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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05079880

Enrollment

Registered

2021-10-15

Start date

2021-08-15

Completion date

2021-10-30

Last updated

2021-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Cholecystectomy

Keywords

Caffeine, Anesthesia emergence, Cholecystectomy, Sevoflurane

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.

Interventions

DRUG300 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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
anesthetic recovery time	Postoperative	time to return to spontaneous breathing, eye opening on verbal command and time for extubation

Secondary

Measure	Time frame	Description
plasma caffeine levels at H1 and H24	Hour 1 and Hour 24	—
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	—

Countries

Tunisia

Contacts

Primary ContactMohamed Aziz DAGHMOURI, M.D

aziz.daghmouri@gmail.com0021629442474

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026