Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Digestive System Diseases

Rare Diseases

Prostatic Neoplasms

Kidney Diseases

Leiomyoma

Prolapse

Myofibroma

Endometriosis

Uterine Prolapse

Cholecystitis

Acalculous Cholecystitis

Intestinal Obstruction

Renal Insufficiency, Chronic

Renal Insufficiency

Genital Diseases

Urogenital Diseases

Male Urogenital Diseases

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Chronic Disease

Disease Attributes

Genital Diseases, Female

Pathological Conditions, Anatomical

Gallbladder Diseases

Biliary Tract Diseases

Gastrointestinal Diseases

Intestinal Diseases

Uterine Diseases

Pelvic Organ Prolapse

Chronic Graft Versus Host Disease

All Drugs and Chemicals

Central Nervous System Depressants

Other Dietary Supplements

Rocuronium

Benzocaine

Neuromuscular Nondepolarizing Agents

Neuromuscular Blocking Agents

Tannic Acid

This group will undergo deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion of the surgery followed by a period of moderate blockade.

This group will undergo moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery followed by a period of deep blockade.

Rocuronium infusion will be paused and the Train of Four (TOF) monitor will be set to every 1-2 min. Once the patient has achieved a "moderate" NMB state (one to two twitches), the infusion of the muscle relaxant will be resumed at a low dose to maintain the patient at this level of blockade.

Deep to Moderate NMB

Rocuronium infusion will be increased in increments of 0.1-0.2 mg/kg/hr. and the TOF monitor will be set to every 1-2 min. Once the patient has no twitches and a PTC of 0-1 ("deep" NMB) the infusion will be adjusted to maintain the patient at this level of NMB.

Moderate to Deep NMB

Ruchir Gupta, MD

This is a two period cross-over study randomizing patients undergoing laparoscopic surgery into 2 different groups: group 1 in which patients receive "deep neuromuscular blockade" in the beginning portion of their laparoscopic surgery followed by a period of "moderate blockade" and, group 2 in which patients receive "moderate neuromuscular blockade" in the beginning portion of their laparoscopic surgery followed by a period of "deep blockade". The deep neuromuscular block is defined as post tetanic count of 1 to 2 and the moderate neuromuscular block is defined as 1-2 twitches. In all patients, sugammadex is used to reverse the block at the end of surgery in order to obtain optimal extubating conditions.

Neuromuscular blockade (NMB) is frequently utilized in laparoscopic procedures to improve surgical conditions by relaxing the abdominal muscles and thus facilitating insufflation with carbon dioxide to optimize surgical view. Increased airway pressures can lead to an increase in alveolar and perivascular edema, a decline in dynamic lung compliance and hypoxemia.

Several studies have investigated surgical view under deep vs. moderate neuromuscular blockade. Literature supports deep neuromuscular blockade providing better operating conditions/view by a surgeon and low airway pressures but, potentially, longer duration to extubation and worse respiratory mechanics at the end of anesthesia versus moderate neuromuscular blockade which shows worse operating conditions/view by a surgeon and worse airway pressures but possibly shorter duration to extubation and better respiratory mechanics at the end of anesthesia.

Thus, there is clearly equipoise with regard to the comparative effectiveness of deep vs medium NMB. Therefore, this study is designed to ascertain if a deep neuromuscular block will decrease the airway pressures in patients undergoing laparoscopic procedures compared to those under a moderate block. A reduction in airway pressures may lead to a decrease in the complications associated with elevated airway pressures including hypoxemia, total static lung compliance, alveolar edema, and long term morbidity. Additionally, the study aims to determine if time from administration of sugammadex to reversal is different between patients that have a moderate NMB as compared to a deep NMB.

Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery

Effect of Deep Versus Moderate Neuromuscular Blockade on Peak Airway Pressures During Elective Laparoscopic Surgery

Fully analyzed results may be shared with Merck Investigator Studies Program personnel after the study has completed

To determine if a deep NMB can lead to lower peak airway pressures in patients undergoing laparoscopic procedures when compared to a moderate NMB

To compare surgical operating condition by Abdominal Insufflation Pressure in patients undergoing laparoscopic procedures using deep NMB versus moderate NMB

To compare surgical operating condition by Surgical Rating Scale (SRS) in patients undergoing laparoscopic procedures using deep NMB versus moderate NMB

Surgical Rating Score scores are on a 1-5 scale with 1 = extremely poor conditions, 2 = poor conditions, 3 = adequate conditions, 4 = good conditions, 5= excellent conditions. Higher scores mean a better outcome.

