical area. Furthermore, to compare with other tertiary referral centres, we will analyse management results, which could improve the management of these diseases. Since the sinonasal area and skull base house several important neuroanatomical structures and senses, we aim to provide an analysis of the patient-reported quality of life.

Prospective Study of Sinonasal and Skull-base Tumours Management

Prospective Observational Study of Sinonasal and Skull-base Tumours Management in a Tertiary Referral Otorhinolaryngology Service

Absence of the disease after the treatment has been completed

Survival after the treatment has been completed

University of Ljubljana, Faculty of Medicine

University Medical Centre Ljubljana

Domen Vozel, MD, PhD, principal investigator

Nervous System Diseases

Hearing Loss

Deafness

Hearing Loss, Sensorineural

Neurilemmoma

Neuroma

Neuroma, Acoustic

Hearing Disorders

Ear Diseases

Sensation Disorders

Neurologic Manifestations

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Vestibulocochlear Nerve Diseases

Retrocochlear Diseases

Cranial Nerve Diseases

Schwannoma

Acoustic Neuroma

Neuroendocrine Tumor

Neuroepithelioma

Patients undergoing a translabyrinthine approach for vestibular schwannoma resection will have the health of their auditory nerve monitored during tumor dissection. If the auditory nerve is visually confirmed to be intact, then concurrent cochlear implantation will be performed.

The Auditory Nerve Test System provides an electrically-evoked signal from within the cochlea to facilitate intraoperative auditory nerve monitoring. The auditory nerve can be measured both at the root entry zone of the brainstem (eCNAP) and with scalp electrodes (eABR). Data on the health of the auditory nerve will be collected immediately prior to tumor dissection, during tumor dissection, and immediately after tumor dissection. The main purpose of this study is to determine feasibility of this novel intraoperative monitoring protocol.

Secondarily, if the auditory nerve is visually confirmed to be intact following tumor resection then the patients will receive a cochlear implant during the same surgery.

Auditory Nerve Test System

Cameron C Wick, MD

The Auditory Nerve Test System (ANTS) is a novel device that stimulates the auditory nerve much like a cochlear implant. The purpose of this study is to demonstrate feasibility of the ANTS during translabyrinthine surgery for vestibular schwannoma resection. If the auditory nerve is kept intact, then the patients will also receive a cochlear implant at the same time potentially alleviating the morbidities caused by a vestibular schwannoma and asymmetric sensorineural hearing loss.

Many patients diagnosed with a vestibular schwannoma (also called acoustic neuroma) eventually lose hearing in the afflicted ear. Improvements in magnetic resonance imaging (MRI) have led to tumors being diagnosed at smaller sizes, however, this has not changed the eventual demise in hearing for most patients. Hearing loss leads to tinnitus, poor sound localization, difficulty hearing in background noise, and imbalance all of which contribute to the decreased quality of life associated with a vestibular schwannoma diagnosis.

Some tumors may be resected while maintaining the integrity of the auditory nerve. When a patient has hearing, the health of the auditory nerve can be monitored during the surgery through auditory-evoked (sound) measurements. When a patient has already lost their hearing or the surgical approach sacrifices all residual hearing, then auditory-evoked measurements can no longer be used and there is no way to monitor the auditory nerve aside from visual inspection.

The Auditory Nerve Test System (ANTS) is a novel device designed to facilitate electrically-evoked auditory nerve monitoring. The ANTS is comprised of three parts: a test electrode, connector cable, and stimulator box. The test electrode functions like a mini-cochlear implant placed within the cochlea during a translabyrinthine surgery. During tumor resection the test electrode electrically stimulates the auditory nerve allowing surgeons to monitor electrophysiologic data on the health of the auditory nerve. The primary goal of this study is to assess the ANTS during translabyrinthine vestibular schwannoma resections.

