Study on Gynecological Laparoscopy Under Total Intravenous Anesthesia

Not Applicable

Completed

• Conditions: Butorphanol
• Interventions: Drug: tartaric acid butorphanol; Drug: normal saline; Drug: propofol and remifentanil

• Registration Number: NCT06524596
• Lead Sponsor: Wuhan Children's Hospital

Brief Summary

To investigate the effect of preemptive analgesia with tartaric acid butorphanol on postoperative pain in gynecological laparoscopy under total intravenous anesthesia with remifentanil.This randomised, double-blind, placebo-controlled trial enrolled 60 patients undergoing elective gynaecological laparoscopy. The patients were divided into two groups: the butorphanol group (n = 30) and the control group (n = 29). Both groups received TIVA with propofol and remifentanil. Observing two groups of patients on the visual analog scale, the total consumption of rescue analogies, and the confidence of postoperative nausea and vomiting (PONV), and the patient satisfaction score.

Detailed Description

To investigate the effect of preemptive analgesia with tartaric acid butorphanol on postoperative pain in gynecological laparoscopy under total intravenous anesthesia with remifentanil.This randomised, double-blind, placebo-controlled trial enrolled 60 patients undergoing elective gynaecological laparoscopy. The patients were divided into two groups: the butorphanol group (n = 30), who received 0.02 mg/kg of tartaric acid butorphanol intravenously 30 minutes prior to anaesthesia induction, and the control group (n = 29), who received the same volume of normal saline. Both groups received TIVA with propofol and remifentanil. The primary outcome was the visual analogue scale (VAS) score for pain at rest and on movement at 1, 2, 4, 6, 12 and 24 hours after surgery. The secondary outcomes were the total consumption of rescue analgesics, the incidence and severity of postoperative nausea and vomiting (PONV), and the patient satisfaction score.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-05-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-23
• Study First Submitted QC: 2024-07-23
• Last Update Submitted: 2024-07-23
• Study First Posted: 2024-07-29
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 59

Inclusion Criteria

• women patients, aged 18-65 years, with an American Society of Anesthesiologists physical status of I or II
• undergoing elective gynaecological laparoscopy for benign diseases

Exclusion Criteria

• patients who had an allergy or contraindication to any study drug
• had chronic pain or opioid use
• had a history of substance abuse or psychiatric disorders
• were pregnant or lactating
• had a severe cardiovascular, respiratory, renal, hepatic or haematological disease
• had a body mass index >30 kg/m2
• had an inability to understand or cooperate with study procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the butorphanol group	propofol and remifentanil	0.02 mg/kg of tartaric acid butorphanol intravenously 30 minutes prior to anaesthesia induction.
the butorphanol group	tartaric acid butorphanol	0.02 mg/kg of tartaric acid butorphanol intravenously 30 minutes prior to anaesthesia induction.
the control group	normal saline	0.02 mg/kg of normal saline intravenously 30 minutes prior to anaesthesia induction.
the control group	propofol and remifentanil	0.02 mg/kg of normal saline intravenously 30 minutes prior to anaesthesia induction.

Primary Outcome Measures

Name	Time	Method
Visual analogue scale ( VAS ) scores for pain	at 24 hours after surgery	Pain was assessed at 24 hours after surgery.

Secondary Outcome Measures

Name	Time	Method
the nausea severity of postoperative nausea and vomiting(PONV)	within 24 hours after surgery	The nausea severity was rated on a 4-point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe)
the total rescue analgesic consumption (mg)	within 24 hours after surgery	The total rescue analgesic consumption was calculated by adding the amount of morphine delivered by PCA and any supplemental tramadol given by the nurse for inadequate pain control (VAS \>4) or at the patient's request, ensuring that the total opioid dose was within safe limits.
the incidence of postoperative nausea and vomiting(PONV)	within 24 hours after surgery	The incidence of postoperative nausea and vomiting(PONV) was defined as any nausea, vomiting or both
patient satisfaction score	at 24 hours after surgery	Patient satisfaction was assessed using a 5-point scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied and 5 = very satisfied).

Trial Locations

Locations (1)

Wuhan Children's hospital; 🇨🇳 Wuhan, China