Randomized Prospective Study Comparing Sufentanil Infusion vs Intravenous Methadone for Postoperative Analgesia Following Head and Neck Dissection With Free Flap or Rotational Reconstruction
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- IV morphine equivalent
研究概览
简要总结
The main purpose of this study is to determine which type of medication, sufentanil or methadone, is better at controlling pain during and, more importantly, after surgery in patients undergoing a head and neck dissection with free flap or rotational tissue reconstruction. Prior to their operation, subjects will be randomized to receive either Sufentanil or Methadone. After surgery, research staff will obtain information about recovery and pain levels.
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)
盲法说明
The Primary investigator or his/her designee will inform the anesthesiology team caring for each subject of the am of the study they are in for each case. Subjects and research staff doing post operative assessments will be blinded to the randomization.
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
- •• Patients undergoing head and neck dissection with free flap or rotational reconstruction at Indiana University Health Adult Academic Health Center
- •ASA class 1, 2, or 3 (See Appendix)
- •Age 18 to 80
- •male or female
- •Able and willing to provide written informed consent
排除标准
- •Any contraindication to opiates, (i.e. allergy to opioids, substance use disorder) as determined by PI review and any contraindications reported by the patient
- •Patient on home methadone at any dose
- •Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery
- •Known true allergy to the study medications (sufentanil, methadone)
- •Any history of substance abuse in the past 6 months which would include heroin or any other illegal street drugs
- •End stage liver disease, end stage renal disease
- •Patient staying intubated or on mechanical ventilation after surgery
- •Patient (home dose) taking more than 30mg PO morphine equivalent (OME) per day
- •Any additional and concurrent surgical procedures to the patient
研究组 & 干预措施
Methadone
2. Intravenous methadone of 0.2 mg/kg IBW up to a maximum dose of 20mg, rounded to the nearest milligram. The methadone will be given at the beginning of the case, prior to surgical incision. n=64)
干预措施: methadone (Drug)
Sufentanil
1. Intravenous sufentanil starting at a dose of 0.5 mcg/kg/min hr ideal body weight (IBW) at the beginning of the case, prior to surgical incision, with a discontinuation of the infusion when the surgical microscope is removed from the patient field and the closure of the incision(s) begins. (n=64)
干预措施: sufentanil (Drug)
结局指标
主要结局
IV morphine equivalent
时间窗: 24 hours
Cumulative milligrams IV morphine equivalent
次要结局
- Opioid Consumption(1 hour after arrival time in post anesthesia care unit)
- Opioid Consumption(12 hour after arrival time in post anesthesia care unit)
- Pain Scores(1 hour after arrival time in post anesthesia care unit)
- Pain Scores(12 hour after arrival time in post anesthesia care unit)
- Opioid Consumption(24 hour after arrival time in post anesthesia care unit)
- Pain Scores(24 hour after arrival time in post anesthesia care unit)
- Opioid side effect - Nausea(After arrival time to post anesthesia care unit until 24 hrs./completion of study)
- Opioid side effect - Puritis(After arrival time to post anesthesia care unit until 24 hrs./completion of study)
- Opioid side effect - Respiratory Depression(After arrival time to post anesthesia care unit until 24 hrs./completion of study)
研究者
Jyoti Pankaj Dangle
Assistant Professor
Indiana University