A Comparative study between Remifentanil and Fentanyl in attenuation of hemodynamic response to Laryngoscopy and Tracheal Intubation in patients undergoing General Anesthesia requiring Endotracheal Intubation– A double blinded randomized controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To compare the efficacy of bolus dose of remifentanil (2μg/kg) and bolus dose of fentanyl (2μg/kg) in attenuating heart rate response to laryngoscopy and intubation in patients undergoing General Anesthesia.
研究概览
简要总结
The hemodynamic response to laryngoscopy and intubation is represented by an abrupt rise in the heart rate and arterial blood pressure within 30 seconds and returning to the baseline values steadily within 5-10 minutes . opioids with short half life has proven advantages over fentanyl for modulating circulatory responses to intubation . Remifentanil is s novel opioid drug with a distinct chemical structure . owing to its rapid onset and quick half-life , it would be the opioid of choice for attenuating the pressor response to a brief but unpleasant stimulus.
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
- •Age 18 – 60 years of either sex.
- •American society of Anesthesiologist 1 and 2 patients.
- •(ASA 1 – A normal healthy patient, ASA 2 – A patient with mild systemic disease).
排除标准
- •Patients undergoing emergency surgeries.
- •Pregnant women
- •Patients with uncontrolled hypertension
- •Cardiovascular and cerebrovascular disease
- •Known allergy to study drug
- •Anticipated difficult intubation.
- •Patients on beta blockers.
结局指标
主要结局
To compare the efficacy of bolus dose of remifentanil (2μg/kg) and bolus dose of fentanyl (2μg/kg) in attenuating heart rate response to laryngoscopy and intubation in patients undergoing General Anesthesia.
时间窗: The hemodynamic parameters like heart rate , systolic blood pressure , diastolic blood pressure , mean arterial pressure will be measured and recorded at 0, 1 , 2 , 3, 4, 5 minutes and every 5 minutes for the next 30 minutes and every 15 minutes thereafter till the end of surgery
次要结局
- To compare the incidence of complications (bradycardia, hypotension, hypertension) between both the groups(Patient’s hemodynamic parameters like Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure will be checked every minute for the initial 5minutes and every 5 minutes for next 30 minutes and every 15 minutes thereafter till the end of surgery.)
研究者
Dr D Merlin Lydia
Pondicherry Institute of Medical Sciences