Effect of Caffeine on Time to Anesthetic Emergence After Laparoscopic Cholecystectomy : Randomized-controlled Trial
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2021
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 15, 2021
CompletedFirst Submitted
Initial submission to the registry
September 21, 2021
CompletedFirst Posted
Study publicly available on registry
October 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2021
CompletedOctober 15, 2021
October 1, 2021
2 months
September 21, 2021
October 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
anesthetic recovery time
time to return to spontaneous breathing, eye opening on verbal command and time for extubation
Postoperative
Secondary Outcomes (3)
plasma caffeine levels at H1 and H24
Hour 1 and Hour 24
postoperative rehabilitation
24 hours postoperatively
postoperative pain (Visual Analog Scale score 0 "no pain" to 10 "severe pain") and consumption of morphine
24 hours postoperatively
Study Arms (2)
GC group
EXPERIMENTALreceived 300 mg of caffeine citrate infusion
GS group
PLACEBO COMPARATOREquivalent saline infusion
Interventions
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
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
Eligibility Criteria
You may qualify if:
- American society of Anesthesiologists (ASA) I and II patients, aged older than 18 years old and scheduled for laparoscopic cholecystectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tunis Universitylead
Study Sites (1)
Habib Thameur Hospital
Tunis, Tunisia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
September 21, 2021
First Posted
October 15, 2021
Study Start
August 15, 2021
Primary Completion
October 15, 2021
Study Completion
October 30, 2021
Last Updated
October 15, 2021
Record last verified: 2021-10