Caffeine, Elderly Patients, General Anesthesia, Postoperative Agitation, Recovery Time, Sublingual
Conditions
Brief summary
This study aims to evaluate the efficacy of sublingual caffeine in reducing recovery time and incidence of postoperative agitation in elderly patients undergoing general anesthesia.
Detailed description
With increasing life expectancy, the proportion of elderly patients undergoing surgical procedures under general anesthesia continues to rise. However, aging is associated with reduced physiological reserve and altered pharmacokinetics and pharmacodynamics of anesthetic agents, making elderly individuals particularly susceptible to delayed emergence from anesthesia. Caffeine, a methyl xanthine compound widely known for its central nervous system (CNS) stimulant properties, has shown potential to accelerate emergence from general anesthesia. It acts as a non-selective antagonist of adenosine A1 and A2A receptors, which play a role in promoting sleep and suppressing arousal. Postoperative agitation and delirium are particularly concerning in older adults due to their association with increased morbidity, functional decline, prolonged hospitalization, and even long-term cognitive impairment.
Interventions
DRUGCaffine citrate
Patients will receive sublingual caffeine at the end of surgery.
OTHERPlacebo
Patients will receive sublingual placebo at the end of surgery.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to emergence | Till the patient opens eyes in response to a verbal command (Up to 15 minutes) | Time to emergence, defined as the time interval (in minutes) from discontinuation of inhalational anesthetic agents to the moment the patient opens eyes in response to a verbal command. Measurement will be done using a stopwatch starting at anesthetic discontinuation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to discharge from post-anesthesia care unit | Till leaving the post-anesthesia care unit (Up to 120 minutes) | Time to discharge from post-anesthesia care unit (PACU) will be recorded from the admission to leaving the PACU (recorded in minutes). |
| Postoperative agitation | 30 minutes of post-extubation | Postoperative agitation will be assessed using Richmond Agitation-Sedation Scale (RASS). * 4=Combative=Overtly combative or violent; immediate danger to staff * 3=Very agitated=Pulls on or removes tube(s) or catheter(s) or has aggressive behavior toward staff * 2=Agitated=Frequent non-purposeful movement or patient-ventilator dys-synchrony * 1=Restless=Anxious or apprehensive but movements not aggressive or vigorous 0=Alert \& Calm * 1=Drowsy=Not fully alert, but has sustained (more than 10 seconds) awakening, with eye contact, to voice * 2=Light sedation=Briefly (less than 10 seconds) awakens with eye contact to voice * 3=Moderate sedation=Any movement (but no eye contact) to voice * 4=Deep sedation=No response to voice, but any movement to physical stimulation * 5=Unarousable=No response to voice or physical stimulation RASS will be assessed at defined intervals: 5, 10, 15, and 30 minutes of post-extubation. |
| Incidence of complications | 24 hours postoperatively | Incidence of complications such as hypertension, tachycardia, post-operative nausea and vomiting and arrhythmias will be recorded. |
Countries
Egypt
Contacts
CONTACTGhada A Sherif, MD
Outcome results
None listed