Sublingual caffeine to shorten recovery and reduce agitation after general anesthesia in older adults
Efficacy of Sublingual Caffeine on Reducing Recovery Time and Postoperative Agitation in Elderly Patients Undergoing General Anesthesia: A Double-Blind Randomized Controlled Trial
This trial will test whether a single dose of sublingual caffeine helps people aged 65 and older wake up faster and have less postoperative agitation after elective eye surgery under general anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07536568 on ClinicalTrials.gov |
What this trial studies
This interventional study gives eligible patients either sublingual caffeine citrate or a matching placebo around the time of emergence from general anesthesia to compare recovery times and the incidence of postoperative agitation. Participants are adults aged 65 or older with ASA physical status II scheduled for elective ophthalmology procedures under general anesthesia, and those with significant cardiac disease, cognitive impairment, seizure disorders, substance abuse, or very long or emergency surgeries are excluded. Caffeine is a CNS stimulant that blocks adenosine A1/A2A receptors and has been shown to speed emergence from anesthesia in some settings, providing the biological rationale for the intervention. The study measures time to recovery and occurrence of agitation/delirium in the immediate postoperative period to determine if sublingual caffeine offers clinical benefit in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65 or older with ASA II status scheduled for elective ophthalmology surgery under general anesthesia who do not have major cardiac disease, cognitive impairment, seizures, substance abuse, or chronic use of CNS stimulants or sedatives.
Not a fit: Patients with severe systemic disease (ASA III or higher), uncontrolled arrhythmias or hypertension, known caffeine allergy, preexisting dementia, seizure disorders, substance abuse, emergency surgeries, or procedures longer than three hours are unlikely to be eligible or benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could shorten time to wakefulness and reduce episodes of postoperative agitation in older patients, potentially lowering complications and shortening hospital stays.
How similar studies have performed: Prior studies in mixed adult populations have shown that caffeine can speed emergence from anesthesia, but evidence specifically demonstrating reduced postoperative agitation or delirium in elderly surgical patients is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 65 years. * Both sexes. * American Society of Anesthesiologists (ASA) physical status II. * Scheduled for elective ophthalmology surgery under general anesthesia. Exclusion Criteria: * History of severe cardiac arrhythmias or uncontrolled hypertension. * ASA III patients were excluded to reduce the risk of adverse events in elderly patients with severe systemic diseases. * Known allergy or hypersensitivity to caffeine. * Pre-existing cognitive impairment or dementia (All patients will undergo preoperative cognitive screening using the online Mini-Cog test or Montreal Cognitive Assessment \[MoCA\]). * History of seizures or epilepsy. * History of alcohol or drug abuse. * Chronic use of CNS stimulants or sedatives. * Emergency surgeries. * Prolonged procedures for more than 3 hours.
Where this trial is running
Cairo
- Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Ghada A Sherif, MD
- Email: drghadasherif@gmail.com
- Phone: 00201006153615
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.