Study on Gynecological Laparoscopy Under Total Intravenous Anesthesia

NCT06524596 | Completed

• 1 other identifier: WHCH-008
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Butorphanol

Keywords

Analgesia; Remifentanil; Postoperative Pain

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• the total rescue analgesic consumption (mg)

  within 24 hours after surgery

• the incidence of postoperative nausea and vomiting(PONV)

  within 24 hours after surgery

• the nausea severity of postoperative nausea and vomiting(PONV)

  within 24 hours after surgery

• patient satisfaction score

  at 24 hours after surgery

Study Arms (2)

the butorphanol group

EXPERIMENTAL

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

Drug: tartaric acid butorphanol; Drug: propofol and remifentanil

the control group

PLACEBO COMPARATOR

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

Drug: normal saline; Drug: propofol and remifentanil

Interventions

tartaric acid butorphanol DRUG

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

the butorphanol group

normal saline DRUG

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

the control group

propofol and remifentanil 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 butorphanol group; the control group

Eligibility Criteria

• Age: 33 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuhan Children's Hospital: lead

Study Sites (1)

Wuhan Children's hospital

Wuhan, China

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Saline Solution; Propofol; Remifentanil

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MM

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: May 1, 2023
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

CN (1)