Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Communicable Diseases

Endometrial Neoplasms

Uterine Cervical Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Neoplasms

Uterine Diseases

Uterine Cervical Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Anesthetics

Analgesics, Opioid

Narcotics

Patients who had Major Surgery for gynecologic cancers (cervix, endometrium, ovarian and breast cancer) under balanced anesthesia including opioids between February 2019 and 2020 in Hospital La Paz.

Patients who had Major Surgery for gynecologic cancers (cervix, endometrium, ovarian and breast cancer) under Opioid Free anesthesia between February 2019 and 2020 in Hospital La Paz.

Use of balanced anesthesia including opioids during anesthesia for gynecologic cancer surgery

Opioid

Nicolas Brogly, PhD

Opioid Free Anesthesia (OFA) is a multimodal anesthesia and emerging technique that spares the use of opioids and involve other adjuvant anesthetics, which have demonstrated in vitro influence on immunologic and inflammatory response, as well as in metastatic progression. For these reasons we believe that OFA may positively influence in oncologic patients postoperative recovery and in its disease progression.

After Local Ethics Committee approval, consecutive consenting patients scheduled for major gynecologic oncologic surgery were included between February 2019 and January 2020 in this observational retrospective study. We Compared OFA to standard technique used in our institution and assessed its effect on Postoperative Systemic Inflammatory Response (SIRS), hospital stay, postoperative complications in the following 2 months, cancer progression and mortality 6 months and 12 months after surgery. OFA protocol consisted of a Total IntraVenous Anaesthesia of Propofol, a Dexmedetomidine infusion of 0,8-1,0 mcg/kg/h, together with 0,2-0,3 mg/kg ketamine and lidocaine 1,5 mg/kg in the first hour of surgery. The standard anaesthetic protocol included opioids (Fentanyl 2mcg/kg at induction, and remifentanyl infusion 0,1-0,2 mcg/kg/min) and volatile agents (sevoflurane or desflurane). Patients in both groups received a regional block when possible, dexamethasone 8 mg at induction and paracetamol 1g plus dexketoprofen 50mg at the end of surgery. Continuous variables were compared using unpaired t-test (or Mann-Whitney U test) and categorical variables by Chi-square test. Statistical significance was set at p \< 0.05

patients who Major Surgery for gynecologic cancers (cervix, endometrial, ovarian, vaginal, vulvar and breast cancer)

Opioid Free Anaesthesia in Oncologic Gynaecological Surgery: Is There Any Benefit?

Opioid Free Anaesthesia in Oncologic Gynaecological Surgery: Is There Any Benefit? Retrospective Observational Study

To compare postoperative SIRS (Systemic Inflammatory Response) with C-Reactive Protein plasmatic level

To compare postoperative SIRS (Systemic Inflammatory Response) with Leucocytes Ratio

To compare postoperative SIRS (Systemic Inflammatory Response) with Platelet Level

Complications due to surgery which required hospitalization

To compare cancer recurrence (local and/or metastatic) 12 months after surgical treatment between groups.

To compare cancer survival 12 months after surgical treatment between groups

Instituto de Investigación Hospital Universitario La Paz

Adjuvants, Anesthesia

Anti-Arrhythmia Agents

Channel Blockers

Sufentanil

Lidocaine

Ropivacaine

Propofol

Dsuvia

Paravertebral block with an ultrasound-guided technique; opioid-free general anesthesia

Sham block by local infiltration at the same site of paravertebral block; opioid based general aneshesia

Paravertebral block will be performed at T2,T4 level on the surgical side using out-of-plane approach under ultrasound-guided, with 0.4% ropivacaine 20ml at each injection site.

paravertebral block

propofol, lidocine and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained.

opioid free anesthesia

Local infiltration at the same site of paravertebral block will be performed, with 1% lidocaine 3ml on each injection site.

sham block

propofol, sufentanil and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained .

opioid general anesthesia

Yi Feng, MD,PhD

A comparison of incidences of postoperative nausea and vomiting (PONV) , postoperative pain severity and recovery parameters in breast cancer patients receiving opioid or opioid-free general anesthesia.

