跳至主要内容
临床试验/NCT01997515
NCT01997515已完成4 期

Ketamine Effect on Recovery and Respiratory Outcomes After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study

Northwestern University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年11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
已完成
入组人数
80
试验地点
1
主要终点
Quality of Recovery 40

研究概览

简要总结

Laparoscopic surgery for gastric reduction is frequently associated with high levels of postoperative pain. Postoperative pain is very often treated with opioids. However large doses of opioids can result in respiratory depression with hypoxemia especially in high risk patients with obstructive sleep apnea. since a large group of patients undergoing surgery for gastric reduction surgery also have obstructive sleep apnea, it is expected that these patients are also at high risk for postoperative respiratory depression and hypoxemia.

Intraoperative ketamine has been used as an effective multimodal agent to reduce postoperative pain. However, ketamine alone has not been examined to improve postoperative pain outcomes in patients undergoing gastric reduction surgery. More importantly, it is unknown if the use of intraoperative ketamine can lead to better overall quality of recovery in the same patient population. In addition, ketamine has been shown to improve ventilation but it remains to be determined if the intraoperative use of ketamine will result in less postoperative hypoxemic events.

The main objective of the current investigation is to examine the effect of intraoperative ketamine on postoperative quality of recovery after gastric reduction surgery. The investigators hypothesize that subjects receiving ketamine will have a greater global quality of recovery score than the ones receiving saline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-64
  • surgery: laparoscopic gastric reduction (gastric sleeve or gastric bypass)
  • ASA physical status classification I, II, III
  • Body Mass Index >35kg/m2
  • Fluent in English

排除标准

  • History of allergy to protocol medications
  • History of chronic opioid use
  • Pregnant patients
  • Drop out: Conversion to an open surgical route, patient or surgeon request.

研究组 & 干预措施

Group K (Ketamine)

Active Comparator

Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight).

干预措施: Ketamine (Drug)

Group P (Placebo)

Placebo Comparator

Group P (placebo) will receive the same amount of saline.

干预措施: placebo (Drug)

结局指标

主要结局

Quality of Recovery 40

时间窗: 24 hours

Scores on QOR (quality of recovery) 40 questionnaire. The QoR-40 score, which ranges from 40 to 200, representing very poor (low scores) to outstanding quality of recovery (high scores), respectively.

次要结局

  • Postoperative Opioid Consumption(24 hours)
  • Postoperative Pain Scores(24 hours)
  • Length of Hospital Stay(Up to 2 weeks)

研究者

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

Meltem Yilmaz

Principal Investigator

Northwestern University

研究点 (1)

Loading locations...

相似试验

Ketamine Effect After Laparoscopic Gastric... | 临床试验