If patient are able to maintain an intact auditory nerve following vestibular schwannoma resection then a cochlear implant will be placed during the same surgery. Secondary outcomes measures will investigate cochlear implant outcomes and patient quality of life following this procedure and over the first year of using their cochlear implant. These secondary outcomes will be measured at 3-months, 6-months, and 12-months following cochlear implant activation. The test will assess how well the cochlear implant is working, the cochlear implant's impact on sound localization and hearing in background noise, and finally various aspects relevant to the patient's quality of life (tinnitus, balance, hearing, and overall quality of life).

Single arm study of 10 patients with no serviceable hearing due to small or medium sized vestibular schwannomas undergoing translabyrinthine resection.

Auditory Nerve Test System During Vestibular Schwannoma Resection

Feasibility of Auditory Nerve Test System for Optimization of Simultaneous Translabyrinthine Vestibular Schwannoma Resection With Cochlear Implantation

Reliability of electrically-evoked direct auditory nerve monitoring at the brainstem (eCNAP) and far-field auditory brainstem response (eABR). The auditory nerve signal will be monitored before, during, and after vestibular schwannoma resection. Elements like signal amplitude, latency, and preservation of eABR waveforms III and V will be measured.

Speech performance measured in the CI-only condition using CNC Words, AzBio Sentences in Quiet, and AzBio Sentences in +10 dB SNR.

Using an audio booth that contains a sound arc, patients will be asked to identify where a sound is coming from in the implant-on and implant-off conditions. This ability to localize is measured with a root-mean-square (RMS) error rate.

Diagnosis and treatment of vestibular schwannomas can impact multiple aspects of a patient's quality of life. Using patient-reported outcome measures these aspects will be measured throughout their treatment course. The specific questionnaires will be: Speech, Spatial and Qualities of Hearing (SSQ), Hearing Handicap Inventory for Adults (HHIA), Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Penn Acoustic Neuroma Quality of Life (PANQOL), Cochlear Implant Quality of Life (CIQOL).

Washington University School of Medicine

Assistant Professor

ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.

indocyanine green

This is a feasibility study in which indocyanine green (ICG) will be administered during routine expanded endonasal approach (EEA) for cranial base pathologies in which a nasoseptal flap harvest will be necessary. The research entails administering ICG, which is already widely used during open neurosurgical procedures, to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.

This study is being done to determine if it is feasible to use angiography during endo-nasal surgery. During the angiography indocyanine green (ICG) will be injected into the patients IV tubing to help see the arteries. ICG is routinely used in vascular surgeries on the brain but not for endo-nasal surgery. The purpose of this study is to see how well intraoperative angiography using ICG can be done during endonasal surgery.

ICG Use in Angiography for Nasoseptal Flap Harvest

Proposal for Intraoperative Administration of Intravenous Indocyanine Green to Evaluate Sphenopalatine Artery Location and Patency in Harvesting and Positioning a Pedicled Nasoseptal Mucosal Flap in Endoscopic Endonasal Cranial Base Surgery

The researcher will administer ICG, which is already widely used during open neurosurgical procedures, to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case. This study will determine feasibility of other larger clinical trials using this method.

Indocyanine green: ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.

ICG-Angiography With Administered ICG

Age, Continuous

Dr. Daniel Prevedello, Associate Professor

Number of Participants for Which Angiograghy is Used to Visualize Nasoseptal Mucosa Better Than What is Done Standard of Care in This Surgery.

Wounds and Injuries

Hypertrophy

Cerebrospinal Fluid Leak

Pathological Conditions, Anatomical

Craniocerebral Trauma

Trauma, Nervous System

Participant will have PuraGel (RADA16) Hydrogel applied to the nasoseptal flap harvest site following endoscopic skull base surgery

Participant will have a silastic splint (Non-Absorbable Packing) applied to the nasoseptal flap harvest site following endoscopic skull base surgery with no additional packing or agent

Participant will have silastic splint applied to nasoseptal flap harvest site

Non-Absorbable Packing (Silastic Splint)

Participant will have PuraGel (RADA16) Hydrogel applied to the nasoseptal flap harvest site

PuraGel (RADA16) Hydrogel

Satyan Sreenath, MD

The purpose of this study is to specifically evaluate the effectiveness of PuraGel, a RADA16 polypeptide hydrogel, in expediting post-operative healing and re-mucosalization of the nasoseptal flap harvest site during endoscopic skull base surgery and the impact on patient and sinonasal morbidity.

