Clinical trial NCT06524596: Study on Gynecological Laparoscopy Under Total Intravenous Anesthesia
Official title: Wuhan Children's Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Butorphanol
Keywords: Analgesia
Remifentanil
Postoperative Pain
Lead sponsor: Wuhan Children's Hospital
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 59
Sex: FEMALE
Minimum age (years): 33
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual analogue scale ( VAS ) scores for pain
timeFrame: at 1 hour after surgery
measure: Visual analogue scale ( VAS ) scores for pain
timeFrame: at 2 hours after surgery
measure: Visual analogue scale ( VAS ) scores for pain
timeFrame: at 4 hours after surgery
measure: Visual analogue scale ( VAS ) scores for pain
timeFrame: at 6 hours after surgery
measure: Visual analogue scale ( VAS ) scores for pain
timeFrame: at 12 hours after surgery
measure: Visual analogue scale ( VAS ) scores for pain
timeFrame: at 24 hours after surgery
Secondary outcomes:
measure: the total rescue analgesic consumption (mg)
timeFrame: within 24 hours after surgery
measure: the incidence of postoperative nausea and vomiting(PONV)
timeFrame: within 24 hours after surgery
measure: the nausea severity of postoperative nausea and vomiting(PONV)
timeFrame: within 24 hours after surgery
measure: patient satisfaction score
timeFrame: at 24 hours after surgery
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Children's hospital
Study officials:
References: