Opioid-free Anesthesia in Gynecologic Surgery

Study Overview
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Brief Summary
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Post-operative nausea and vomiting (PONV) is common for the patients undergoing laparoscopic gynecologic surgery. PONV is a major factor for patient dissatisfaction, delayed patient recovery and increased medical expenses. Opioid-reducing anesthetic regimen is known to decrease PONV and facilitate early recovery after surgery (ERAS) and has been widely accepted recently. In this study, the researchers intend to investigate whether opioid-free anesthesia effectively reduces PONV, and whether it is clinically safe and feasible.

Official Title
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Effect of Opioid-free General Anesthesia on Postoperative Nausea and Vomiting in Laparoscopic Gynecologic Surgery

Conditions
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Gynecologic Disease

Intervention / Treatment
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* Procedure: Opioid-free anesthesia
* Procedure: Opioid-using anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for laparoscopic gynecologic surgery (≥90 min) for benign or malignant uterine/ovarian disease Age ≥ 19 ASA (American Society of Anesthesiologists) class I-II Exclusion Criteria: Uncontrolled hypertension Untreated intracranial aneurysm Severely impaired renal or hepatic function Pregnancy History of hypersensitivity for drugs used in the study Patients not using NSAID-containing IV PCA (patient controlled analgesia) device post-operatively

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group OFA (Opioid-free anesthesia)<br>Not using opioid analgesics during laparoscopic gynecologic surgery under general anesthesia (except a single dose of alfentanil for endotracheal intubation) | Procedure: Opioid-free anesthesia<br>* Anesthesia induction: thiopental, rocuronium, desflurane + single dose of alfentanil for endotracheal intubation Anesthesia maintenance: desflurane (without any opioid) Rescue for hypertension, tachycardia: desflurane and beta blocker/calcium channel blocker<br>|
| Active Comparator: Group OUA (Opioid-using anesthesia)<br>Using opioid analgesics during laparoscopic gynecologic surgery under general anesthesia (continuous infusion of remifentanil) | Procedure: Opioid-using anesthesia<br>* Anesthesia induction: thiopental, rocuronium, desflurane + continuous infusion of remifentanil (TCI, Minto model) Anesthesia maintenance: desflurane, remifentanil Rescue for hypertension, tachycardia: desflurane, remifantanil and beta blocker/calcium channel blocker<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total incidence of post-operative nausea | Y/N | up to post-operative day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-operative nausea | Y/N | day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2 | 
| Severity of post-operative nausea | Grading: none, mild, moderate, severe | day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2 | 
| Incidence of post-operative retching/vomiting | Y/N | day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2 | 
| Rescue antiemetic agent use | Number of administration | day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2 | 
| Post-operative pain score | Grading: 11-point numeric pain scale (0-10, 10 means the worst pain) | day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2 | 
| Rescue pain medication use | Number of administration | day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesics, opioid, Postoperative nausea, Laparoscopy, Gynecologic surgical procedures