Wuhan Children's Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Visual analogue scale ( VAS ) scores for pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 33 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
the control group
0.02 mg/kg of normal saline intravenously 30 minutes prior to anaesthesia induction.
干预措施: normal saline (Drug)
the butorphanol group
0.02 mg/kg of tartaric acid butorphanol intravenously 30 minutes prior to anaesthesia induction.
干预措施: tartaric acid butorphanol (Drug)
the butorphanol group
0.02 mg/kg of tartaric acid butorphanol intravenously 30 minutes prior to anaesthesia induction.
干预措施: propofol and remifentanil (Drug)
the control group
0.02 mg/kg of normal saline intravenously 30 minutes prior to anaesthesia induction.
干预措施: propofol and remifentanil (Drug)
结局指标
主要结局
Visual analogue scale ( VAS ) scores for pain
时间窗: at 24 hours after surgery
Pain was assessed at 24 hours after surgery.
次要结局
- the nausea severity of postoperative nausea and vomiting(PONV)(within 24 hours after surgery)
- the total rescue analgesic consumption (mg)(within 24 hours after surgery)
- the incidence of postoperative nausea and vomiting(PONV)(within 24 hours after surgery)
- patient satisfaction score(at 24 hours after surgery)
研究者
Xiang Wang
MM
Wuhan Children's Hospital