KetamineNCT07708740
Two Intravenous Doses of Ketamine in Reducing the Oculocardiac Reflex in Adult Patients Undergoing Ophthalmic Surgery
A study testing 0.5 mg/kg intravenous ketamine and 0.75 mg/kg intravenous ketamine in people with Ketamine and Oculocardiac Reflex, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to evaluate whether a lower dose of ketamine (0.5 mg/kg IV) may be as effective as a higher dose (0.75 mg/kg IV) in reducing oculocardiac reflex (OCR) incidence in adult patients undergoing ophthalmic surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ketamine, Oculocardiac Reflex, Ophthalmic Surgery
- What is being tested?
- 0.5 mg/kg intravenous ketamine and 0.75 mg/kg intravenous ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 30 Dec 2027
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years old.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I, II.
- Scheduled for elective ophthalmic surgery involving extraocular muscle traction under general anesthesia.
Who cannot join
- Ketamine contraindications (e.g., hypersensitivity, uncontrolled hypertension)
- History of cardiac arrhythmia or conduction disorder
- Glaucoma or raised intraocular pressure
- ASA status greater than II
- Patient refusal.
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
Hebatullah S Abdelhamid, MD, 00201044512277, drhebasalah593@gmail.com
About this study
Official title: Evaluation of Two Intravenous Doses of Ketamine in Reducing the Oculocardiac Reflex in Adult Patients Undergoing Ophthalmic Surgery: A Randomized Controlled Double-Blinded Trial
This study aims to evaluate whether a lower dose of ketamine (0.5 mg/kg IV) may be as effective as a higher dose (0.75 mg/kg IV) in reducing oculocardiac reflex (OCR) incidence in adult patients undergoing ophthalmic surgery.
Read the detailed description
The oculocardiac reflex (OCR) is a trigeminovagal reflex that can occur intraoperatively due to traction on extraocular muscles or pressure on the globe, resulting in bradycardia, arrhythmias, or asystole. Defined as a heart rate drop exceeding 20% from baseline, OCR is most frequently described in pediatric strabismus surgery, though its relevance persists in adult ophthalmic interventions involving similar stimuli.
Optimal ketamine dosing in adults remains underexplored. Higher doses may enhance OCR protection but could also prolong emergence or increase psychomimetic effects.
- Conditions
- Ketamine, Oculocardiac Reflex, Ophthalmic Surgery
- Being tested
- 0.5 mg/kg intravenous ketamine, 0.75 mg/kg intravenous ketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5 mg/kg intravenous ketamineDrug
Patients will receive 0.5 mg/kg intravenous ketamine hydrochloride.
0.75 mg/kg intravenous ketamineDrug
Patients will receive 0.75 mg/kg intravenous ketamine hydrochloride.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients will receive 0.5 mg/kg intravenous ketamine hydrochloride. Receives: Drug: 0.5 mg/kg intravenous ketamine |
| Group B | Experimental | Patients will receive 0.75 mg/kg intravenous ketamine hydrochloride. Receives: Drug: 0.75 mg/kg intravenous ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of oculocardiac reflex
Incidence of oculocardiac reflex (OCR) in each group [defined as ≥20% heart rate decrease from baseline or absolute bradycardia (HR<50 bpm)] sustained during extraocular muscles (EOMs) traction.
Measured: During extraocular muscle traction (intraoperative)
Secondary outcomes (6)
Lowest recorded intraoperative heart rate
The lowest recorded intraoperative heart rate will be recorded.
Measured: Intraoperatively
Incidence of use of atropine
If oculocardiac reflex (OCR) (defined as >20% drop in heart rate from the baseline or absolute bradycardia <50 bpm) occurs, the surgeon will be ordered to stop extraocular muscle traction, and atropine increments (0.3 mg IV) will be administered.
Measured: Intraoperatively
Mean arterial pressure
Mean arterial pressure (MAP) will be recorded throughout surgery, measured every 15 minutes.
Measured: Every 15 minutes till the end of surgery (Up to two hours)
Heart rate
Heart rate (HR) will be recorded throughout surgery, measured every 15 minutes.
