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临床试验/NCT03001843
NCT03001843已完成4 期

Does a Ketamine Infusion Decrease Post Operative Narcotic Consumption After Gastric Bypass Surgery?

University of Florida1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2017年2月22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
54
试验地点
1
主要终点
Pain Measured Based on Pain Medication Used on a Scale of 0-10

研究概览

简要总结

This study will help to determine if investigators can minimize narcotic use in laparoscopic gastric bypass patients while maintaining adequate pain control. This will allow investigators to minimize the negative side effects of narcotics which is a goal in this population.

详细描述

The study will be a head to head observational study of patients who have undergone gastric bypass surgery. The methods of intraoperative anesthesiology will be Ketamine or Narcotic. Both are FDA approved methods of delivering anesthesia.

The amount of narcotics a patient receives is part of the medical record post-operatively will be followed from post-anesthesia care unit (PACU) through to discharge. The amount of narcotics needed to control the patient's pain (converted to morphine equivalent units) and pain scores (a hospital standard measure) will be collected for 48 hours for the study, or until discharge, whichever occurs sooner. The conversion to a morphine equivalent unit allows investigators to compare different narcotics the patient may receive in a more standardized way. The results will be analyzed and compared between the two groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

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

  • Obese patient presenting for laparoscopic gastric bypass between 18 and 65 years of age

排除标准

  • Hypersensitivity, allergy, or contraindications to fentanyl, propofol, or ketamine.

研究组 & 干预措施

Non-Ketamine

Active Comparator

This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine.

干预措施: Narcotics (Drug)

Non-Ketamine

Active Comparator

This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine.

干预措施: pain scale (Behavioral)

Ketamine

Active Comparator

This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.

干预措施: Ketamine (Drug)

Ketamine

Active Comparator

This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain.

干预措施: pain scale (Behavioral)

结局指标

主要结局

Pain Measured Based on Pain Medication Used on a Scale of 0-10

时间窗: 48 hours

Used to translate the dose and route of each of the opioids the patient has received over the last 48 hours to a parenteral morphine equivalent using a standard conversion table. SD standard deviation, mg: milligrams, pain measured on a 0-10 scale

次要结局

  • Length of Stay (Hours)(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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