Effect of intraoperative dexmedetomidine on optic nerve sheath diameter as a surrogate for intracranial pressure in patients undergoing spinal surgery in prone position: A randomized controlled study.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean difference in optic nerve sheath diameter 30 minutes after establishment of prone position.
研究概览
简要总结
Prone positioning increases the intracranial pressure that can be seen by using optic nerve sheath diameter as a surrogate marker. The study will be conducted in 2 groups. Group D will receive dexmedetomidine loading dose followed by maintenance dose during the induction. The other Group N will receive Normal saline infusion that will act as the control group. The induction of anaesthesia will be done as per the standard protocols. The hypothesis of this study is that dexmedetomidine reduces the intracranial pressure that is bound to increase in the prone spinal surgeries. This reduction in intracranial pressure will be measured by measuring the optic nerve sheath diameter. The optic nerve sheath diameter should not increase in the group D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients fulfilling American Society of Anesthesiologists (ASA) physical status I- II patients.
排除标准
- •Patients with eye trauma or previous eye surgery.
- •Patients with glaucoma and ophthalmic disease other than refraction errors (myopia, hypermetropia).
- •Patients on beta blockers.
- •History of neurological disease and surgery.
- •History of increased intracranial pressure.
- •Severe Hepatic or renal disease
- •History of allergy to therapeutic drugs used in the study.
结局指标
主要结局
Mean difference in optic nerve sheath diameter 30 minutes after establishment of prone position.
时间窗: T0 : Baseline (After induction) About 5 minutes after induction, when stabilization of cardiovascular status had been achieved, baseline optic nerve sheath diameter will be measured in the supine position. | T1: 30 minutes after establishment of prone positioning. | T2: One hour after T1 | T3: At subsequent one-hour intervals | T4: After return to supine from prone position.
次要结局
- Mean difference in optic nerve sheath diameter at induction, at one hourly interval after the first reading in prone position and(after return to supine from prone position.)
- Association of duration of surgery on optic nerve sheath diameter in prone position.(After completion of the surgery and last optic nerve sheath diameter reading.)
- Mean difference in airway pressures.(1. Baseline (After induction) About 5 min after induction, when stabilization of cardiovascular status had)
- Mean difference in end tidal CO2 (EtCO2)(1. Baseline (After induction) About 5 min after induction, when stabilization of cardiovascular status had)
- Mean difference in Mean Arterial Pressure (MAP).(1. Baseline (After induction) About 5 min after induction, when stabilization of cardiovascular status had)
研究者
Dr Purva
Maulana Azad Medical College, New Delhi