Effects of Intravenous Dexmedetomidine Versus Lidocaine on Optic Nerve Sheath Diameter During Endotracheal Intubation in Patients Undergoing Craniotomy: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Optic Nerve Sheath Diameter
研究概览
简要总结
Endotracheal intubation during general anesthesia can cause temporary increases in heart rate, blood pressure, and intracranial pressure. These changes may be particularly important in patients undergoing craniotomy. Optic nerve sheath diameter, measured noninvasively using ultrasound, can be used as an indirect marker of changes in intracranial pressure.
This randomized controlled trial will compare intravenous dexmedetomidine, intravenous lidocaine, and normal saline in patients undergoing elective supratentorial craniotomy under general anesthesia. The study will evaluate whether dexmedetomidine or lidocaine can reduce changes in optic nerve sheath diameter associated with endotracheal intubation and improve hemodynamic stability compared with placebo.
The investigators hypothesize that dexmedetomidine and lidocaine will attenuate the increase in optic nerve sheath diameter and the hemodynamic response associated with endotracheal intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and the investigator responsible for data collection and outcome assessment will be blinded to group allocation. Study medications will be prepared by an independent anesthesiologist who will not participate in patient management, data collection, or outcome assessment.
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
- •Adults aged 18 to 65 years
- •Male or female participants
- •American Society of Anesthesiologists physical status I to III
- •Scheduled for elective supratentorial craniotomy under general anesthesia
排除标准
- •Raised intraocular pressure
- •Pre-existing eye disease or ocular injury
- •Severe cardiac or pulmonary disease
- •Hepatic or renal impairment
- •Coagulopathy
- •Pregnancy
- •Known allergy to any of the study drugs
- •Difficult airway
- •Emergency craniotomy
研究组 & 干预措施
Dexmedetomidine Group
Participants will receive dexmedetomidine 1 microgram per kilogram intravenously, diluted in 100 milliliters of normal saline and administered over 10 minutes before induction of anesthesia.
干预措施: Dexmedetomidine (Drug)
Control Group
Participants will receive normal saline placebo intravenously before induction of anesthesia, administered in a manner intended to maintain study blinding.
干预措施: Normal Saline (Drug)
Lidocaine Group
Participants will receive lidocaine 1.5 milligrams per kilogram intravenously as a slow bolus 2-3 minutes before induction of anesthesia.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Optic Nerve Sheath Diameter
时间窗: Perioperative: baseline before induction; immediately after induction before laryngoscopy; immediately after intubation; 5 and 10 minutes after intubation.
Optic nerve sheath diameter will be measured in millimeters using ultrasonography with a high-frequency linear probe placed gently over the closed upper eyelid. The measurement will be obtained 3 millimeters posterior to the globe.
次要结局
- Heart Rate(Perioperative: baseline before induction; immediately after induction before laryngoscopy; and 1, 5, and 10 minutes after intubation.)
- Mean Arterial Pressure(Perioperative: baseline before induction of general anesthesia; immediately after completion of induction and before laryngoscopy; and 1, 5, and 10 minutes after endotracheal intubation.)
- Systolic Blood Pressure(Perioperative: baseline before induction; immediately after induction before laryngoscopy; and 1, 5, and 10 minutes after intubation.)
- Diastolic Blood Pressure(Perioperative: baseline before induction; immediately after induction before laryngoscopy; and 1, 5, and 10 minutes after intubation.)
- Incidence of Intraoperative Hemodynamic Adverse Events(Intraoperatively)
研究者
Ahmed Salem Thabet
Resident of Anesthesia, Intensive Care and Pain Management
Benha University