Measured: Every 15 minutes till the end of surgery (Up to two hours)
Time to emergence
Time to emergence from anesthesia will be recorded from the conclusion of anesthesia to eye opening.
Measured: To eye opening (Up to one hour)
Incidence of postoperative complications
Incidence of postoperative complications such as nausea, vomiting, or hallucinations 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 posted16 Jul 2026
- Study start1 Jul 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KetamineStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hebatallah Salah Abdelhamid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708740
- Sponsor's protocol ID
- MS-139-2026 (20-6-2026)
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 16 Jul 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Intravenous Doses of Ketamine in Reducing the Oculocardiac Reflex in Adult Patients Undergoing Ophthalmic Surgery: A Randomized Controlled Double-Blinded Trial
- ClinicalTrials.gov ID
- NCT07708740
- Acronym / sponsor ID
- MS-139-2026 (20-6-2026)
- Conditions
- Ketamine, Oculocardiac Reflex, Ophthalmic Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 16 Jul 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 whether a lower dose of ketamine (0.5 mg/kg IV) may be as effective as a higher dose (0.75 mg/kg IV) in reducing oculocardiac reflex (OCR) incidence in adult patients undergoing ophthalmic surgery.
Detailed description
The oculocardiac reflex (OCR) is a trigeminovagal reflex that can occur intraoperatively due to traction on extraocular muscles or pressure on the globe, resulting in bradycardia, arrhythmias, or asystole. Defined as a heart rate drop exceeding 20% from baseline, OCR is most frequently described in pediatric strabismus surgery, though its relevance persists in adult ophthalmic interventions involving similar stimuli.
Optimal ketamine dosing in adults remains underexplored. Higher doses may enhance OCR protection but could also prolong emergence or increase psychomimetic effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: 0.5 mg/kg intravenous ketaminePatients will receive 0.5 mg/kg intravenous ketamine hydrochloride. |
| Group B | Experimental | Drug: 0.75 mg/kg intravenous ketaminePatients will receive 0.75 mg/kg intravenous ketamine hydrochloride. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 65 years old.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I, II.
- Scheduled for elective ophthalmic surgery involving extraocular muscle traction under general anesthesia.
Key exclusion criteria (5 listed)
- Ketamine contraindications (e.g., hypersensitivity, uncontrolled hypertension)
- History of cardiac arrhythmia or conduction disorder
- Glaucoma or raised intraocular pressure
- ASA status greater than II
- Patient refusal.
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 |
|---|---|---|
| 0.5 mg/kg intravenous ketaminePatients will receive 0.5 mg/kg intravenous ketamine hydrochloride. | Drug | Group A |
| 0.75 mg/kg intravenous ketaminePatients will receive 0.75 mg/kg intravenous ketamine hydrochloride. | Drug | Group B |
Primary outcome
Incidence of oculocardiac reflex
Time frame: During extraocular muscle traction (intraoperative)
Incidence of oculocardiac reflex (OCR) in each group [defined as ≥20% heart rate decrease from baseline or absolute bradycardia (HR<50 bpm)] sustained during extraocular muscles (EOMs) traction.
6 secondary outcomes
Lowest recorded intraoperative heart rate
Time frame: Intraoperatively
Incidence of use of atropine
Time frame: Intraoperatively
Mean arterial pressure
Time frame: Every 15 minutes till the end of surgery (Up to two hours)
Heart rate
Time frame: Every 15 minutes till the end of surgery (Up to two hours)
Time to emergence
Time frame: To eye opening (Up to one hour)
Incidence of postoperative 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 16 Jul 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 0.5 mg/kg intravenous ketamine and 0.75 mg/kg intravenous ketamine in people with Ketamine and Oculocardiac Reflex, 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 5 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 16 Jul 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. 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 Hebatullah S Abdelhamid, MD (00201044512277, drhebasalah593@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of oculocardiac reflex (time frame: During extraocular muscle traction (intraoperative)). 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 16 Jul 2026.