Merck Sharp & Dohme LLC

Stony Brook University

Clinical Assistant Professor

This group will underwent neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion or during the second portion of the surgery

Deep NMB

This group underwent moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery or during the second portion of the surgery

Moderate NMB

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Procedure

Dr. Ruchir Gupta

Mean

Maximum

This group underwent deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion of the surgery or during the second portion of the surgery

This group underwent moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery or during the second period of the surgery

Peak Airway Pressures

This group underwent deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion or during the second portion of the surgery

Abdominal Insufflation Pressure

ModerateNMB

Surgical Rating Scale

This group will undergo deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion of the surgery followed by a period of moderate blockade.

Rocuronium

Deep to Moderate Neuromuscular Block (NMB)

This group will undergo moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery followed by a period of deep blockade.

Rocuronium

Period 1

Period 2

Gallbladder Neoplasms

Gallstones

Cholelithiasis

Cholecystolithiasis

Incidental gallbladder cancer and other pathology

Histopathological result

Ufuk Uylas

Causes such as long-term stones and polyp are thought to play a role in the etiology of gallbladder cancer. The routine histopathological examination provides the detection of incidental gallbladder cancers. It should be remembered that acute or chronic cholecystitis accompanied by the thicked wall and a prolonged history of gallstones may be the cause of malignancy, especially in elderly patients.

The investigators aimed to incidental gallbladder cancer and compare other pathology results with elderly patients.

Incidental Cancer in Gallbladder Surgical Specimens Focus on Elderly Patients

Incidental Cancer in Gallbladder Surgical Specimens Focus on Elderly Patients, Retrospective Analysis of 2389 Patients

Number of Participants with adenocarcinom

Dr. Ersin Arslan Education and Training Hospital

Specialist

Wounds and Injuries

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Calculi

Gallbladder Cancer

Ropivacaine

Anesthetics

Anesthetics, Local

Local ropivacaine infiltration + laparoscopically controlled TAP (transversus abdominis plane block). Daycare patients.

Local ropivacaine infiltration only. Daycare patients.

Local ropivacaine infiltration + laparoscopically controlled TAP. In-patient surgery.

Local ropivacaine infiltration only. In-patient surgery.

Local ropivacaine infiltration + laparoscopically controlled TAP. Emergency patients.

Local ropivacaine infiltration only. Emergency patients.

single transversus abdominis laparoscopy-guided plane block

local trocar site ropivacaine infiltration

Roman Kornõšev, MD

Alexey Schramko, MD, PhD, Doc

Roman Kornõšev

Alexey Schramko, PhD, Doc

Henna Sammalkorpi, MD, PhD

Hanna Lampela, MD, PhD

Jukka Harju, MD, PhD, Doc

This trial is a prospective randomized superiority trial comparing sole ropivacaine based local trocar site infiltration to local infiltration combined with laparoscopic ropivacaine TAP block (STALL) in LCC.

There are only a few randomized trials comparing sole local anesthesia to additional laparoscopic TAP block in laparoscopic cholecystectomy and they have yet failed to show evidence in favor of TAP block.

We hypothesize STALL (Single Transversus Abdominis Laparoscopy-guided plane block combined with Local trocar site ropivacaine infiltration) is superior to local port site infiltration, provided that the sample size is sufficiently big.

The aim of this randomized study is to compare the efficacy of sole local anesthesia of trocar sites to STALL in LCC.

Patients are analyzed following the intention to treat in three subgroups:

1. Patients treated in "day-care" outpatient surgical unit (DS): TAP+local vs local.
2. Patients treated electively in the inpatient surgery unit (IS): TAP+local vs local.
3. Emergency surgery patients (ES): TAP+local vs local.

The study will be blinded to patients and recovery room personnel, as well as the ward nurses and physicians, but not to operating surgeon(s), anesthesiologist(s), and nurses, treating patients during the surgery.

STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy

Single Transversus Abdominis Laparoscopy-guided Plane Block Combined With Local Trocar Site Ropivacaine Infiltration (STALL) vs Sole Local Wound Infiltration in LCC (Laparoscopic CholeCystectomy) - Double-blinded Randomized Controlled Trial.

min, (= "patient ready to be discharged" timestamp OR "patient ready for transfer")

TAP + port site infiltration complications (as per trial plan) + other complications according to Clavien-Dindo classification

using questionnaires, multiple timepoints: recovery stay, hospital stay, discharge, feedback after 7 days

APS (acute pain service) contact, admission of DS subgroup patient to the ward due to pain, failure to discharge

Helsinki University Central Hospital

Carcinoma

Neoplasm Metastasis

Carcinoma, Hepatocellular

Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.

