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

Efficacy of Sublingual Caffeine on Reducing Recovery Time and Postoperative Agitation in Elderly Patients Undergoing General Anesthesia: A Double-Blind Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: General Anesthesia; Elderly Patients; Caffeine; Recovery Time; Postoperative Agitation; Sublingual
• Intervention / Treatment: Drug: Caffine citrate; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ghada A Sherif, MD; Phone Number: 00201006153615; Email: drghadasherif@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 12613
    • Recruiting
    • Cairo University
    • Sub-Investigator: Ahmed F Mohamed, MD
    • Contact: Ghada A Sherif, MD; Phone Number: 00201006153615; Email: drghadasherif@gmail.com
    • Principal Investigator: Ahmed Z Emam, MBBCH
    • Sub-Investigator: Ahmed A Badawy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caffeine group; Patients will receive sublingual caffeine at the end of surgery.	Drug: Caffine citrate; Patients will receive sublingual caffeine at the end of surgery.
Placebo Comparator: Placebo group; Patients will receive sublingual placebo at the end of surgery.	Other: Placebo; Patients will receive sublingual placebo at the end of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	Postoperative agitation will be assessed using Richmond Agitation-Sedation Scale (RASS).; 4=Combative=Overtly combative or violent; immediate danger to staff; 3=Very agitated=Pulls on or removes tube(s) or catheter(s) or has aggressive behavior toward staff; 2=Agitated=Frequent non-purposeful movement or patient-ventilator dys-synchrony; 1=Restless=Anxious or apprehensive but movements not aggressive or vigorous 0=Alert & Calm1=Drowsy=Not fully alert, but has sustained (more than 10 seconds) awakening, with eye contact, to voice2=Light sedation=Briefly (less than 10 seconds) awakens with eye contact to voice3=Moderate sedation=Any movement (but no eye contact) to voice4=Deep sedation=No response to voice, but any movement to physical stimulation5=Unarousable=No response to voice or physical stimulation 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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: April 11, 2026
• First Submitted That Met QC Criteria: April 11, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 18, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MS-688-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No