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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
50
Patients will receive sublingual caffeine at the end of surgery.
Patients will receive sublingual placebo at the end of surgery.
Cairo University
Cairo, Egypt
RECRUITINGTime to emergence
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.
Time frame: Till the patient opens eyes in response to a verbal command (Up to 15 minutes)
Time to discharge from post-anesthesia care unit
Time to discharge from post-anesthesia care unit (PACU) will be recorded from the admission to leaving the PACU (recorded in minutes).
Time frame: Till leaving the post-anesthesia care unit (Up to 120 minutes)
Postoperative agitation
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.
Time frame: 30 minutes of post-extubation
Incidence of complications
Incidence of complications such as hypertension, tachycardia, post-operative nausea and vomiting and arrhythmias will be recorded.
Time frame: 24 hours postoperatively
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