A clinical trial to evaluate the effect preoperative intranasal Dexmedetomidine to decrease hypertensive response of laryngoscopy and endotracheal intubation in elective lumber spine surgery.
- Conditions
- Health Condition 1: null- 1. Preoperative anxiety and preoperative sedation.2. Hemodynamic response to laryngoscopic surge and endotracheal intubation
- Registration Number
- CTRI/2016/10/007384
- Lead Sponsor
- Bangur Institute of Neurosciences Kolkata
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
Patients with ASA physical status I, patients having Mallampati I and II, patients with body mass index (BMI) < 30 kg/m2.
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. Patients having Mallampati grades III and IV.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sedation and preoperative reduction in anxiety. <br/ ><br>Heart Rate (variation of 10 beats/min) and Blood pressure variation to laryngoscopy and endotracheal intubation.Timepoint: Sedation and anxiety upto 45 mins before induction of General anaesthesia, hemodynamic variation from preinduction upto 10 mins after endotracheal intubation.
- Secondary Outcome Measures
Name Time Method Any side effects including bradycardia and hypotension.Timepoint: during the whole study period.