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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Patients will receive 0.5 mg/kg intravenous ketamine hydrochloride. |
|
| Group B | Experimental | Patients will receive 0.75 mg/kg intravenous ketamine hydrochloride. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5 mg/kg intravenous ketamine | Drug | Patients will receive 0.5 mg/kg intravenous ketamine hydrochloride. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During extraocular muscle traction (intraoperative) |
| Measure | Description | Time Frame |
|---|---|---|
| Lowest recorded intraoperative heart rate | The lowest recorded intraoperative heart rate will be recorded. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hebatullah S Abdelhamid, MD | Contact | 00201044512277 | drhebasalah593@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | 12613 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| 0.75 mg/kg intravenous ketamine | Drug | Patients will receive 0.75 mg/kg intravenous ketamine hydrochloride. |
|
| Intraoperatively |
| Mean arterial pressure | Mean arterial pressure (MAP) will be recorded throughout surgery, measured every 15 minutes. | 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. | 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. | To eye opening (Up to one hour) |
| Incidence of postoperative complications | Incidence of postoperative complications such as nausea, vomiting, or hallucinations will be recorded. | 24 hours postoperatively |