Breast cancer is one of the most common oncologic diagnosis in women. Surgery is traditionally performed under general anesthesia with opioid-based analgesia. It is associated with higher incidences of PONV, more severe acute postoperative pain and increased incidences of chronic pain. The possibility of higher risk of metastasis has also been reported.

The purpose of our study is to compare the opioid-free general anesthesia with the opioid-based general anesthesia with respect to the quality of recovery, postoperative pain and cancer recurrence and metastasis.

Opioid Free Anesthesia in Breast Cancer Surgery

Opioid Free Anesthesia in Breast Cancer Surgery: a Prospective Randomized Study

15-item 15-item 15-item quality of recovery questionnaire

evaluated using EuroQol 5 dimensions questionnaire

Numeric Rating Scale pain scores, pain questionnaires

Peking University People's Hospital

Chief of the Anesthesiology Department

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Herbal and Botanical

Hydromorphone

Anesthetics, Local

Remifentanil

Instead of use of large amount of opioids for intraoperative stress response and postoperative pain controlling, during the whole perioperative period patients received no opioid at all. intravenous local anesthetics and thoracic epidural were used.

patients will receive opioid-sparing anesthesia protocol with minimal intraoperative sufentanil, remifentanil and epidural hydromorphone.

Opioid-sparing anesthesia

SHUWEI WANG

Guowei Tu

Changhong Miao

to investigate the efficacy and safety of opioid-free anesthesia for non-small-cell lung cancer resection and its underlying clinical value

Opioids used to have its irreplaceable role in standard opioid-based anesthesia, yet with the help of hypnotics, local anesthetics, anti-inflammatory drugs, α-2 agonists and epidural techniques, opioid-free anesthesia (OFA) has been proved to be safe and feasible for non-cardiac major surgeries. Opioid-sparing anesthesia (OSA) is encouraged by the needs of enhanced recovery and recommended by the latest guidelines for anesthesia of lung surgery. According to previous studies, both opioid-sparing and opioid-free anesthesia would reduce the incidence of opioid-related adverse events and speed up the postoperative recovery to some extent, yet no studies ever are dedicated to compare these two different techniques.

OFA in Thoracic Surgery

The Efficacy and Safety of Opioid-free Anesthesia(OFA) for Non-small-cell Lung Cancer Resection and Its Underlying Clinical Value: a Prospective Study

occurrence of postoperative opioid-related adverse events

relapse free survival and overall survival

occurrence of episodes of postoperative pain (VAS ≥4)

need for rescue intravenous opioids or any type of painkiller

hospital length of stay and total hospital expenses

Shanghai Zhongshan Hospital

Nervous System Diseases

Supratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Antipyretics

Anticonvulsants

Reproductive Control Agents

Anti-Inflammatory Agents

Antirheumatic Agents

Fentanyl

Dexmedetomidine

Acetaminophen

Ketamine

Magnesium Sulfate

Ketorolac

patients are going to receive intraoperative analgesics other than opioids

patients are going to receive intraoperative opioid analgesics

Patients will receive over the 10 minutes prior to induction:

* Acetaminophen 1 gm i.v. infusion in 100ml over 10 minutes.
* Ketorolac 30 mg i.v. infusion in100 ml over 10 minutes.
* Mg SO4 loading dose 30 mg/kg i.v. infusion in 100 ml over 10 minutes.
* Dexmedetomidine loading dose 1 μg/kg i.v. infusion.
* Lidocaine loading dose 1.5 mg/kg i.v. infusion.
* Ketamine loading dose 0.25 mg/kg i.v. infusion.

