SublingualNCT07536568
Sublingual Caffeine on Reducing Recovery Time and Postoperative Agitation in Elderly Patients Undergoing General Anesthesia
A study testing Caffine citrate in people with Sublingual and Caffeine, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sublingual, Caffeine, Recovery Time
- What is being tested?
- Caffine citrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Apr 2026to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status II.
- Scheduled for elective ophthalmology surgery under general anesthesia.
Who cannot join
- 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.
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- Chronic use of CNS stimulants or sedatives.
- Emergency surgeries.
- Prolonged procedures for more than 3 hours.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 12613
Ghada A Sherif, MD, 00201006153615, drghadasherif@gmail.com
Ahmed Z Emam, MBBCH
About this study
Official title: 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.
Read the 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.
- Conditions
- Sublingual, Caffeine, Recovery Time, Postoperative Agitation, Elderly Patients, General Anesthesia
- Being tested
- Caffine citrate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffine citrateDrug
Patients will receive sublingual caffeine at the end of surgery.
PlaceboOther
Patients will receive sublingual placebo at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Caffeine group | Experimental | Patients will receive sublingual caffeine at the end of surgery. Receives: Drug: Caffine citrate |
| Placebo group | Placebo comparator | Patients will receive sublingual placebo at the end of surgery. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Time to discharge from post-anesthesia care unit (PACU) will be recorded from the admission to leaving the PACU (recorded in minutes).
Measured: 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 \& 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.
Measured: 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.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start18 Apr 2026
- Primary completion15 Jul 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SublingualStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada AboBakr Mohamed Sherif, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536568
- Sponsor's protocol ID
- MS-688-2025
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sublingual Caffeine on Reducing Recovery Time and Postoperative Agitation in Elderly Patients Undergoing General Anesthesia: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07536568
- Acronym / sponsor ID
- MS-688-2025
- Conditions
- Sublingual, Caffeine, Recovery Time, Postoperative Agitation, Elderly Patients, General Anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Apr 2026 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine group | Experimental | Drug: Caffine citratePatients will receive sublingual caffeine at the end of surgery. |
| Placebo group | Placebo comparator | Other: PlaceboPatients will receive sublingual placebo at the end of surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥ 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status II.
- Scheduled for elective ophthalmology surgery under general anesthesia.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffine citratePatients will receive sublingual caffeine at the end of surgery. | Drug | Caffeine group |
| PlaceboPatients will receive sublingual placebo at the end of surgery. | Other | Placebo group |
Primary outcome
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.
3 secondary outcomes
Time to discharge from post-anesthesia care unit
Time frame: Till leaving the post-anesthesia care unit (Up to 120 minutes)
Postoperative agitation
Time frame: 30 minutes of post-extubation
Incidence of complications
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffine citrate in people with Sublingual and Caffeine, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ghada A Sherif, MD (00201006153615, drghadasherif@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to emergence (time frame: Till the patient opens eyes in response to a verbal command (Up to 15 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.