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

NCT07536568 | Recruiting

• 1 other identifier: MS-688-2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Time to discharge from post-anesthesia care unit

  Till leaving the post-anesthesia care unit (Up to 120 minutes)

• Postoperative agitation

  30 minutes of post-extubation

• Incidence of complications

  24 hours postoperatively

Study Arms (2)

Caffeine group

EXPERIMENTAL

Patients will receive sublingual caffeine at the end of surgery.

Drug: Caffine citrate

Placebo group

PLACEBO COMPARATOR

Patients will receive sublingual placebo at the end of surgery.

Other: Placebo

Interventions

Caffine citrate DRUG

Patients will receive sublingual caffeine at the end of surgery.

Caffeine group

Placebo OTHER

Patients will receive sublingual placebo at the end of surgery.

Placebo group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status II.
• Scheduled for elective ophthalmology surgery under general anesthesia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

Central Study Contacts

Ghada A Sherif, MD

CONTACT

00201006153615; drghadasherif@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management, Faculty of Medicine - Cairo University

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: April 17, 2026
• Study Start: April 18, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)