A comparative study to evaluate effect of two doses of dexmedetomidine on hemodynamic changes, sedation score and requirement of propofol in patients undergoing surgery under general anaesthesia in a tertiary care hospital.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 1.To compare the effects of two doses of dexmedetomidine (0.5 µg/kg and 1.0 µg/kg) on hemodynamic changes in patients undergoing surgery.
研究概览
简要总结
Several clinical studies have investigated the hemodynamic effects of dexmedetomidine across different dosages. A study by Ueshima et al. demonstrated that a dose of 0.5 mcg per kg of dexmedetomidine resulted in significant attenuation of the stress response without a notable increase in side effects. On the other hand, doses around 1.0 mcg per kg have shown greater efficacy in reducing heart rate and blood pressure, but with an increased incidence of bradycardia and hypotension. The optimal dose for achieving a balance between effective hemodynamic control and minimal adverse effects remains a subject of ongoing research.
Given these findings, the present randomized, double-blind, prospective study aims to evaluate and compare the hemodynamic effects of intravenous dexmedetomidine at doses of 0.5 mcg per kg versus 1.0 mcg per kg in patients undergoing major surgeries under general anaesthesia. The goal is to identify the most effective and safe dosage regimen to optimize perioperative hemodynamic stability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients undergoing elective surgeries under general anaesthesia(GA).
- •2.ASA(American Society of Anaesthesiologists) classification grade I or II.
排除标准
- 未提供
结局指标
主要结局
1.To compare the effects of two doses of dexmedetomidine (0.5 µg/kg and 1.0 µg/kg) on hemodynamic changes in patients undergoing surgery.
时间窗: 1. Baseline | 2. 10 minutes after Dexmedetomidine administration | 3. Immediately after induction | 4. Immediately after intubation | 5. 1 minute after intubation | 6. 5 minutes after intubation | 7. 10 minutes after intubation
2.To study and compare the sedation score with two different dose of dexmedetomidine (0.5 µg/kg and 1.0 µg/kg).
时间窗: 1. Baseline | 2. 10 minutes after Dexmedetomidine administration | 3. Immediately after induction | 4. Immediately after intubation | 5. 1 minute after intubation | 6. 5 minutes after intubation | 7. 10 minutes after intubation
3.To study requirement of propofol in patients according to Dexmedetomidine dose.
时间窗: 1. Baseline | 2. 10 minutes after Dexmedetomidine administration | 3. Immediately after induction | 4. Immediately after intubation | 5. 1 minute after intubation | 6. 5 minutes after intubation | 7. 10 minutes after intubation
次要结局
- 1.To study side effects related to dexmedetomidine if any.(1. Baseline)
研究者
BHATT JAINEEL DEVANG
GCS MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE