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临床试验/NCT03052673
NCT03052673已完成4 期

Per-operative Low-Dose Ketamine For Postoperative Pain Relief In Patients Undergoing Bariatric Surgery: A Randomised Study

Sir Ganga Ram Hospital1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2017年2月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
76
试验地点
1
主要终点
Postoperative Fentanyl Consumption in micrograms

研究概览

简要总结

The surgical interventions for treating morbid obesity, i.e. bypass procedure and sleeve gastrectomy are collectively covered under the term 'bariatric surgery'. The growth of bariatric surgery has seen consonant development of anaesthesia techniques so as to ensure patient safety and facilitate post-surgery outcome. Conventionally, balanced general anaesthesia techniques routinely use opioids peri-operatively for intra-operative haemodynamic homeostasis and postoperative pain relief. However, since the morbidly obese patients have high prevalence of obstructive sleep apnea(OSA) and other co-morbidities the same technique when employed in the morbidly obese patients hampers early and intermediate postoperative recovery due to the occurrence of side effects, such as, sedation, PONV, respiratory depression, depressed GI-mobility. The above stated side effects, have lead to increased propensity for postoperative cardiac and pulmonary complications. Obese patients are more vulnerable and sensitive to the narcotics and sedatives, these drugs need to be employed judiciously in these patients. On the other hand, the reduction in opioid use may result in acute post-operative pain that may limit post-surgery rehabilitation. Therefore, we need to minimise opioid use and employ some other drugs which besides having analgesia, has a opioid-sparing effect also.

Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has analgesic properties in sub-anaesthetic doses. When used in low dose (0.2mg/kg), it is an analgesic, anti-hyperalgesic, and prevents development of opioid tolerance. On a conceptual basis, a key advantage of ketamine is that it can reduces post-operative pain and use of opioid when used per-operatively. Therefore, a regimen which avoid or minimise use of opioid is likely to decrease opioid-related postoperative morbidity in these patients undergoing bariatric surgery.In view of the above, a clinical research is highly desirable to study techniques to decrease the use of opioids in obese surgical patients.This prospective randomised two-arm study aims to assess the effect of low-dose ketamine on postoperative pain relief and opioid-sparing ability in obese patients undergoing bariatric surgery.

详细描述

After obtaining approval from the hospital ethics committee and written informed consent from the patients, this prospective randomised study will be conducted on 76 patients belonging to ASA physical patients status II and III of either sex, scheduled to undergo laparoscopic bariatric surgery (sleeve gastrectomy, Roux-en-Y gastric bypass) under general anaesthesia. The patients will be randomly allocated by computer generated numbers to one of the following two groups of 38 patients each.

Group 1[Ketamine + Fentanyl Group, n=38]: Pre-induction fentanyl 1-mcg/kg, ketamine 0.5-mg/kg after induction, followed by intra-operative fentanyl infusion of 0.5-mcg/kg/hr + ketamine infusion of 0.2-mg/kg/hr

Group 2[Fentanyl Group, n=38]: Pre-induction fentanyl 1-mcg/kg, saline after induction followed by intra-operative fentanyl infusion of 0.5-mcg/kg/hr + saline infusion.

Both the groups will receive intravenous PCA of fentanyl post-operatively.

Randomisation, Allocation Concealment:

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)

盲法说明

The patient and the attending anaesthesiologist will be blinded to the intraoperative infusions used. Postoperative patient recovery profile will also be evaluated by an independent assess or blinded to the intraoperative anaesthesia technique.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of age 18-60 years
  • BMI > 35 kg/m2
  • Either sex
  • ASA physical status II & III
  • undergoing laparoscopic bariatric surgery

排除标准

  • Patients refusal
  • ASA physical status: IV
  • History of hypersensitivity to fentanyl and/or ketamine
  • Chronic opioid use
  • History of substance abuse
  • Metabolic disorders
  • Seizure disorder

研究组 & 干预措施

Ketamine + Fentanyl Group

Active Comparator

Patients will receive pre-induction fentanyl 1-mcg/kg, ketamine 0.5-mg/kg after induction, followed by intraoperative fentanyl infusion of 0.5-mcg/kg/hr + ketamine infusion of 0.2-mg/kg/hr.

Postoperative analgesia will be provided with Intravenous Patient Controlled Analgesia (IV-PCA) pump containing fentanyl citrate-2.5 mcg/ml, which will be attached to all the patients upon shifting to the recovery room. The IV-PCA pump settings will be as follows: 0-ml basal dose; 4-ml PCA dose; 15-minutes lock out interval.

干预措施: Fentanyl (Drug)

Ketamine + Fentanyl Group

Active Comparator

Patients will receive pre-induction fentanyl 1-mcg/kg, ketamine 0.5-mg/kg after induction, followed by intraoperative fentanyl infusion of 0.5-mcg/kg/hr + ketamine infusion of 0.2-mg/kg/hr.

Postoperative analgesia will be provided with Intravenous Patient Controlled Analgesia (IV-PCA) pump containing fentanyl citrate-2.5 mcg/ml, which will be attached to all the patients upon shifting to the recovery room. The IV-PCA pump settings will be as follows: 0-ml basal dose; 4-ml PCA dose; 15-minutes lock out interval.

干预措施: ketamine (Drug)

Fentanyl Group

Active Comparator

Patients will receive pre-induction fentanyl 1-mcg/kg,followed by intraoperative fentanyl infusion of 0.5-mcg/kg/hr.

Postoperative analgesia will be provided with Intravenous Patient Controlled Analgesia (IV-PCA) pump containing fentanyl citrate-2.5 mcg/ml, which will be attached to all the patients upon shifting to the recovery room. The IV-PCA pump settings will be as follows: 0-ml basal dose; 4-ml PCA dose; 15-minutes lock out interval.

干预措施: Fentanyl (Drug)

结局指标

主要结局

Postoperative Fentanyl Consumption in micrograms

时间窗: From end of anaesthesia till 24-hours postoperatively

Amount of fentanyl consumed using the IV-PCA pump will be calculated

Efficacy of Postoperative Analgesia

时间窗: From end of anaesthesia till 24-hours postoperatively

will be assessed using visual analogue scale (VAS) score

次要结局

  • Postoperative Sedation(From end of anaesthesia till 24-hours postoperatively)
  • Time to eye opening in minutes(From end of anaesthesia till 20-minutes postoperatively)
  • Changes in intraoperative blood pressure- systolic, diastolic, and mean (mmHg)(From beginning of anesthesia (0-hours, baseline) till 6 hours intraoperatively)
  • Postoperative Nausea and Vomiting(From end of anaesthesia till 24-hours postoperatively)
  • Time to extubation in minutes(From end of anaesthesia till 30-minutes postoperatively)
  • Changes in intraoperative heart rate (beats per minute)(From beginning of anesthesia (0-hours, baseline) till 6 hours intraoperatively)

研究者

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

Dr Nitin Sethi

Doctor & Associate Professor

Sir Ganga Ram Hospital

研究点 (1)

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