Cairo University
Cairo, 12613, Egypt
Location status: Recruiting
Location contact
Ahmed A Badawy, MD
SUB_INVESTIGATOR
Ahmed F Mohamed, MD
SUB_INVESTIGATOR
Ahmed Z Emam, MBBCH
PRINCIPAL_INVESTIGATOR
Ghada A Sherif, MD
CONTACT
NCT Number: NCT07536568
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Cairo, 12613, Egypt
Location status: Recruiting
Ahmed A Badawy, MD
SUB_INVESTIGATOR
Ahmed F Mohamed, MD
SUB_INVESTIGATOR
Ahmed Z Emam, MBBCH
PRINCIPAL_INVESTIGATOR
Ghada A Sherif, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive sublingual caffeine at the end of surgery.
Patients will receive sublingual placebo at the end of surgery.
Time frame: 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.
Time frame: 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).
Time frame: 30 minutes of post-extubation
Postoperative agitation will be assessed using Richmond Agitation-Sedation Scale (RASS).
RASS will be assessed at defined intervals: 5, 10, 15, and 30 minutes of post-extubation.
Time frame: 24 hours postoperatively
Incidence of complications such as hypertension, tachycardia, post-operative nausea and vomiting and arrhythmias will be recorded.
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Efficacy of Sublingual Caffeine on Reducing Recovery Time and Postoperative Agitation in Elderly Patients Undergoing General Anesthesia: A Double-Blind Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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