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临床试验/NCT02252432
NCT02252432终止4 期

Intraoperative Ketamine and Methadone for Laminectomy: Effect on Recovery, Postoperative Pain, and Opioid Requirements

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
13
试验地点
1
主要终点
Postoperative Pain

研究概览

简要总结

The purpose of this research is to determine the pain-reducing effects of ketamine (Ketalar, an FDA-approved drug for anesthesia) and methadone (Dolophine, a long-acting narcotic) after lumbar laminectomy. The investigators would like to evaluate whether intraoperative use of both drugs may be able to provide better control of pain after lumbar surgery.

详细描述

During and after the surgery, patients undergoing surgery most likely need narcotics (opioids) that can cause side effects such as drowsiness and constipation. This can delay your recovery. The investigator would like to determine if the intraoperative use of ketamine and methadone will provide better pain control and reduce the use of narcotic painkiller medications (analgesics) after lumbar surgery as compared to either drug (ketamine or methadone) alone.

Ketamine is used to help to reduce the amount of the commonly used intravenous anesthetic drugs, minimize heart rate and blood pressure instability during surgery, and to improve outcomes after surgery (e.g. less pain, less constipation, less nausea and vomiting after surgery, faster return of bowel function and shortened length of hospital stay).

Ketamine is approved by the U.S. Food and Drug Administration (FDA) to be used: as an anesthetic and analgesic (painkiller). Ketamine is an "adjuvant," which is a drug that may increase the effectiveness or strength of other drugs when given at the same time. Ketamine is administered as an adjuvant during anesthesia to produce anesthetic and analgesic-sparing effects (reduce the amount of anesthetics and narcotics-painkiller drugs), hemodynamic stability (to maintain the blood pressure and heart rate within normal rank) and side effect reduction (e.g., constipation, nausea and vomiting, itching, and urinary retention). Ketamine will be used as approved in this study. Ketamine is frequently used intraoperatively for pain control in patients undergoing spine surgery at our institution and is within the standard of care. The standard of care indicates that this is one possible method which has been demonstrated to be safe and effective for patient care. This may vary at different institutions.

Methadone is approved by the U.S. Food and Drug Administration (FDA) to be used: as an opioid pain reliever, similar to morphine, and for narcotic detoxification to reduce withdrawal symptoms. The dose of methadone that will be used in this study may be slightly higher than the approved dose depending on the subject's weight. However, this dose of methadone is frequently used intraoperatively for pain control in patients undergoing spine surgery at our institution and is within the standard of care. This may vary at different institutions.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

入选标准

  • 18 - 80 years old of either gender, scheduled for elective lumbar laminectomy

排除标准

  • American Society of Anesthesiologists (ASA) IV and above
  • Intolerance, allergy, or contraindication to use of any medications used in this study
  • Significant coronary artery disease (abnormal stress test, myocardial infarction
  • within the last 3 months)
  • Increased intraocular pressure (e.g., untreated glaucoma)
  • Uncontrolled hypertension (BP > 140/90)
  • Sleep apnea and currently on continuous positive airway pressure (CPAP)
  • Increased intracranial pressure or clinical signs thereof
  • History of intracranial surgery, stroke, or brain aneurysm
  • Cardiac arrhythmias particularly prolonged QT syndrome
  • Drugs known to cause prolonged qT: class (IA) antiarrhythmics (quinidine, procainamide, disopyramide), class III antiarrhythmics (sotalol, dofetilide, ibutilide, amiodarone), haloperidol, thioridazine, arsenic trioxide, HIV protease inhibitors, tricyclic antidepressants
  • Individuals with significant psychological disorders including: schizophrenia, mania, bipolar disorder or psychosis
  • Pregnant or lactating women
  • Emergent laminectomy
  • Those already receiving ketamine or methadone prior to surgery
  • Morbid obesity (BMI > 40 kg/m2) AND/OR weight > 150 kg
  • Chronic renal failure ( creatinine > 2.0 mg/dL)
  • Liver failure e.g., active cirrhosis
  • Alcohol or substance abuse within in the past 3 months
  • Uncorrected hypokalemia, hypomagnesemia, hypocalcemia (can be due to diuretics, mineralocorticoid use, laxatives)
  • Chronic obstructive pulmonary disease (COPD)/Hypercarbia
  • Restrictive lung disease (pulmonary fibrosis, myasthenia gravis)
  • Congestive heart failure
  • Thyroid disease
  • Organ transplant patients
  • Drugs/substances known to inhibit methadone metabolism: macrolide antibiotics e.g., erythromycin, cimetidine, astemizole, voriconazole, grapefruit juice

研究组 & 干预措施

Ketamine

Active Comparator

A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min))

干预措施: Methadone (Drug)

Ketamine

Active Comparator

A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min))

干预措施: Ketamine + methadone (Drug)

Methadone

Active Comparator

Will receive a single dose of IV methadone (0.2 mg/kg) preinduction

干预措施: Ketamine (Drug)

Methadone

Active Comparator

Will receive a single dose of IV methadone (0.2 mg/kg) preinduction

干预措施: Ketamine + methadone (Drug)

Ketamine + methadone

Experimental

Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)

干预措施: Ketamine (Drug)

Ketamine + methadone

Experimental

Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)

干预措施: Methadone (Drug)

结局指标

主要结局

Postoperative Pain

时间窗: 1 day

Postoperative pain was measured at PACU using a Verbal Rating Scale from 0 to 10. Where 0= no pain and 10= maximum pain experienced

Opioid Consumption Obtained From the Recorded Data

时间窗: 1 day

Perioperative use of opioid consumption inside the hospital (recorded by study staff and data obtained from patient charts)

次要结局

  • Nausea and Vomiting(1 day)
  • Number of Participants With Constipation at Follow up(3 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Roya Yumul, M.D.,PhD.

Principal Investigator

Cedars-Sinai Medical Center

研究点 (1)

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