Sublingual Caffeine on Reducing Recovery Time and Postoperative Agitation in Elderly Patients Undergoing General Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Caffine citrate, Placebo.
- Who it may be relevant to
- Registry conditions: Sublingual, Caffeine, Recovery Time, Postoperative Agitation. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Sublingual Caffeine on Reducing Recovery Time and Postoperative Agitation in Elderly Patients Undergoing General Anesthesia: A Double-Blind Randomized Controlled Trial
Overview
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
- Drug Caffine citrate
Patients will receive sublingual caffeine at the end of surgery. - Other Placebo
Patients will receive sublingual placebo at the end of surgery.
Primary outcome measures
- Time to emergence [Time frame: Till the patient opens eyes in response to a verbal command (Up to 15 minutes)]
Secondary outcome measures (3)
- Time to discharge from post-anesthesia care unit [Time frame: Till leaving the post-anesthesia care unit (Up to 120 minutes)]
- Postoperative agitation [Time frame: 30 minutes of post-extubation]
- Incidence of complications [Time frame: 24 hours postoperatively]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Egypt · 1 center
- Cairo University — Cairo
Identifiers
NCT: NCT07536568 · MS-688-2025