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

NCT07708740 | Recruiting

• 1 other identifier: MS-139-2026 (20-6-2026)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ketamine; Oculocardiac Reflex; Ophthalmic Surgery

Outcome Measures

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.

  During extraocular muscle traction (intraoperative)

Secondary Outcomes (6)

• Lowest recorded intraoperative heart rate

  Intraoperatively

• Incidence of use of atropine

  Intraoperatively

• Mean arterial pressure

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

• Heart rate

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

• Time to emergence

  To eye opening (Up to one hour)

Study Arms (2)

Group A

EXPERIMENTAL

Patients will receive 0.5 mg/kg intravenous ketamine hydrochloride.

Drug: 0.5 mg/kg intravenous ketamine

Group B

EXPERIMENTAL

Patients will receive 0.75 mg/kg intravenous ketamine hydrochloride.

Drug: 0.75 mg/kg intravenous ketamine

Interventions

0.5 mg/kg intravenous ketamine DRUG

Patients will receive 0.5 mg/kg intravenous ketamine hydrochloride.

Group A

0.75 mg/kg intravenous ketamine DRUG

Patients will receive 0.75 mg/kg intravenous ketamine hydrochloride.

Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

Central Study Contacts

Hebatullah S Abdelhamid, MD

CONTACT

00201044512277; drhebasalah593@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Surgical Critical Care and Pain Management Department, Faculty of Medicine, Cairo University, Cairo, Egypt.

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)