Health TrialsbyHealthPanel

Two Intravenous Doses of Ketamine in Reducing the Oculocardiac Reflex in Adult Patients Undergoing Ophthalmic Surgery

ConditionsKetamineOculocardiac ReflexOphthalmic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCairo University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Ketamine contraindications (e.g., hypersensitivity, uncontrolled hypertension)

History of cardiac arrhythmia or conduction disorder

Glaucoma or raised intraocular pressure

ASA status greater than II

Trial design

Design model

Parallel

Treatments tested in this trial

  • 0.5 mg/kg intravenous ketamine

    Drug

    Patients will receive 0.5 mg/kg intravenous ketamine hydrochloride.

  • 0.75 mg/kg intravenous ketamine

    Drug

    Patients will receive 0.75 mg/kg intravenous ketamine hydrochloride.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
During extraocular muscle traction (intraoperative)

Secondary outcomes

1

Lowest recorded intraoperative heart rate

The lowest recorded intraoperative heart rate will be recorded.

Time frame
Intraoperatively
2

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.

Time frame
Intraoperatively
3

Mean arterial pressure

Mean arterial pressure (MAP) will be recorded throughout surgery, measured every 15 minutes.

Time frame
Every 15 minutes till the end of surgery (Up to two hours)
4

Heart rate

Heart rate (HR) will be recorded throughout surgery, measured every 15 minutes.

Time frame
Every 15 minutes till the end of surgery (Up to two hours)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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