Does IV Magnesium Improve Quality of Recovery With ERAS Protocols in Laparoscopic Colorectal Surgery?
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Quality of Recovery 40 Questionnaire
研究概览
简要总结
This study is a randomized, double blind controlled trial examining the impact of incorporating a single intraoperative intravenous magnesium bolus and infusion into a preexisting Enhanced Recovery After Surgery (ERAS) protocol for colorectal surgery in place of preoperative oral pregabalin. These protocols are pathways designed with the goal of achieving early surgical recovery by utilizing a constellation of perioperative care techniques that include the use of opioid-sparing pain medications, minimally invasive approaches, and prevention of post-operative nausea and vomiting, among others. Intravenous magnesium has shown to be an effective non-opioid analgesic in abdominal surgeries that decreases total opioid consumption, pain, and improves recovery. The purpose of this study is to evaluate whether or not the addition of intravenous magnesium to our institutional ERAS protocol will improve specific outcome measures, and provide additional benefits when compared to oral preoperative pregabalin. The primary outcome is the patient's quality of recovery based on the "Quality of Recovery - 40 Questionnaire" (QOR 40), and secondary outcomes will be opioid consumption, pain, shivering, sedation scores, acute kidney injury, gastrointestinal function, respiratory function, and hospital length of stay.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elective Laparoscopic Colorectal Surgery
- •Age 18-75
- •ASA (American Society of Anesthesiologists) Physical Status Classification 1-3
排除标准
- •Current use of Buprenorphine/Suboxone or Methadone maintenance treatment
- •Known history of substance abuse
- •Use of intra- and/or postoperative Ketamine or Lidocaine infusion
- •Pre- or postoperative placement of Epidural catheter
- •Inability to speak English or communicate verbally
- •Chronic Kidney Disease (CKD) Stage 3
- •Hepatic Cirrhosis
- •Neuromuscular disease
- •Heart block on EKG
- •Uncontrolled diabetes with Hba1c > 8%
- •Known allergies to study drugs
研究组 & 干预措施
Magnesium Group
The magnesium group (Mg) will receive a bolus of 50 mg/kg of IV magnesium prior to incision and an infusion of 15 mg/kg/hr, with no preoperative oral pregabalin. All groups will receive preoperative oral acetaminophen, preoperative NSAIDs, subcutaneous heparin, intraoperative TAP block, intraoperative dexamethasone, ondansetron, transdermal scopolamine patch, and postoperative care as per the current ERAS protocol.
干预措施: IV Medications (Drug)
Control Group
The control group (Ct) will receive saline solution and no IV magnesium or oral pregabalin. All groups will receive preoperative oral acetaminophen, preoperative NSAIDs, subcutaneous heparin, intraoperative TAP block, intraoperative dexamethasone, ondansetron, transdermal scopolamine patch, and postoperative care as per the current ERAS protocol.
干预措施: placebo (Other)
结局指标
主要结局
Quality of Recovery 40 Questionnaire
时间窗: Postoperative Day 0-2
Validated Assessment of Postoperative Recovery
次要结局
未报告次要终点
研究者
Kevin Min
Assistant Professor
Thomas Jefferson University
