Study on Gynecological Laparoscopy Under Total Intravenous Anesthesia

NCT ID: NCT06524596

Last Updated: 2024-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-05-01

Brief Summary

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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

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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

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Butorphanol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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the butorphanol group

0.02 mg/kg of tartaric acid butorphanol intravenously 30 minutes prior to anaesthesia induction.

Group Type EXPERIMENTAL

tartaric acid butorphanol

Intervention Type DRUG

The group received 0.02 mg/kg tartaric acid butorphanol intravenously over 5 minutes, 30 minutes before anaesthesia induction

propofol and remifentanil

Intervention Type DRUG

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.

the control group

0.02 mg/kg of normal saline intravenously 30 minutes prior to anaesthesia induction.

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

The group received 0.02 mg/kg normal saline intravenously over 5 minutes, 30 minutes before anaesthesia induction

propofol and remifentanil

Intervention Type DRUG

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.

Interventions

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tartaric acid butorphanol

The group received 0.02 mg/kg tartaric acid butorphanol intravenously over 5 minutes, 30 minutes before anaesthesia induction

Intervention Type DRUG

normal saline

The group received 0.02 mg/kg normal saline intravenously over 5 minutes, 30 minutes before anaesthesia induction

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

33 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wuhan Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiang Wang

MM

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wuhan Children's hospital

Wuhan, , China

Site Status

Countries

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China

Other Identifiers

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WHCH-008

Identifier Type: -

Identifier Source: org_study_id

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