Evaluation of Two Intravenous Doses of Ketamine in Reducing the Oculocardiac Reflex in Adult Patients Undergoing Ophthalmic Surgery: A Randomized Controlled Double-Blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of oculocardiac reflex
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of oculocardiac reflex
时间窗: 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.
次要结局
- 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))
- Incidence of postoperative complications(24 hours postoperatively)
研究者
Hebatallah Salah Abdelhamid
Lecturer of Anesthesia, Surgical Critical Care and Pain Management Department, Faculty of Medicine, Cairo University, Cairo, Egypt.
Cairo University