Briefly, multiple agents exist and have been long-studied in endoscopic sinus and septal surgery, which include non-absorbable agents and biodegradable, absorbable synthetic agents including extracellular matrix (ECM) based compounds and synthetic biopolymers. The goal of these agents has often been to reduce sinonasal crusting, postoperative bleeding, and synechia formation. With advancements in postoperative adjuncts, many options now exist for postoperative sinonasal packing including medicated products such as steroid-impregnated stents and chitosan-based absorbable packs.

Lastly, with respect to intra-operative adjuncts designed to foster healing in the postoperative period, PuraGel, a RADA16 polypeptide hydrogel, was identified as an ECM-based solution, which aids in wound healing, adhesion prevention, and hemostasis at the completion of the case. In hydrogel format, this agent forms a synthetic matrix that serves as a scaffold for mucosal healing while serving as a mechanical barrier on tissue surfaces, thereby limiting scarring. To date, there have been no studies evaluating the role of this gel-based compound in the postoperative period in endoscopic skull base surgery.

Thus, amongst all of these agents that have been previously studied to some degree in patients undergoing endoscopic sinus surgery, there has been limited study on their role in endoscopic skull base surgery and utility in reducing sinonasal morbidity in the postoperative setting. Therefore, our goal was to investigate and compare the impact of varying sinonasal agents in the nasal cavity following endoscopic skull base surgery. We hypothesize that the absorbable, ECM-based gel compound (PuraGel) demonstrates an improvement on postoperative healing rate and sinonasal crusting with reduced patient morbidity and improved patient comfort when compared to non-absorbable agents.

This will be double blinded (video endoscopy will be performed and scoring will be performed by non-operative surgeon, blinded to the intervention group).

Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery

Novel Application of RADA16 Hydrogel in Reducing Sinonasal Morbidity After Endoscopic Skull Base Surgery

Modified Lund-Kennedy nasal endoscopy score to rate mucosal edema, nasal crusting, and scarring. This will be double blinded (video endoscopy will be performed and scoring will be performed by non-operative surgeon, blinded to the intervention group). This scoring will address wound healing, adhesion formations. Scoring will be performed at 1 week, 4 weeks, and 12 weeks following surgery. The timing of these assessments is based on the routine postoperative follow-up schedule. No additional appointments will be made for the purposes of this study. We will be looking at the change in this score over time.

Minimum would be 0. Maximum would be 10. Higher score means worse outcome. The un-abbreviated title is Modified Lund-Kennedy nasal endoscopy score.

Patient-reported pain visual analog scale during postoperative debridement of the main nasal cavity. Minimum score is 1 (reflecting no pain) and the maximum score is 10 (reflecting extreme amount of pain).

Minimum would be 0. Maximum would be 10. Higher score means worse outcome. The un-abbreviated title is Patient-reported pain visual analog scale.

Postoperative, subjective QOL score with the validated Anterior Skull Base Nasal Inventory-12 (ASK-12) at 1 week, 4 weeks, and 12 weeks postoperatively.

Minimum would be 0. Maximum would be 72. Higher score means worse outcome. The un-abbreviated title is Anterior Skull Base Nasal Inventory-12.

Likert scale of mucosalization of the nasal septum graded by blinded reviewer via nasal endoscopy video

Minimum would be 0. Maximum would be 10. Higher score means worse outcome. The un-abbreviated title is Likert scale of mucosalization.

3-D Matrix Medical Technology

Indiana University

Assistant Professor, Department of Otolaryngology--Head and Neck Surgery

Sinusitis

Epistaxis

Paranasal Sinus Neoplasms

Respiratory Tract Infections

Hemorrhage

Signs and Symptoms, Respiratory

Chronic Graft Versus Host Disease

Those who are undergoing endoscopic sinonasal surgery for benign and malignant tumor removal.

