Opioid-free Anesthesia in Gynecologic Surgery

Seoul National University

Status: Enrolling

Conditions: Gynecologic Disease

Treatments: Procedure: Opioid-using anesthesia; Procedure: Opioid-free anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04700761

B-2006-619-004

Details and patient eligibility

About

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.

Enrollment: 164 estimated patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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164 participants in 2 patient groups

Group OFA (Opioid-free anesthesia)

Experimental group

Description:

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

Treatment:

Procedure: Opioid-free anesthesia

Group OUA (Opioid-using anesthesia)

Active Comparator group

Description:

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

Treatment:

Procedure: Opioid-using anesthesia