A randomized, double blinded, placebo controlled clinical trial to evaluate the efficacy of intranasal Dexmedetomidine as premedicant to attenuate haemodynamic response of laryngoscopy and intubation in elective lumber spine surgery.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Sedation and preoperative reduction in anxiety.
研究概览
简要总结
This study is a randomized, double blinded placebo controlled trial comparing the safety and efficacy of Intranasal Dexmedetomidine (1 mcg/kg body weight) with Oral Daizepam (0.2 mg/kg body weight) versus intranasal placebo with Oral Diazepam ( 0.2 mg/kg body weight) only, in 70 adult patients undergoing elective lumbar spine surgery in 1 centre in India.
The primary outcome measures are:
-
Preoperative reduction in anxiety and preoperative sedation, measured upto 45 minutes prior to induction of anaesthesia.
-
Hemodynamic response measured by Heart Rate and Blood pressure variation to laryngoscopy and endotracheal intubation measured upto 10 mins after intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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
- •Patients with ASA physical status I, patients having Mallampati I and II, patients with body mass index (BMI) < 30 kg/m2.
排除标准
- •Patients refusal to participate in the study.Known allergy or hypersensitive reaction to dexmedetomidine or diazepam.
- •Patients suffering from significant cardiac disease e.g IHD, cardiomyopathy, valvular disorder, hypertension, arrhythmia, etc.
- •Patients suffering from significant respiratory disease e.g COPD, bronchial asthma, interstitial lung diseases, pneumonia etc.
- •Patients having metabolic, endocrinal, musculoskeletal, neurologic disorder or having major congenital anomalies.
- •History of drug abuse and/or psychiatric disorder.
- •Pregnant women; no reliable contraceptive measures in postmenopausal women.
- •Patients taking antihypertensive drugs such as methyldopa, clonidine and other α2 receptor agonists.
- •Patients having morbid obesity, obstructive sleep apnoea, suspected difficult airway.
- •Patients having liver and kidney dysfunction.
- •Patients having long-term use of sedatives and analgesics.
结局指标
主要结局
Sedation and preoperative reduction in anxiety.
时间窗: Sedation and anxiety upto 45 mins before induction of General anaesthesia, hemodynamic variation from preinduction upto 10 mins after endotracheal intubation.
Heart Rate (variation of 10 beats/min) and Blood pressure variation to laryngoscopy and endotracheal intubation.
时间窗: Sedation and anxiety upto 45 mins before induction of General anaesthesia, hemodynamic variation from preinduction upto 10 mins after endotracheal intubation.
次要结局
- Any side effects including bradycardia and hypotension.(during the whole study period.)