A Randomized Control Trial Evaluating the Utility of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to first flatus
研究概览
简要总结
The objective of this study is to determine if an opioid-free general anesthetic (OFA) technique utilizing lidocaine, ketamine, dexmedetomidine and magnesium reduce postoperative opioid consumption and speed return of bowel function in patients undergoing elective, laparoscopic, colorectal surgery compared to traditional opioid-containing general anesthetic techniques. It is hypothesized that this intraoperative OFA regimen will reduce postoperative opioid consumption, and expedite return of bowel function in this population.
详细描述
The objective of this trial is to determine whether an opioid-free general anesthetic can help reduce postoperative opioid consumption and speed return of bowel function in patients undergoing elective, laparoscopic, colorectal surgery when compared with traditional opioid-containing techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18, American Society of Anesthesiology (ASA) class I-III patients scheduled for elective laparoscopic/laparoscopic assisted colorectal surgery
排除标准
- •Emergency surgery, open surgery, contraindications to laparoscopic surgery (ie. adhesions, inability to tolerate pneumoperitoneum), American Society of Anesthesiology (ASA) class 4, age < 18, pregnant or breastfeeding women, significant cardiorespiratory/hepatic/renal disease, allergy to any study drugs, inability to consent, inability to respond to pain assessments, inability to use the patient controlled analgesia device (PCA)
研究组 & 干预措施
Opioid-free General Anesthesia (OFA)
Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis.
干预措施: Acetaminophen, Gabapentin (Drug)
Opioid-free General Anesthesia (OFA)
Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis.
干预措施: Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine (Drug)
Opioid-free General Anesthesia (OFA)
Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis.
干预措施: Dexamethasone, Ondansetron (Drug)
Opioid-free General Anesthesia (OFA)
Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis.
干预措施: Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium Sulfate (Drug)
Traditional Opioid-containing General Anesthesia (TOA)
Opioid-sparing preoperative medications, Opioid-containing pre-intubation medications, Opioid-containing maintenance medications, postoperative nausea and vomiting prophylaxis.
干预措施: Acetaminophen, Gabapentin (Drug)
Traditional Opioid-containing General Anesthesia (TOA)
Opioid-sparing preoperative medications, Opioid-containing pre-intubation medications, Opioid-containing maintenance medications, postoperative nausea and vomiting prophylaxis.
干预措施: Dexamethasone, Ondansetron (Drug)
Traditional Opioid-containing General Anesthesia (TOA)
Opioid-sparing preoperative medications, Opioid-containing pre-intubation medications, Opioid-containing maintenance medications, postoperative nausea and vomiting prophylaxis.
干预措施: Lidocaine 1% Injectable Solution, Sufentanil (Drug)
Traditional Opioid-containing General Anesthesia (TOA)
Opioid-sparing preoperative medications, Opioid-containing pre-intubation medications, Opioid-containing maintenance medications, postoperative nausea and vomiting prophylaxis.
干预措施: Sevoflurane, Sufentanil (Drug)
结局指标
主要结局
Time to first flatus
时间窗: End of surgery to first flatus (1-4 days)
Time between the end of surgery and the movement when the patient first passes flatus
次要结局
- Quality of recovery after surgery(End of surgery to time of patient discharge from hospital (2-10 days))
- Time to tolerance of oral intake(End of surgery to first oral intake (1-3 days))
- Patient Controlled Analgesia (PCA) morphine consumption(End of surgery to 48 hours postoperatively)
- Time to Post-Anesthetic Care Unit (PACU) discharge readiness(End of surgery to PACU discharge readiness (1-3 hours))
- Time to first defecation(End of surgery to first defecation (1-7 days))
- Visual Analogue Scale (VAS) pain scores(End of surgery to 48 hours postoperatively)
- Total Post-Anesthetic Care Unit (PACU) opioid consumption(End of surgery to discharge from PACU (1-2 hours))
研究者
Jonathan Gamble
Anesthesiologist
University of Saskatchewan