NCT06524596

Study on Gynecological Laparoscopy Under Total Intravenous Anesthesia

Wuhan Children's Hospital

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Wuhan Children's Hospital · Academic / Other
• Sex: Female
• Age: 33 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Butorphanol

Interventions

Type	Name	Description
DRUG	tartaric acid butorphanol	The group received 0.02 mg/kg tartaric acid butorphanol intravenously over 5 minutes, 30 minutes before anaesthesia induction
DRUG	normal saline	The group received 0.02 mg/kg normal saline 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.

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-12-31
• Completion: 2023-05-01
• First posted: 2024-07-29
• Last updated: 2024-07-29

Locations

1 site across 1 country: China