Opioid-free Anesthesia in Gynecologic Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Disease
• Intervention / Treatment: Procedure: Opioid-free anesthesia; Procedure: Opioid-using anesthesia

• Study Type: Interventional
• Enrollment (Anticipated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hyo-Seok Na; Phone Number: +821087012913; Email: hsknana@gmail.com

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Seongnam, Gyeonggi, Korea, Republic of, 463-707
      • Recruiting
      • Seoul National Univ. Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group OFA (Opioid-free anesthesia); Not using opioid analgesics during laparoscopic gynecologic surgery under general anesthesia (except a single dose of alfentanil for endotracheal intubation)	Procedure: Opioid-free anesthesia; 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
Active Comparator: Group OUA (Opioid-using anesthesia); Using opioid analgesics during laparoscopic gynecologic surgery under general anesthesia (continuous infusion of remifentanil)	Procedure: Opioid-using anesthesia; 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-operative blood pressure	Blood pressure (mmHg)	Baseline, immediately before intubation, immediately after intubation, average during surgery, immediately after extubation, day of surgery(during PACU stay)
Intra-operative heart rate	Heart rate (bpm)	Baseline, immediately before intubation, immediately after intubation, average during surgery, immediately after extubation, day of surgery(during PACU stay)
Hemodynamic drug intervention	Number of intervention	Intra-operative, day of surgery(during PACU stay)

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): July 30, 2022
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: July 1, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Laparoscopy; Analgesics, opioid; Postoperative nausea; Gynecologic surgical procedures
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Vomiting; Nausea; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Anesthetics; Analgesics, Opioid
• Other Study ID Numbers: B-2006-619-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No