Those who are receiving Endoscopic Skull Base Surgery (ESBS) for minimally-invasive access for removal of skull base tumors, most commonly for ones of pituitary origin.

Individuals with chronic rhinosinusitis (CRS) with or without polyposis that are to have endoscopic sinus surgery, a minimally invasive procedure to open the sinuses.

Those who have severe nose bleeds and requires going into the operating room for management.

During sinus tumor resection, margins will initially be estimated with the naked eye. Then the dye, Indocyanine Green (ICG), will be injected through the intravenous line to identify tumor margins and be compared to estimated margins.

Sinonasal Benign or Malignant Tumor Resection

In this surgery, a piece of individuals septum will be used for the reconstruction. The amount of time for the flap to fluoresce Indocyanine Green (ICG) will be measured. It will be ensured that the it is still lighting up at the end of the surgery, indicating it is still receiving a good supply and ensures longevity of the flap.

Skull Base Surgery (Assessment of Nasoseptal Flap)

During the surgery, the timing of Indocyanine Green (ICG) administration to fluorescence of anterior and posterior ethmoidal artery and of the internal carotid artery will be measured.

Endoscopic Sinus Surgery

During surgery timing of Indocyanin Green (ICG) administration to fluorescence of the sphenopalatine artery will be measured.

Posterior Epistaxis Management (SPA Ligation)

The endoscope is a device placed into the nasal cavity to remove chronic sinus disease or tumor or create access into the skullbase for extensive tumor removal. Indocyanine Green (ICG) is a dye that is injected through an intravenous site and is used to light up vasculature and margins of a tumor during surgery. This helps avoid damage to important vasculature and obtain clear margins during surgery. This study aims to further assess the utility of ICG when operating within the nasal cavity or skullbase.

The investigators aim to evaluate the effectiveness and feasibility of using a fluorescent dye, Indocyanine Green (ICG), in endoscopic sinus, skullbase, sinus tumor resection, or posterior epistaxis surgery.

Adults 19 years or older, seen in the Principal Investigator and Sub investigator's offices presenting with either CRS, benign or malignant sinonasal, skull base tumors, or posterior epistaxis will be identified by the Principal Investigators and invited to participate in this prospective study. Patients will be recruited into the study in a consecutive manner. After providing consent, baseline characteristics will be collected. The investigators aim to recruit 10 patients in each study group respectively given the patients diagnosis.

Sinus tumor resection - Initially margins will be estimated with the naked eye. Then they will be compared to the margins that are fluorescing with the dye.

Skull base tumor resection - The investigators will use a part of the participant's septum for the reconstruction. The investigators will measure the time it takes for the flap to fluoresce and ensure that it is still lighting up at the end of the surgery. This means that it is still receiving a good supply and ensures longevity of the flap.

Sinus Surgery - During the participant's surgery, the investigator will come across important vessels that will be preserved. The investigator will see if the ICG is able to light up those vessels and if it does, then measure the time it takes to light up will be measured.

Posterior epistaxis - If a participant experiences a nose bleed that requires going into the operating room, the investigator will use ICG to locate the vessel that needs to be cauterized. The investigators will measure the time it takes for that vessel to light up.

The investigator will see the participants back on their day of surgery. During surgery, Indocyanine Green (ICG) will be injected through their intravenous line. The investigator will start with the smallest dose and increase to a dose that allows us to see the structures of interest such as vessels or tumor margins. The time it takes for a vessel or margins of a tumor to light up will be measured. Intra-operative data specific to each type of surgery being performed will be collected.

Dose-Escalation Protocol Intravenous injection

* 1.25mg (0.5mL)
* 2.5mg (1mL)
* 3.75mg (1.5mL)
* 5mg (2mL)
* 6.25mg (2.5mL) \[at discretion of surgeon\]
* 7.5mg (3mL) \[at discretion of surgeon\]

Intralesional injection

* 1.25mg (0.5mL)
* 2.5mg (1mL)
* 3.75mg (1.5mL)
* 5mg (2mL)
* 6.25mg (2.5mL) \[at discretion of surgeon\]
* 7.5mg (3mL) \[at discretion of surgeon\]

Descriptive statistics (count, absolute frequency, and 95% confidence interval) will be used to analyze the baseline characteristic data.

