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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caffeine group | Experimental | Patients will receive sublingual caffeine at the end of surgery. |
|
| Placebo group | Placebo Comparator | Patients will receive sublingual placebo at the end of surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffine citrate | Drug | Patients will receive sublingual caffeine at the end of surgery. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time 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. | Till the patient opens eyes in response to a verbal command (Up to 15 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Till leaving the post-anesthesia care unit (Up to 120 minutes) |
| Postoperative agitation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ghada A Sherif, MD | Contact | 00201006153615 | drghadasherif@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | 12613 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| Placebo |
| Other |
Patients will receive sublingual placebo at the end of surgery. |
|
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. |
| 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. | 24 hours postoperatively |