Sublingual Caffeine on Reducing Recovery Time and Postoperative Agitation in Elderly Patients Undergoing General Anesthesia

Cairo University (CU)

Status: Enrolling

Conditions: Postoperative Agitation; Caffeine; General Anesthesia; Recovery Time; Sublingual; Elderly Patients

Treatments: Drug: Caffine citrate; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07536568

MS-688-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Caffeine group

Experimental group

Description:

Patients will receive sublingual caffeine at the end of surgery.

Treatment:

Drug: Caffine citrate

Placebo group

Placebo Comparator group

Description:

Patients will receive sublingual placebo at the end of surgery.

Treatment:

Other: Placebo