跳至主要内容
临床试验/CTRI/2011/06/001786
CTRI/2011/06/001786招募中不适用

A comparative study to see the efficacy of intranasal dexmeditomedine versus oral alprazolam as a premedication agent in morbid obese patients undergoing bariatric surgery

未提供1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年3月21日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Sedation as per RAmsay sedation score

研究概览

简要总结

Morbidly obese patients are candidates who are challenges for anaesthesiologists as they are associated with multiple comorbidities like obstructive sleep apnoea, difficult airway and difficult venous cannulations.etc. In view of their tendency to desaturation, sedative premedication should be used with great caution. The common antianxiety agent used is oral midazolam. Dexmeditomedine ,anDexmeditomedine, an alpha2 agonist is a newer drug, has unique propertiesunique properties including sedationincluding sedation, anxiolytic and analgesia with the unique characteristic of absence of respiratory depression. The sympatholytic and antinocciceptive properties of dexmeditomedine adds to the hemodynamic stability apart from preservation of airway reflexes . The sedation produced by dexmeditomedine has unique properties that it produces an unusually co-operative form and unique form of sedation in which the patient is calmly and easily aroused from sleep to wakefulness to allow task performance and excellent communication and can go back to sleep when not stimulated unlike other sedatives. The only other drug with similar pharmacological properties is clonidine. But the sedation and respiratory depression associated with clonidine makes it anit an unpopular option for premedication in this group of patients. Dexmedetomedine has found a definite place in the intraoperative management of morbid obese patients undergoing bariatric or non-bariatric procedures. The definitive role of Dexmeditomedine as a premedication in morbid obese patients undergoing bariatric and non-bariatric procedures has not been studied. The various modes of administration of Dexmeditomedine are by intravenous, intramuscular and intranasal methods. Intranasal method is a non-invasive method of drug administration where the drug is absorbed well by the vascular nasal mucosa and produces its effect rapidly within 20 minutes .The intranasal route also bypasses the first pass metabolism. Usually the intranasal method has been used in children undergoing various procedures. We will undertake a pilot study and study the efficacy of this drug as compared to midazolam on the effects of sedation and the hemodynamic response to laryngoscopy and tracheal intubation in morbid obese patients with OSA.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.BMI 35 2.Hemodynamically stable.

排除标准

  • 1.Refusal to give consent 2.Known allergy to alpha2 agonists3.Patients on psychotropic drugs4.Recent cardiac events like coronary stenting, acute myocardial infarction5.Mentally deranged patient.

结局指标

主要结局

Sedation as per RAmsay sedation score

时间窗: after 45 minutes

次要结局

  • Heart rate ,Mean arterial pressure Saturation of oxygen(BAseline)

研究者

发起方
未提供

研究点 (1)

Loading locations...

相似试验