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

Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05079880
• Other study ID #: HTHEC-2017-09
• Status: Recruiting
• Phase: Phase 2
• Start date: August 15, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: October 2021
• Source: Tunis University
• Contact: Mohamed Aziz DAGHMOURI, M.D
• Phone: 0021629442474
• Email: aziz.daghmouri[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 30, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Drug:
• 300 mg of caffeine citrate infusion
At the end of the surgery, the study drug was given intravenously over ten minutes than the sevoflurane infusion was stopped corresponding to the start of the recovery period
• Placebo
At the end of the surgery, the placebo was given intravenously over ten minutes than the sevoflurane infusion was stopped corresponding to the start of the recovery period

Locations

Country	Name	City	State
Tunisia	Habib Thameur Hospital	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Tunis University

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anesthetic recovery time	time to return to spontaneous breathing, eye opening on verbal command and time for extubation	Postoperative
Secondary	plasma caffeine levels at H1 and H24		Hour 1 and Hour 24
Secondary	postoperative rehabilitation	incidence of headache, nausea and vomiting, tiredness score, time to the first flatus and satisfaction of patients	24 hours postoperatively
Secondary	postoperative pain (Visual Analog Scale score 0 "no pain" to 10 "severe pain") and consumption of morphine		24 hours postoperatively