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A double blind clinical trial of intravenous caffeine in accelerating awakening from total intravenous anesthesia

Effect of intravenous caffeine on accelerating awakening from total intravenous anesthesia in patients undergoing elective laparoscopic cholecystectomy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016021725600N2
Enrollment
50
Registered
2016-03-16
Start date
2016-03-20
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Awakening from general anethesia.

Interventions

Intervention 1: Control group: Single dose IV infusion of 500 milliliters of Normal Saline solution 15 minutes before end of surgery. Intervention 2: Intervention group: Single dose IV infusion of Caf
Placebo
Treatment - Drugs
Control group: Single dose IV infusion of 500 milliliters of Normal Saline solution 15 minutes before end of surgery
Intervention group: Single dose IV infusion of Caffeine Citrate in 500 milliliters of Normal Saline solution 15 minutes before end of surgery

Sponsors

Vice chancellor for research, Urmia University Of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Male and female ASA class I and II patients aged 20 to 50 scheduled for elective laparoscopic cholecystectomy using total intravenous anesthesia(TIVA) Exclusion criteria: Age above 20 and under 50 years old; ASA class >II; opioids, caffeine or caffeine containing drinks use during 8 hours before surgery; history of psychologic disorders, epilepsy, antipsychotic or antiepileptic drugs use; hepatic or cardiac diseases.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
The time interval between BIS value 80 untill BIS=60 after IV anesthetic infusion. Timepoint: Immediately after stopping IV anesthetic infusion. Method of measurement: Chronometer as second.;The time interval between BIS value 80 untill endotracheal extubation. Timepoint: Immediately after stopping IV anesthetic infusion. Method of measurement: Chronometer as second.;The time interval between BIS value 80 untill Patient's eyes opening. Timepoint: Immediately after stopping IV anesthetic infusion. Method of measurement: Chronometer as second.;Short Orientation Memory Concentration Test Score. Timepoint: 30 minutes after endotracheal extubation. Method of measurement: Short Orientation Memory Concentration Test.

Secondary

MeasureTime frame
Postoperative nausea and vomiting. Timepoint: After end of anesthesia and during stay in recovery unit. Method of measurement: By monitoring of the patient's symptoms and asking.;Mean IV anesthetic infusion dose during anesthesia in intervention and control groups. Timepoint: During maintenance of anesthesia. Method of measurement: Calculating of mean maintenance infusion dose of anesthetics as microgram per kilogram of body weight per minute.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Shahram Shokohi

Urmia University Of Medical Sciences

shokohi.sh@umsu.ac.ir; shokohi725@yahoo.com; dr.s.shokohi@gmail.com+98 44 3346 8967

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026