Opioid-free Anesthesia in Gynecologic Surgery

NCT04700761 | Unknown

• 1 other identifier: B-2006-619-004
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Disease

Keywords

Analgesics, opioid; Postoperative nausea; Laparoscopy; Gynecologic surgical procedures

Outcome Measures

Primary Outcomes (1)

• Total incidence of post-operative nausea

  Y/N

  up to post-operative day 2

Secondary Outcomes (6)

• Incidence of post-operative nausea

  day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2

• Severity of post-operative nausea

  day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2

• Incidence of post-operative retching/vomiting

  day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2

• Rescue antiemetic agent use

  day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2

• Post-operative pain score

  day of surgery(during PACU stay), day of surgery(at ward), postoperative day 1, postoperative day 2

Other Outcomes (3)

• Intra-operative blood pressure

  Baseline, immediately before intubation, immediately after intubation, average during surgery, immediately after extubation, day of surgery(during PACU stay)

• Intra-operative heart rate

  Baseline, immediately before intubation, immediately after intubation, average during surgery, immediately after extubation, day of surgery(during PACU stay)

• Hemodynamic drug intervention

  Intra-operative, day of surgery(during PACU stay)

Study Arms (2)

Group OFA (Opioid-free anesthesia)

EXPERIMENTAL

Not using opioid analgesics during laparoscopic gynecologic surgery under general anesthesia (except a single dose of alfentanil for endotracheal intubation)

Procedure: Opioid-free anesthesia

Group OUA (Opioid-using anesthesia)

ACTIVE COMPARATOR

Using opioid analgesics during laparoscopic gynecologic surgery under general anesthesia (continuous infusion of remifentanil)

Procedure: Opioid-using anesthesia

Interventions

Opioid-free anesthesia PROCEDURE

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

Group OFA (Opioid-free anesthesia)

Opioid-using anesthesia PROCEDURE

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

Group OUA (Opioid-using anesthesia)

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National Univ. Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Genital Diseases, Female; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Central Study Contacts

Hyo-Seok Na

CONTACT

+821087012913; hsknana@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: January 8, 2021
• Study Start: February 1, 2021
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-07

Locations

KR (1)