Low-dose Ketamine Infusions for Perioperative Pain Management in Patients Undergoing Laparoscopic Gastric Bypass
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Total Cumulative Perioperative Opioid Dose
研究概览
简要总结
Opioid medications such as morphine, hydrocodone and oxycodone are standard for treating pain after surgery, however there are disadvantages. Because of the way opioids work, gastric bypass patients may have an increased risk of having sedation or problems with breathing. In patients with sleep apnea, opioids may increase the risk of severe apnea.
Ketamine is an alternative pain medicine that can be used to treat pain after surgery and may have fewer effects on breathing. Using ketamine as part of the regimen may be a better choice for laparoscopic gastric bypass patients.
This study is being done to find out if intraoperative ketamine infusion combined with continuation for twenty-four hours post-surgery provides superior pain control and decreases post-operative opioid use versus standard non-ketamine therapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing laparoscopic gastric bypass at Mayo Clinic in Arizona
- •BMI is ≥ 35 kg/m2
- •Consent is able to be obtained as per Mayo Clinic policy
排除标准
- •Intolerance to ketamine
- •History of schizophrenia, schizoaffective disorder, or other psychiatric diagnosis with psychotic features
- •Presence of unstable cardiovascular disease (presence of acute coronary syndrome, unstable angina, hypertension emergency, acute transient ischemic attack (TIA) or stroke)
- •Presence of acute elevation of intracranial or intraocular pressure
- •Presence of seizure disorder
- •History of substance abuse or addiction
- •Creatinine greater than 1.5 mg/dL
- •End-stage liver disease
- •Patients with chronic pain and/or chronic opioid therapy will not be excluded to more closely replicate the study patient population of interest. However, patients taking greater than 50 morphine equivalents (ME) per day for greater than 1 month prior to surgery will be excluded.
研究组 & 干预措施
Ketamine Therapy
- Ketamine 0.3 mg/kg (IBW) bolus with induction.
- Ketamine infusion 0.2 mg/kg/hr. (IBW) initiated after induction and terminated after 24 hours.
- Ketamine infusion will not be titrated.
- Remaining care will be identical to standard therapy group.
干预措施: Ketamine (Drug)
Standard Therapy
- Calculation ideal body weight (IBW)
- Pre-op dexamethasone
- Pre-op midazolam at discretion of anesthesiologist
- Anesthesia Induction - Propofol and fentanyl, anesthesiologist discretion. Neuromuscular block with succinylcholine and/or rocuronium at discretion of anesthesiologist. Orotracheal intubation.
- Anesthesia Maintenance - Sevoflurane/rocuronium. Addl. doses of fentanyl, discretion of anesthesiologist.
- Emergence from anesthesia - Acetaminophen, Ketorolac and Ondansetron unless contraindicated. Sugammadex depending on twitch response per drug manufacturer recommended protocol.
- Post-Op Analgesia - Hydromorphone, acetaminophen and ketorolac
- Other post-op care as per usual surgical routine
干预措施: Standard therapy (Drug)
结局指标
主要结局
Total Cumulative Perioperative Opioid Dose
时间窗: approximately 48 hours after induction of anesthesia
Measured in oral morphine equivalents
次要结局
- Average Pain Score 24-48 Hours(approximately 24-48 hours post operatively)
- Post-Operative Nausea(12 hours, 24 hours, and 48 hours)
- Patient Satisfaction With Pain Control at Time of Hospital Discharge(approximately 1-2 days post-operatively)
- Patient Satisfaction With Pain Control at Postoperative Visit(approximately 30 days post-operatively)
- Average Pain Score 0-12 Hours(approximately 0-12 hours post operatively)
- Average Pain Score 12-24 Hours(approximately 12-24 hours post operatively)
- Length of Stay in Hospital(Arrival at hospital until discharge from hospital, approximately 2 days)
研究者
Andrew Gorlin, MD
Assistant Professor of Anesthesiology, College of Medicine
Mayo Clinic