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

ConditionsSublingualCaffeineRecovery TimePostoperative AgitationElderly PatientsGeneral Anesthesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorCairo University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 65 years.

Both sexes.

American Society of Anesthesiologists (ASA) physical status II.

Scheduled for elective ophthalmology surgery under general anesthesia.

Disqualifiers

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]).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Caffine citrate

    Drug

    Patients will receive sublingual caffeine at the end of surgery.

  • Placebo

    Other intervention

    Patients will receive sublingual placebo at the end of surgery.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Caffeine groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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).

Time frame
Till leaving the post-anesthesia care unit (Up to 120 minutes)
2

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 \& 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.

Time frame
30 minutes of post-extubation
3

Incidence of complications

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

Time frame
24 hours postoperatively

Other outcomes

Sponsors and contacts

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Cairo University

Lead sponsor

Source ClinicalTrials.gov
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