Study on Gynecological Laparoscopy Under Total Intravenous Anesthesia

Wuhan Children's Hospital

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.

Study Overview

• Status: Completed
• Conditions: Butorphanol
• Intervention / Treatment: Drug: tartaric acid butorphanol; Drug: propofol and remifentanil; Drug: normal saline

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 Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Wuhan, China
    • Wuhan Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the butorphanol group; 0.02 mg/kg of tartaric acid butorphanol intravenously 30 minutes prior to anaesthesia induction.	Drug: tartaric acid butorphanol; The group received 0.02 mg/kg tartaric acid butorphanol intravenously over 5 minutes, 30 minutes before anaesthesia induction; Drug: propofol and remifentanil; Anaesthesia was induced with 2 mg/kg propofol and 0.6 μg/kg remifentanil and maintained with a target-controlled infusion (TCI) of propofol and remifentanil, using the Marsh and Minto models, respectively.
Placebo Comparator: the control group; 0.02 mg/kg of normal saline intravenously 30 minutes prior to anaesthesia induction.	Drug: propofol and remifentanil; Anaesthesia was induced with 2 mg/kg propofol and 0.6 μg/kg remifentanil and maintained with a target-controlled infusion (TCI) of propofol and remifentanil, using the Marsh and Minto models, respectively.; Drug: normal saline; The group received 0.02 mg/kg normal saline intravenously over 5 minutes, 30 minutes before anaesthesia induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale ( VAS ) scores for pain	Pain was assessed at 1 hour to evaluate immediate postoperative pain while allowing time to recover from anaesthesia.	at 1 hour after surgery
Visual analogue scale ( VAS ) scores for pain	Pain was assessed at 2 hours after surgery.	at 2 hours after surgery
Visual analogue scale ( VAS ) scores for pain	Pain was assessed at 4 hours after surgery.	at 4 hours after surgery
Visual analogue scale ( VAS ) scores for pain	Pain was assessed at 6 hours after surgery.	at 6 hours after surgery
Visual analogue scale ( VAS ) scores for pain	Pain was assessed at 12 hours after surgery.	at 12 hours after surgery
Visual analogue scale ( VAS ) scores for pain	Pain was assessed at 24 hours after surgery.	at 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the total rescue analgesic consumption (mg)	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.	within 24 hours after surgery
the incidence of postoperative nausea and vomiting(PONV)	The incidence of postoperative nausea and vomiting(PONV) was defined as any nausea, vomiting or both	within 24 hours after surgery
the nausea severity of postoperative nausea and vomiting(PONV)	The nausea severity was rated on a 4-point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe)	within 24 hours after surgery
patient satisfaction score	Patient satisfaction was assessed using a 5-point scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied and 5 = very satisfied).	at 24 hours after surgery

Collaborators and Investigators

• Sponsor: Wuhan Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Remifentanil; Postoperative Pain; Analgesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Narcotic Antagonists; Respiratory System Agents; Antitussive Agents; Remifentanil; Propofol; Butorphanol
• Other Study ID Numbers: WHCH-008

Drug and device information, study documents

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