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临床试验/NCT04434430
NCT04434430已完成1 期

Effectiveness of Preemptive Oral Gabapentin 600 mg on Morphine Requirement After Non Obstetric Lower Abdominal Surgery

Indonesia University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2019年11月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
72
试验地点
1
主要终点
Cumulative morphine requirement within 24 hours after non obstetric lower abdominal surgery

研究概览

简要总结

This study aimed to get the information about the effectiveness of preemptive oral gabapentin 600 mg in reducing morphine requirement after non obstetric lower abdominal surgery

详细描述

Seventy-two subjects were given informed consent before enrolling the study and randomized into two groups; gabapentin and placebo. Two hours before the incision, patients were given preemptive analgesia, either gabapentin or placebo. Non-invasive blood pressure monitor, electrocardiogram (ECG), and pulse oxymetry were set on the subjects in the operating room. General anesthesia induction was done by fentanyl 2 mcg/kg and propofol 2 mg/kg. Endotracheal tube (ETT) intubation was facilitated with atracurium 0.5 mg/kg as muscle relaxant. Maintenance was done by sevoflurane, oxygen, and compressed air. After surgery, patients were extubated until fully conscious. Patients will be transported to recovery room postoperatively. Besides paracetamol as the postoperative analgesia, we also attached patient controlled analgesia (PCA) system to patients' intravenous line using continuous ambulatory delivery device (CADD) contained morphine 1 mg/ml with settings 1 mg per requirement, interval limit within 5 minutes, maximum dose 6 mg/hour intravenously. Cumulative morphine requirement, mean visual analogue scale, and time interval after surgery to the first administration of morphine will be assessed in this study.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Gabapentin

Active Comparator

Patient will receive preemptive oral gabapentin 600 mg

干预措施: Gabapentin (Drug)

Placebo

Placebo Comparator

Patient will receive oral placebo

干预措施: Placebo (Other)

结局指标

主要结局

Cumulative morphine requirement within 24 hours after non obstetric lower abdominal surgery

时间窗: 24 hours after surgery

Measured by total consumption of morphine on patient controlled analgesia machine

Pain within 24 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale

时间窗: 24 hours after surgery

Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences. The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.

次要结局

  • Cumulative morphine requirement within 12 hours after non obstetric lower abdominal surgery(12 hours after surgery)
  • Pain within 2 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale(2 hours after surgery)
  • Pain within 6 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale(6 hours after surgery)
  • Pain within 12 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale(12 hours after surgery)
  • Cumulative morphine requirement within 2 hours after non obstetric lower abdominal surgery(2 hours after surgery)
  • Cumulative morphine requirement within 6 hours after non obstetric lower abdominal surgery(6 hours after surgery)

研究者

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

Andi Ade Wijaya Ramlan

Principal Investigator

Indonesia University

研究点 (1)

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