Prior to surgery these patients will be given the ICG standard dose of 2.5 mg IV.

Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).

Indocyanine green

The PINPOINT Endoscopic Fluorescence Imaging System (Stryker Corporation, Kalamazoo, Michigan) will be used. This device enables the surgeon to simultaneously see real-time, high-definition visible-range and NIR fluorescence videos and to superimpose them. It is currently approved by the FDA for intraoperative near-infrared fluorescence imaging.

PINPOINT Endoscopic Fluorescence

Ali Zarrinpar, MD, PhD

Near-infrared fluorescence (NIRF) imaging after an intravenous injection of indocyanine green (ICG) allows for the intraoperative identification of liver anatomy. The investigators have new data that a much lower dose improves this visualization. Confirmation of this hypothesis would mean that ICG can be administered on the same day of surgery in order to augment real-time intraoperative visualization, thereby providing a safe, feasible, and cost-effective strategy for the surgical treatment of liver disease.

The investigators have a series of surgical cases in which the investigators have been able to achieve excellent intraoperative biliary visualization with a greatly decreased (50-200 fold lower) dose of ICG than the previously published dose. Furthermore, this decreased dose was visible in about 15-20 minutes from the time of injection with low liver background fluorescence, a significant improvement that would make its utilization in the operating room more practical. The investigators hypothesize that a lower dose will: 1) allow adequate visualization of the extrahepatic biliary tree, including the cystic, common hepatic, and common bile ducts. Confirmation of hypotheses would mean that a lower dose of ICG can be administered on the same day of surgery in order to augment real-time intraoperative localization of the extrahepatic biliary tree, thereby providing a safe, feasible, and cost-effective strategy for the surgical treatment of liver disease.

The investigators intend to test our hypothesis with the following specific aims:

Aim 1: To compare the efficacy and utility of a low dose ICG (0.05 mg) protocol with a previously published dose (2.5 mg) in imaging the extrahepatic biliary tract.

Adult patients scheduled to undergo a laparoscopic hepatic or biliary operation will be randomized to two groups 1) low dose (0.05 mg) or 2) standard dose (2.5 mg) of ICG preoperatively on the day of surgery. Patients with a history of adverse reactions or known allergy to ICG, iodine, or iodine dyes will be excluded.

To mask the investigator randomization will be done with envelopes for this study and the dose given to the patient prior to surgery with the investigator not being aware of the amount given.

Low Dose ICG for Biliary Tract and Tumor Imaging

Low Dose ICG for Near-infrared Fluorescence Imaging of Biliary Tract and Tumors

We are not sharing individual participant data with other researchers

Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the liver

A qualitative assessment will be made based on the quality of the intraoperative visualization of the extrahepatic biliary tree on a scale of 1 to 5 (1 = no improvement/identification not confirmed; 2 = marginally improved; 3 = sufficiently improved; 4 = well improved; 5 = greatly improved/exceeds expectations).

Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the background fat

Society of University Surgeons

University of Florida

ICG is a very safe drug with minimal risk for adverse advents. Participants were given a very low dose

Study participants who received low dose ICG.

Low Dose

Study participants who received standard dose ICG.

Standard Dose

Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.

Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).

Prior to surgery these patients will be given a ICG dose of 2.5 mg IV.

Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).

Age, Categorical

White

Black

Asian

Race/Ethnicity, Customized

United States

Region of Enrollment

5 enrolled and randomized patients were excluded from analysis because their videos were either too dark or unusable due to technical issues with the scope, camera, or device tower.

Dr. Ali Zarrinpar

Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio

Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree - NIRFC Versus White Light

Prior to surgery these patients will be given a ICG dose of 2.5 mg IV.

Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety)

Quantitative Assessment - Bile Duct-to-background Fat Fluorescence Intensity Ratio

Common Hepatic Duct

Cystic Duct

Common Bile Duct

Aberrant Duct

Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree (Common Hepatic Duct, Cystic Duct, Common Bile Duct, Aberrant Ducts)

Prior to surgery these patients will be given a ICG dose of 0.05 mg IV.

Indocyanine green: Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).

