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

Study Overview
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Brief Summary
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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.

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

Conditions
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Laparoscopic Cholecystectomy

Intervention / Treatment
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* Drug: 300 mg of caffeine citrate infusion
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GC group<br>received 300 mg of caffeine citrate infusion | Drug: 300 mg of caffeine citrate infusion<br>* 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<br>|
| Placebo Comparator: GS group<br>Equivalent saline infusion | Drug: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma caffeine levels at H1 and H24 |  | Hour 1 and Hour 24 | 
| postoperative rehabilitation | incidence of headache, nausea and vomiting, tiredness score, time to the first flatus and satisfaction of patients | 24 hours postoperatively | 
| postoperative pain (Visual Analog Scale score 0 no pain to 10 severe pain) and consumption of morphine |  | 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caffeine, Anesthesia emergence, Cholecystectomy, Sevoflurane