Study on Gynecological Laparoscopy Under Total Intravenous Anesthesia

Wuhan Children's Hospital

Status: Completed

Conditions: Butorphanol

Treatments: Drug: tartaric acid butorphanol; Drug: normal saline; Drug: propofol and remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT06524596

WHCH-008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: Female

Ages: 33 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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59 participants in 2 patient groups, including a placebo group

the butorphanol group

Experimental group

Description:

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

Treatment:

Drug: propofol and remifentanil

Drug: tartaric acid butorphanol

the control group

Placebo Comparator group

Description:

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

Treatment:

Drug: propofol and remifentanil

Drug: normal saline