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NCT Number: NCT07536568

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 12613, Egypt

Location status: Recruiting

Location contact

Ahmed A Badawy, MD

SUB_INVESTIGATOR

Ahmed F Mohamed, MD

SUB_INVESTIGATOR

Ahmed Z Emam, MBBCH

PRINCIPAL_INVESTIGATOR

Ghada A Sherif, MD

CONTACT

[email protected]

00201006153615

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caffine citrate

Drug

Patients will receive sublingual caffeine at the end of surgery.

Placebo

Other

Patients will receive sublingual placebo at the end of surgery.

Primary outcomes

  1. Time to emergence

    Time frame: Till the patient opens eyes in response to a verbal command (Up to 15 minutes)

    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.

Secondary outcomes

  1. Time to discharge from post-anesthesia care unit

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

    Time to discharge from post-anesthesia care unit (PACU) will be recorded from the admission to leaving the PACU (recorded in minutes).

  2. Postoperative agitation

    Time frame: 30 minutes of post-extubation

    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 & Calm
    • 1=Drowsy=Not fully alert, but has sustained (more than 10 seconds) awakening, with eye contact, to voice
    • 2=Light sedation=Briefly (less than 10 seconds) awakens with eye contact to voice
    • 3=Moderate sedation=Any movement (but no eye contact) to voice
    • 4=Deep sedation=No response to voice, but any movement to physical stimulation
    • 5=Unarousable=No response to voice or physical stimulation

    RASS will be assessed at defined intervals: 5, 10, 15, and 30 minutes of post-extubation.

  3. Incidence of complications

    Time frame: 24 hours postoperatively

    Incidence of complications such as hypertension, tachycardia, post-operative nausea and vomiting and arrhythmias will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Ghada A Sherif, MD

CONTACT

[email protected]

00201006153615

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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