Actively Recruiting
Efficacy of Sublingual Caffeine on Reducing Recovery Time and Postoperative Agitation in Elderly Patients Undergoing General Anesthesia: A Double-Blind Randomized Controlled Trial
Led by Cairo University · Updated on 2026-04-21
50
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of sublingual caffeine on recovery time and postoperative agitation in elderly patients undergoing general anesthesia. With an aging population, older adults face increased risks of delayed awakening and complications after surgery due to changes in how anesthesia affects their bodies. This study aims to see if caffeine, which stimulates the central nervous system, can help patients wake up faster and reduce agitation after surgery. Participants will be randomly assigned to receive either sublingual caffeine or a placebo at the end of their surgery. The caffeine acts by blocking certain receptors in the brain that promote sleep, potentially speeding recovery. This is a double-blind study, meaning neither the patients nor the researchers know who receives caffeine or placebo during the trial. During the study, researchers will measure how long it takes patients to open their eyes in response to commands and how quickly they leave the post-anesthesia care unit. They will also monitor for agitation within 30 minutes after extubation and check for any complications within 24 hours after surgery. The total participation period includes the surgery day and 24 hours of postoperative monitoring, with careful cognitive screening before surgery to ensure eligibility.
CONDITIONS
Brief Title
Sublingual Caffeine on Reducing Recovery Time and Postoperative Agitation in Elderly Patients Undergoing General Anesthesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 265 years or older.
- Both sexes are eligible.
- American Society of Anesthesiologists (ASA) physical status II.
- Scheduled for elective ophthalmology surgery under general anesthesia.
You will not qualify if you...
- History of severe cardiac arrhythmias or uncontrolled hypertension.
- ASA III patients are excluded.
- Known allergy or hypersensitivity to caffeine.
- Pre-existing cognitive impairment or dementia.
- History of seizures or epilepsy.
- History of alcohol or drug abuse.
- Chronic use of CNS stimulants or sedatives.
- Emergency surgeries.
- Surgical procedures lasting more than 3 hours.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 hours for surgery plus immediate post-operative period
Participants undergo elective ophthalmology surgery under general anesthesia and receive sublingual caffeine or placebo at the end of surgery.
1 visit on surgery day (in-person)
Duration - Up to 24 hours postoperatively
Participants are monitored for recovery including time to emergence, agitation, discharge from post-anesthesia care unit, and incidence of complications.
Assessments within 30 minutes post-extubation and monitoring until discharge from post-anesthesia care unit plus follow-up for complications
Trial Site Locations
Total: 1 location
1
Cairo University
Cairo, Egypt, 12613
Actively Recruiting
Research Team
G
Ghada A Sherif, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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