The weight based doses of dexmedetomidine, lidocaine, ketamine will be prepared on 20 ml syringe and infused over 10 minutes prior to induction. In a dose of 0.1 ml/kg

Then after induction maintenance analgesic infusion will start in a rate that ranges from 0.025 to 0.05 ml/kg/h which is equivalent to:

* Dexmedetomidine 0.25-0.5 μg/kg/h
* Lidocaine 0.375-0.75 mg/kg/h
* Ketamine 0.0625- 0.125 mg/kg/h

Opioid free anesthetics

Placebo equivalent to acetaminophen, ketorolac, magnesium sulphate will be infused as 100 ml normal saline each over 10 minutes ,patients will receive fentanyl 2 μg/kg loading dose which will be prepared over 20 ml syringe and infused over 10 minutes prior to induction, Then after induction maintenance of analgesic infusion by fentanyl 0.5-1 μg/kg/h.

Opioid Anesthetics

Rania S Fahmy

Hemodynamic control during craniotomies can be a bit hectic specially during periods of intense noxious stimulation. For long anesthesiologists used high doses of opioids such as fentanyl and remifentanyl to provide analgesia with a good hemodynamic control during intraoperative period in patients undergoing craniotomies. However, the use of opioids was not devoid of side effects. Exploring other anesthetic plans using multiple opioid free anesthetic adjuvants that have analgesic effects given together in small doses appear to be appealing plan. This idea is the basis of our proposed study in which we compare the hemodynamic effects of using opioid free anesthesia versus opioid anesthesia in cranial surgeries.

Anesthesia for craniotomies can be very challenging because of the presence of periods of noxious stimuli that interposes with periods of little stimulation which makes hemodynamic control a little bit more complicated. Intraoperative episodes of hypertension during periods of intense stimulations and early postoperative hypertension may lead to serious complications as post craniotomy intracranial hemorrhage and vasogenic brain edema. Anesthetic techniques based on usage of high doses of potent opioid analgesics such as fentanyl and remifentanil have been widely popular among anesthesiologists. However, the intra operative use of large bolus doses or continuous infusions of potent opioids may be associated with postoperative hyperalgesia and increased analgesic consumption.

More recently, concerns have arisen about impaired healing,immunosuppression,and worsening of oncologic outcomes with systemic opioids. Another technique that started gaining its popularity is opioid free anesthesia (OFA) technique whose corner stone is depending on multiple anesthetic adjuvants that have analgesic effects, , therefore when given together in small doses they result in good anesthesia with less side effects and faster recovery compared with opioids. This technique has been successfully used in anesthesia for bariatric surgeries combining multiple drugs as dexmedetomidine, lidocaine, ketamine, ketorolac and magnesium.

Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative, anxiolytic and analgesic properties that has minimal effects on respiratory drive. Although preoperative intravenous dexmedetomidine administration is associated with a reduction in postoperative pain intensity, analgesic consumption and nausea, the analgesic property of dexmedetomidine is less effective compared with opioids. Intravenous lidocaine has been described as having analgesic, anti-hyperalgesic, and anti-inflammatory properties. Intravenous lidocaine infusion in the perioperative period is safe and has clear advantages, such as decreased intra operative anesthetic requirements, lower pain scores, reduced postoperative analgesic requirements, as well as faster recovery. In addition to ketamine magnesium is also reported to enhance analgesia by blocking NMDA receptor, also magnesium has the properties of a sympatholytic and has been introduced as a safe component of balanced anesthesia.

This comparative study between Opioid free anesthesia (OFA) and Opioid anesthesia (OA) aims to compare the effect of both techniques on intra operative hemodynamics, intracranial tension and recovery in cranial surgeries for supratentorial tumors.

After obtaining an informed written consent from the patients or their responsible relative, patients will be divided into 2 groups randomly using computer software (research randomizer.org); Opioid free Anesthesia group (OFA) and Opioid Anesthesia group (OA). To assure blindness, numbers will be concealed by closed envelope, analgesic infusions will prepared by a clinical pharmacist not included in data collection and the attending anesthetist will be blinded to the type of analgesic solution injected.

