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Completed

NCT Number: NCT06524596

Study on Gynecological Laparoscopy Under Total Intravenous Anesthesia

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.

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Key information

Age range

33 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wuhan Children's hospital

Wuhan, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tartaric acid butorphanol

Drug

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

normal saline

Drug

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

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.

Primary outcomes

  1. Visual analogue scale ( VAS ) scores for pain

    Time frame: at 1 hour after surgery

    Pain was assessed at 1 hour to evaluate immediate postoperative pain while allowing time to recover from anaesthesia.

  2. Visual analogue scale ( VAS ) scores for pain

    Time frame: at 2 hours after surgery

    Pain was assessed at 2 hours after surgery.

  3. Visual analogue scale ( VAS ) scores for pain

    Time frame: at 4 hours after surgery

    Pain was assessed at 4 hours after surgery.

  4. Visual analogue scale ( VAS ) scores for pain

    Time frame: at 6 hours after surgery

    Pain was assessed at 6 hours after surgery.

  5. Visual analogue scale ( VAS ) scores for pain

    Time frame: at 12 hours after surgery

    Pain was assessed at 12 hours after surgery.

  6. Visual analogue scale ( VAS ) scores for pain

    Time frame: at 24 hours after surgery

    Pain was assessed at 24 hours after surgery.

Secondary outcomes

  1. the total rescue analgesic consumption (mg)

    Time frame: 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.

  2. the incidence of postoperative nausea and vomiting(PONV)

    Time frame: within 24 hours after surgery

    The incidence of postoperative nausea and vomiting(PONV) was defined as any nausea, vomiting or both

  3. the nausea severity of postoperative nausea and vomiting(PONV)

    Time frame: within 24 hours after surgery

    The nausea severity was rated on a 4-point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe)

  4. patient satisfaction score

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Wuhan Children's Hospital

Other

Registry information

Official study title

Wuhan Children's Hospital

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 29, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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