Fast-track Laparoscopic Surgery. The Effect of Anesthetic Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Amount of postoperative opioid consumption
研究概览
简要总结
In this randomized observer-blinded trial the analgesic efficacy of intravenous esmolol, as alternative to intraoperative opioids, is tested in patients undergoing laparoscopic prostatectomy and upper gastrointestinal surgery (such as Nissen fundoplication). The purpose of this study is to determine whether intravenous esmolol improves postoperative analgesia and accelerate the surgical recovery. We hypothesize that patients receiving intravenous esmolol will consume less analgesic in the postoperative period, will have less opioid-related side effects and will recover their functional status faster then patients receiving intravenous esmolol.
Patients will be stratified according to the type of surgical procedure in 2 arms: 40 patients with prostate cancer and undergoing elective laparoscopic prostatectomy, and 40 patients with gastro-esophageal reflux undergoing upper gastrointestinal surgery (Nissen funduplication) will be enrolled.
Patients will receive total intravenous anesthesia with propofol and esmolol (Esmolol group, n=20 in each arm) or propofol and remifentanil (Remifentanil Group, n=20 in each arm).
详细描述
Outcomes:
- Primary: The amount of fentanyl needed in PACU and the amount of PCA morphine used during the first 24 postoperative hours.
- Secondary: intensity of postoperative pain (visual analogue scale,VAS), opioids side effects, length of stay in PACU and in the hospital, short-term SF-36 questionnaire, CHAMPS questionnaire, and the 2 and 6 minutes walking tests.
Methodology:
In each arm patients will be assigned by computer generated random letters to two groups:
The Esmolol group: patients will receive no opioids but will receive esmolol at induction and as a continuous infusion during the surgery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with prostate cancer undergoing laparoscopic prostatectomy
- •Patients with gastro-esophageal reflux undergoing upper abdominal surgery (Nissen funduplication)
排除标准
- •Age <18 yr or > 85 yr
- •ASA physical status 3 and greater
- •History of hepatic failure (Child & Pug A-C)
- •Renal failure (creatinine outside the normal range)
- •Cardiac failure (NYHA I-IV)
- •Organ transplant
- •Diabetes mellitus type 1 and 2
- •Morbid obesity (BMI > 40)
- •Chronic use of opioids and beta-blockers
- •Severe mental impairment
- •History of allergic reactions to all the medications used in the study or inability to understand pain assessment.
- •Asthma or Reactive airway disease
- •Patient with known or suspected peritoneal adhesion
研究组 & 干预措施
Esmolol
干预措施: Esmolol (Drug)
Remifentanil
干预措施: Remifentanil (Drug)
结局指标
主要结局
Amount of postoperative opioid consumption
时间窗: End of surgery- 24hr from the end of surgery
次要结局
- Postoperative pain intensity(every 24 hr from the end of surgery)
- Incidence of opioids side-effects(during the duration of hospital stay)
- Length of stay in the PACU(time spent in the recovery room)
- Length of stay in the hospital(duration of hospitalization after the surgery)
- CHAMPS questionnaire(preoperative, at 3 and 8 weeks after the surgery)
- short-term SF-36(preoperative, at 3 and 8 weeks after the surgery)
- 2 minutes walking test(preoperative, at 4 weeks after the surgery)
- 6 minutes walking test(preoperative, at 4 weeks after the surgery)
研究者
Gabriele Baldini, MD, MSc, Assistant Professor
MD, MSc, Anesthesiologist, Assistant Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre