Opioid-free Anesthesia in Gynecologic Surgery

Not Applicable

• Conditions: Gynecologic Disease
• Interventions: Procedure: Opioid-free anesthesia; Procedure: Opioid-using anesthesia

• Registration Number: NCT04700761
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-08
• Study Start: 2021-02-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-01
• Last Update Posted: 2022-07-05
• Primary Completion: 2022-07-30
• Study Completion: 2022-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 164

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group OFA (Opioid-free anesthesia)	Opioid-free anesthesia	Not using opioid analgesics during laparoscopic gynecologic surgery under general anesthesia (except a single dose of alfentanil for endotracheal intubation)
Group OUA (Opioid-using anesthesia)	Opioid-using anesthesia	Using opioid analgesics during laparoscopic gynecologic surgery under general anesthesia (continuous infusion of remifentanil)

Primary Outcome Measures

Name	Time	Method
Total incidence of post-operative nausea	up to post-operative day 2	Y/N

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National Univ. Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of