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

Phase 2

• Conditions: Laparoscopic Cholecystectomy
• Interventions: Drug: Placebo; Drug: 300 mg of caffeine citrate infusion

• Registration Number: NCT05079880
• Lead Sponsor: Tunis University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-15
• Study First Submitted: 2021-09-21
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-03
• Last Update Submitted: 2021-10-03
• Primary Completion: 2021-10-15
• Study First Posted: 2021-10-15
• Last Update Posted: 2021-10-15
• Study Completion: 2021-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
GS group	Placebo	Equivalent saline infusion
GC group	300 mg of caffeine citrate infusion	received 300 mg of caffeine citrate infusion

Primary Outcome Measures

Name	Time	Method
anesthetic recovery time	Postoperative	time to return to spontaneous breathing, eye opening on verbal command and time for extubation

Secondary Outcome Measures

Name	Time	Method
postoperative rehabilitation	24 hours postoperatively	incidence of headache, nausea and vomiting, tiredness score, time to the first flatus and satisfaction of patients
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

Trial Locations

Locations (1)

Habib Thameur Hospital; 🇹🇳 Tunis, Tunisia