Over 10 minutes prior to induction of analgesia patients in the OFA group will receive small doses of demedetomidine, ketamine, lidocaine and magnesium along with ketorlac and acetaminophen. an infusion afterwards will be administered through the operation containing dexmedetomidine, ketamine and lidocaine. In the OA group, over 10 minutes, patients will receive a loading dose of fentanyl followed by fentanyl infusion through the operation. General anesthesia will be induced using the same drugs and the same parameters in both groups after the completion of the initial analgesic infusions The primary outcome parameter will be the percentage of patients experiencing hemodynamic instability at Burr Hole (defined as recording an increase or decrease of the mean arterial blood pressure by 25 % of the baseline reading) Assuming the rate of hemodynamic instability (defined as increase or decrease of the mean blood pressure by 25 % of the baseline reading) would be 40 % in the control arm, a clinically meaningful reduction of the rate of hemodynamic instability to 10 % in the investigational arm with a statistical power of 80 % and an alpha error of less than 0.05 would require recruiting 29 patients in each group (a total of 58 patients).

Continuous data will be presented as mean + (SD). Categorical variables will be represented as frequencies and percentages. According to the type of data Comparison between the two groups will be performed using either Chi square test or Fisher's exact test. Hemodynamic variables will be compared to baseline using repeated measures analysis of variance (ANOVA) with post hoc scheffe's test for positive data. P values less than 0.05 will be considered statistically significant.

Opioid Free VS Opioid Anesthesia for Craniotomies

Hemodynamic Effects of Opioid Free Anesthesia Versus Opioid Anesthesia on Adult Patients Undergoing Craniotomies for Supratentorial Tumors. Randomized Controlled Trial

Defined as recording an increase or decrease of the mean arterial blood pressure by more than 25 % from baseline readings at the time of burr hole

Hemodynamic parameter recorded during the study

Defined as 1= excellently relaxed, 2= satisfactory relaxed, 3= leveled, 4=bulging

Number of patients needing nitroglycerine infusion in each group was recorded together with total amount infused

Number of patients needing ephedrine in each group was recorded together with total amount infused.

Defined as the time between the discontinuation of inhalation agents and extubation

to assess the postoperative sedation, it is a scale from 1 to 6. It provides three levels of 'awake' states (score 1-3) and three levels of 'asleep' states (score 4-6). A score of 2 (patient is cooperative, orientated and tranquil)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Opioid Free Anaesthesia in Oncologic Gynaecological Surgery: Is There Any Benefit?	NCT05448586	Cervix Cancer Endometrial Can... Ovarian Cancer Breast Cancer	Opioid	20 Years - 91 Years	Instituto de Investigación Hospital Universitario La Paz
Opioid Free Anesthesia in Breast Cancer Surgery	NCT04390698	Opioid Free Ane...	paravertebral b... opioid free ane... sham block opioid general ...	20 Years - 75 Years	Peking University People's Hospital
OFA in Thoracic Surgery	NCT05063396	Thoracic Cancer	opioid free ane... Opioid-sparing ...	18 Years - 80 Years	Shanghai Zhongshan Hospital
Opioid Free VS Opioid Anesthesia for Craniotomies	NCT04941040	Supratentorial ...	Opioid free ane... Opioid Anesthet...	18 Years - 60 Years	Kasr El Aini Hospital
Opioid Free Anesthesia in Breast Cancer Surgery	NCT04390698	Opioid Free Ane...	paravertebral b... opioid free ane... sham block opioid general ...	20 Years - 75 Years	Peking University People's Hospital
OFA in Thoracic Surgery	NCT05063396	Thoracic Cancer	opioid free ane... Opioid-sparing ...	18 Years - 80 Years	Shanghai Zhongshan Hospital
Opioid Free Anaesthesia in Oncologic Gynaecological Surgery: Is There Any Benefit?	NCT05448586	Cervix Cancer Endometrial Can... Ovarian Cancer Breast Cancer	Opioid	20 Years - 91 Years	Instituto de Investigación Hospital Universitario La Paz
Opioid Free VS Opioid Anesthesia for Craniotomies	NCT04941040	Supratentorial ...	Opioid free ane... Opioid Anesthet...	18 Years - 60 Years	Kasr El Aini Hospital

Spots Global Cancer Trial Database for opioid free anesthesia