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临床试验/NCT05079880
NCT05079880Unknown2 期

Effect of Caffeine on Time to Anesthetic Emergence After Laparoscopic Cholecystectomy : Randomized-controlled Trial

Tunis University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年8月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
60
试验地点
1
主要终点
anesthetic recovery time

研究概览

简要总结

A faster emergence from general anesthesia has a double medico-economic impact by reducing the risks of complications and optimizing the performance of surgical units. No drug has been retained for its ability to actively accelerate anesthetic emergence by antagonizing hypnotics. Thus, the aim of this study was to examine the effect of caffeine on the time to emerge from sevoflurane anesthesia for laparoscopic cholecystectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • American society of Anesthesiologists (ASA) I and II patients, aged older than 18 years old and scheduled for laparoscopic cholecystectomy

排除标准

  • Patient with an allergy to caffeine citrate and analgesics used during postoperative period, those with severe renal or hepatic failure, those who refused to participate in addition to patient with heart rhythm disorder, seizure disorder, hypertension, alcoholic or psychiatric illness

研究组 & 干预措施

GC group

Experimental

received 300 mg of caffeine citrate infusion

干预措施: 300 mg of caffeine citrate infusion (Drug)

GS group

Placebo Comparator

Equivalent saline infusion

干预措施: Placebo (Drug)

结局指标

主要结局

anesthetic recovery time

时间窗: Postoperative

time to return to spontaneous breathing, eye opening on verbal command and time for extubation

次要结局

  • postoperative rehabilitation(24 hours postoperatively)
  • postoperative pain (Visual Analog Scale score 0 "no pain" to 10 "severe pain") and consumption of morphine(24 hours postoperatively)
  • plasma caffeine levels at H1 and H24(Hour 1 and Hour 24)

研究者

发起方
Tunis University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daghmouri Mohamed Aziz

Principal investigator

Tunis University

研究点 (1)

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