Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Total Hydromorphone Use
研究概览
简要总结
Opioid sparing analgesia is extremely important in the post-operative obese population. With more and more obese patients entering the operating room a multi-modal approach to analgesia is crucial. Finding effective alternatives to opioid therapy is the rationale of this proposal. Literature involving ketamine and magnesium in bariatric surgical patients is very sparse.
详细描述
- Patient will be identified by surgeon and consented by member of the research team
- Patient will be randomized to one of three groups on the day of surgery
- Following securement of the endotracheal tube, the study medication will be administered over 10 minutes via an IV infusion pump.
- The subject will receive ketamine, ketamine plus magnesium or a placebo.
- Following surgery, the patient will be taken to the post anesthesia care unit (PACU) and set up with standard ASA monitoring as well as end-tidal CO2 via nasal cannula. A hydromorphone patient controlled analgesia (PCA) pump will be set-up by nursing and given to the patient. Standard dosing of 0.2 mg bolus, every 6 minutes with a maximum 2 mg will be the starting dose as is standard for these patients post-operatively.
- Primary outcome will be the total amount of hydromorphone used in the first 24 hours post-operatively.
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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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing laparoscopic sleeve gastrectomy
- •Consenting adults age 18-80
- •ASA II to ASA III
- •Ability to understand and use a PCA
- •Required to be hospitalized for at least 24 hours post-op
排除标准
- •Patient refusal
- •Chronic opiate use (daily opiate use for >3 months)
- •Chronic Kidney disease (Creatinine>2)
- •Known allergy or adverse effect of ketamine, magnesium or hydromorphone
- •Patients with documented psychiatry (Maniac or MDP) history
- •Patient unable to give informed consent
- •Patient with limited or no English fluency
研究组 & 干预措施
Ketamine
Ketamine: 0.5 mg/kg IV dose
干预措施: Ketamine (Drug)
Ketamine
Ketamine: 0.5 mg/kg IV dose
干预措施: Placebo (Other)
Ketamine plus magnesium
Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV
干预措施: Ketamine plus magnesium (Drug)
Placebo
Placebo (normal saline)
干预措施: Placebo (Other)
结局指标
主要结局
Total Hydromorphone Use
时间窗: During surgery and 24 hours post-op
Total hydromorphone use in 1st 24 hours post-operatively.
次要结局
- Pain Scores Using Verbal Analogue Scale (VAS)(Preoperatively and the 1st 24 hours post-op)
- Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane(Intraoperative period)
研究者
Sanjib D Adhikary
Associate professor, Department of Anesthesiology,
Milton S. Hershey Medical Center