Magnesium and Fentanyl in Preventing Reflex Hemodynamic Response to Endotracheal Intubation in Patients Aged 50 Years and Older
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Mean Arterial Pressure (MAP) Changes
研究概览
简要总结
This prospective, randomized, controlled trial aims to evaluate the effects of magnesium sulfate and fentanyl on the hemodynamic response to endotracheal intubation in surgical patients aged 50 years and older. A total of 75 patients will be enrolled and randomized into three groups: magnesium sulfate alone, magnesium sulfate plus fentanyl, and fentanyl alone. The primary outcome measures are changes in mean arterial pressure (MAP) and heart rate before and after intubation. Secondary outcomes include BIS, SEF, ST, TOF recovery times, intraoperative hemodynamic stability, and perioperative complications.
详细描述
Endotracheal intubation can trigger significant hemodynamic changes, such as tachycardia and hypertension, due to sympathetic activation. These responses are particularly detrimental in older patients with cardiovascular comorbidities, increasing the risk of perioperative morbidity and mortality.
The aim of this study is to compare the effectiveness of magnesium sulfate and fentanyl, administered alone or in combination, in attenuating the hemodynamic response to intubation in patients aged 50 years and older undergoing elective surgery.
This is a single-center, prospective, randomized, controlled trial. A total of 75 patients will be randomized into three groups:
Group M: Magnesium sulfate 30 mg/kg IV infusion over 10 minutes Group X: Magnesium sulfate 30 mg/kg IV infusion over 10 minutes plus fentanyl 2 mcg/kg IV Group F: Fentanyl 2 mcg/kg IV Standardized anesthesia induction and monitoring will be performed. The primary outcome measures are mean arterial pressure (MAP) and heart rate, recorded at baseline, post-induction, and at 1, 3, 5, 10, and 15 minutes after intubation. Secondary outcomes include BIS, SEF, and ST values; TOF recovery times; anesthesia duration; intraoperative blood loss; fluids and blood products administered; and perioperative complications.
The findings of this study are expected to provide valuable insights into the pharmacological management of intubation-induced hemodynamic responses in the elderly surgical population.
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
- Single (Outcomes Assessor)
盲法说明
In this trial, the anesthesiologist administering the study drugs is not blinded to group allocation. However, statistical analyses will be performed by an independent researcher who is blinded to treatment assignment. Therefore, the outcomes assessor is blinded.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years
- •Patients scheduled for elective surgery under general anesthesia
- •Patients requiring endotracheal intubation with a single-lumen tube
- •Provision of written informed consent
排除标准
- •Known renal or hepatic insufficiency
- •Thyroid dysfunction
- •Uncontrolled hypertension
- •Suspected difficult airway (Mallampati ≥ 3 or history of difficult intubation)
- •Known allergy or hypersensitivity to study medications
- •Myocardial infarction within the past 3 months
- •Presence of heart block
- •Preoperative hypermagnesemia
- •Withdrawal Criteria:
- •Laryngoscopy time exceeding 20 seconds
- •Withdrawal of informed consent
- •Patient withdrawal from the study at any time
研究组 & 干预措施
Combined Magnesium Sulfate (30 mg/kg) and Fentanyl (2 mcg/kg) Group
Participants will receive magnesium sulfate 30 mg/kg intravenously over 10 minutes combined with fentanyl 2 mcg/kg intravenously
干预措施: Fentanyl (IV) (Drug)
Magnesium Sulfate Infusion Group (30 mg/kg)
Arm M: Magnesium sulfate (30 mg/kg IV over 10 min)
干预措施: magnesium sulfate (Drug)
Fentanyl Only Group (2 mcg/kg)
Participants will receive fentanyl 2 mcg/kg intravenously as a bolus
干预措施: Fentanyl (IV) (Drug)
Combined Magnesium Sulfate (30 mg/kg) and Fentanyl (2 mcg/kg) Group
Participants will receive magnesium sulfate 30 mg/kg intravenously over 10 minutes combined with fentanyl 2 mcg/kg intravenously
干预措施: magnesium sulfate (Drug)
结局指标
主要结局
Mean Arterial Pressure (MAP) Changes
时间窗: Baseline (pre-induction), immediately after induction, and at 1, 3, 5, 10, and 15 minutes after intubation.
Change in mean arterial pressure (MAP) to assess the hemodynamic response to endotracheal intubation. MAP will be measured at baseline (pre-induction), immediately after induction, and at 1, 3, 5, 10, and 15 minutes after intubation.
1. Heart Rate (HR) Changes
时间窗: Baseline (pre-induction), immediately after induction, and at 1, 3, 5, 10, and 15 minutes after intubation.
Change in heart rate to assess the hemodynamic response to endotracheal intubation. Heart rate will be measured at baseline (pre-induction), immediately after induction, and at 1, 3, 5, 10, and 15 minutes after intubation.
次要结局
- Train of Four (TOF) Recovery Time(Intraoperatively when TOF count reaches 2.)
- Perioperative Complications(From immediately after endotracheal intubation up to 15 minutes post-intubation.)