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

NCT05079880 — Phase 2, Unknown, 60 participants, Tunis University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT05079880
Status	Unknown
Phase	Phase 2
Study type	Interventional; randomized, sequential, masking: double, treatment
Enrollment	60 (Estimated)
Sponsor	Tunis University (Other)
Conditions	Laparoscopic Cholecystectomy
Interventions	300 mg of caffeine citrate infusion, Placebo (Drug)
Dates	start 2021-08-15, primary completion 2021-10-15 (estimated), completion 2021-10-30 (estimated), first posted 2021-10-15, last updated 2021-10-15
Locations	1 site in Tunisia

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
GC group	Experimental	Drug: 300 mg of caffeine citrate infusion	received 300 mg of caffeine citrate infusion
GS group	Placebo comparator	Drug: Placebo	Equivalent saline infusion

300 mg of caffeine citrate infusion (Drug): 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 (Drug): 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

+Outcome measures

Primary outcomes

anesthetic recovery time [Postoperative]: time to return to spontaneous breathing, eye opening on verbal command and time for extubation

Secondary outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Habib Thameur Hospital	Tunis	Tunisia	Recruiting

My Notes

Public

To Read Reading Read