A COMPARATIVE EVALUATION OF NEBULISED FENTANYL, DEXMEDETOMIDINE, AND MAGNESIUM SULPHATE IN MODULATING HAEMODYNAMIC STRESS RESPONSE DURING LARYNGOSCOPY AND TRACHEAL INTUBATION: AN OPEN LABLE, RANDOMIZED, THREE WAY STUDY
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- To assess the change in heart rate (HR) from the baseline (before nebulisation) to two minutes after tracheal intubation following administration of nebulised fentanyl, dexmedetomidine, or magnesium sulphate.
研究概览
简要总结
This double-blinded, randomised comparative study evaluated the effectiveness of nebulised fentanyl, dexmedetomidine, and magnesium sulphate in attenuating the haemodynamic (pressor) response to laryngoscopy and tracheal intubation. Ninety ASA I–II adult patients undergoing elective surgery were randomised into three groups to receive nebulisation with fentanyl 1 µg/kg, dexmedetomidine 1 µg/kg, or magnesium sulphate 40 mg/kg prior to induction of anaesthesia. Heart rate (HR), systolic, diastolic and mean arterial blood pressure (SBP, DBP, MAP) were recorded at baseline, post-nebulisation, and at 2, 5 and 10 minutes after intubation.
The study found that dexmedetomidine and magnesium sulphate were superior to fentanyl in blunting the pressor response. An increase in HR after intubation was observed only in the fentanyl group, whereas HR remained at or below baseline in the dexmedetomidine and magnesium groups. All three groups showed a decreasing trend in SBP, DBP and MAP, but the reductions were more consistent and statistically significant with dexmedetomidine and magnesium. Adverse effects were minimal, with only occasional hypotension in the magnesium group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients aged between 18 and 60 years scheduled for elective surgeries requiring endotracheal intubation under general anaesthesia.
- •Classified as American Society of Anesthesiologists (ASA) physical status I or II.
- •Patients with Mallampati airway classification Grade I or II.
排除标准
- •Patients with known drug allergies to study drugs,
- •Individuals with a body mass index (BMI) greater than 30 kg/m²,
- •History of severe cardiovascular diseases (such as ischaemic heart disease or uncontrolled hypertension),
- •Patients with a history of alcohol intake or chronic drug use,
- •Pregnant women
- •Cases where tracheal intubation time exceeded 20 seconds.
结局指标
主要结局
To assess the change in heart rate (HR) from the baseline (before nebulisation) to two minutes after tracheal intubation following administration of nebulised fentanyl, dexmedetomidine, or magnesium sulphate.
时间窗: before nebulization to 2 minutes post intubation
次要结局
- To analyse variations in(Systolic Blood Pressure (SBP),)
研究者
Dr CHARAN L
SHRI B.M PATIL MEDICAL COLLEGE AND HOSPITAL