PINPOINT Endoscopic Fluorescence: The PINPOINT Endoscopic Fluorescence Imaging System (Stryker Corporation, Kalamazoo, Michigan) will be used. This device enables the surgeon to simultaneously see real-time, high-definition visible-range and NIR fluorescence videos and to superimpose them. It is currently approved by the FDA for intraoperative near-infrared fluorescence imaging.

Overall Study

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.

The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.

Glidescope guided intubation

GlideScope®

The GlideScope® videolaryngoscope usually visualize glottis better than the conventional laryngoscope. Under the visualization of glottis by GlideScope®, the insertion of endotracheal tube, however, is challenging.

The goal of this study was to determine which of two stylet (70° vs 90°) was better, as determined by time to intubation.

Effect of Modified Stylet Angulation on the Intubation With GlideScope®

Stylet Angulation of Seventy Degrees Reduced Time to Intubation With the GlideScope®: A Prospective Randomized Trial

Time from the insertion of the Glidescope blade to the measurement of end tidal CO2 (\>30 mmHg)

The number of patients in which the intubation was successful at the first time.

Difficulty of intubation will be measured using visual analogue scale (0:easiest, 100:most difficult).

External laryngeal manipulation is defined as the compression of neck for the facilitation of laryngeal view. Number of participants for whom external laryngeal manipulation was necessary will be measured.

The grade of Cormack-Lehan was assessed as I/II/III/IV (I: Full view of glottis, II: Partial view of glottis, III: Only epiglottis seen, none of glottis seen, IV: Neither glottis nor epiglottis seen). Grade I was considered better outcomes.

The Mallapati grade was assessed as I/II/III/IV (I: Soft palate, uvula, fauces, pillars visible, II: Soft palate, uvula, fauces visible, III: Soft palate, base of uvula visible, IV: Only hard palate visible). Grade I was considered better outcomes.

Postoperative sore throat will be measured using visual analogue scale (0:no pain, 100: worst pain imaginable)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery	NCT02812186	Cholecystitis Endometriosis Bowel Obstructi... Fibroids Prostate Cancer Chronic Kidney ... Uterine Prolaps...	Deep to Moderat... Moderate to Dee... Rocuronium	18 Years -	Stony Brook University
Incidental Cancer in Gallbladder Surgical Specimens Focus on Elderly Patients	NCT04352478	Pathology	Histopathologic...	-	Dr. Ersin Arslan Education and Training Hospital
STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy	NCT06123117	Cholelithiasis Cholecystitis Gallbladder Can...	single transver... local trocar si...	18 Years -	Helsinki University Central Hospital
STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy	NCT06123117	Cholelithiasis Cholecystitis Gallbladder Can...	single transver... local trocar si...	18 Years -	Helsinki University Central Hospital
Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery	NCT02812186	Cholecystitis Endometriosis Bowel Obstructi... Fibroids Prostate Cancer Chronic Kidney ... Uterine Prolaps...	Deep to Moderat... Moderate to Dee... Rocuronium	18 Years -	Stony Brook University
Low Dose ICG for Biliary Tract and Tumor Imaging	NCT04942665	Cholecystitis Hepatocellular ... Liver Metastase...	Indocyanine gre... PINPOINT Endosc...	18 Years - 80 Years	University of Florida
Effect of Modified Stylet Angulation on the Intubation With GlideScope®	NCT02547064	Cholecystitis Stomach Cancer	Glidescope guid... GlideScope®	18 Years - 80 Years	Keimyung University Dongsan Medical Center
ONSD According to the Position During Laparoscopy	NCT01937104	Cholecystitis Ovarian Cyst Ovarian Cancer Uterine Myoma Cervical Cancer	Desflurane Remifentanil Ultrasonographi... Mechanical vent... Trendelenburg p... Reverse Trendel...	19 Years - 65 Years	Chosun University Hospital
Incentive Spirometry and Upper Abdominal Laparoscopic Surgery	NCT04716166	Cholecystitis Perforated Duod... Diaphragmatic H... Benign Pancreas... Malignant Pancr... Splenic Infarct... Splenomegaly Choledocholithi... Hiatal Hernia	Volume-oriented... Flow-oriented i...	25 Years - 65 Years	Riphah International University
ONSD According to the Position During Laparoscopy	NCT01937104	Cholecystitis Ovarian Cyst Ovarian Cancer Uterine Myoma Cervical Cancer	Desflurane Remifentanil Ultrasonographi... Mechanical vent... Trendelenburg p... Reverse Trendel...	19 Years - 65 Years	Chosun University Hospital

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