Prospective Case-Series and Feasibility Study

Utility of Indocyanine Green Fluorescence in Endoscopic Sinonasal and Skull Base Surgery

The Utility of Indocyanine Green Fluorescence in Endoscopic Sinonasal and Skull Base Surgery - A Prospective Case-Series and Feasibility Study

During surgery, the amount of time it takes for the area of interest to fluoresce will be recorded.

The total amount of ICG administrated to reach fluorescence of distinct structure will be recorded.

The maximum does/interval of ICG administrated to reach fluorescence of distinct structure will be recorded.

Images of the structure of interests origins and margins will be captured. Images estimated by the surgeon and ICG will be collected.

Any adverse events to ICG that are experienced will be collected.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects on the Awakening With Laryngeal Mask vs Endotracheal Tube in Endoscopic Endonasal Transsphenoidal Base Surgery	NCT02988804	Skull Base Neop...	endotracheal tu... Laryngeal mask	18 Years -	Fundacion Clinic per a la Recerca Biomédica
Proposal for Intraoperative Administration of Intravenous Indocyanine Green to Evaluate Position of the Optic Canal, Position of the Internal Carotid Arteries, Tumor Vascularization, and Vessel Encasement in Endoscopic Endonasal Cranial Base Surgery	NCT03072186	Skull Base Neop... Skull Neoplasms Bone Neoplasm Neoplasms Bone Diseases Musculoskeletal...	near-infrared l...	18 Years -	Ohio State University
Effects on the Awakening With Laryngeal Mask vs Endotracheal Tube in Endoscopic Endonasal Transsphenoidal Base Surgery	NCT02988804	Skull Base Neop...	endotracheal tu... Laryngeal mask	18 Years -	Fundacion Clinic per a la Recerca Biomédica
Proposal for Intraoperative Administration of Intravenous Indocyanine Green to Evaluate Position of the Optic Canal, Position of the Internal Carotid Arteries, Tumor Vascularization, and Vessel Encasement in Endoscopic Endonasal Cranial Base Surgery	NCT03072186	Skull Base Neop... Skull Neoplasms Bone Neoplasm Neoplasms Bone Diseases Musculoskeletal...	near-infrared l...	18 Years -	Ohio State University
Prospective Study of Sinonasal and Skull-base Tumours Management	NCT05607888	Nasal Neoplasm Nasal Neoplasm ... Skull Base Neop... Skull Base Oste... Sinonasal Disor... Sinus Disease		-	University Medical Centre Ljubljana
Auditory Nerve Test System During Vestibular Schwannoma Resection	NCT04241679	Vestibular Schw... Acoustic Neurom... Sensorineural H... Asymmetric Sens... Cochlear Nerve ... Cochlear Nerve ... Skull Base Neop... Auditory; Nerve	Auditory Nerve ...	12 Years -	Washington University School of Medicine
ICG Use in Angiography for Nasoseptal Flap Harvest	NCT02117310	Skull Base Neop...	indocyanine gre...	18 Years -	Ohio State University
Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery	NCT05898074	Skull Base Neop... Cerebrospinal F... Nasal; Hypertro...	Non-Absorbable ... PuraGel (RADA16...	18 Years -	Indiana University
Utility of Indocyanine Green Fluorescence in Endoscopic Sinonasal and Skull Base Surgery	NCT04374448	Chronic Sinusit... Tumor of Nasal ... Posterior Epist... Skull Base Neop...	Sinonasal Benig... Skull Base Surg... Endoscopic Sinu... Posterior Epist...	19 Years -	St. Paul's Sinus Centre

Spots Global Cancer Trial Database for skull base neoplasms