跳至主要内容
临床试验/CTRI/2020/03/023933
CTRI/2020/03/023933尚未招募不适用

Comparison of oral Pregabalin with Clonidine for attenuating pressor response to direct Laryngoscopy in patients undergoing thyroidectomy-A randomised controlled trial

MOSC Medical College Kolenchery1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年3月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare oral Pregabalin with Clonidine in blunting the pressor response to direct laryngoscopy and endotracheal intubation by monitoring the changes in heart rate and blood pressure

研究概览

简要总结

Direct laryngoscopy and tracheal intubation are employed as gold standard for conduct of safe general anaesthesia for thyroidectomy  surgeries. But both these procedures are noxious stimuli leading to hemodynamic fluctuations , higher myocardial oxygen demend , increased catecholamines and cardiac arrythmias. This is a concern in all patients particularly in cardiac and cerebrovascular diseases. Several techniques are employed to prevent the hemodynamic responses following laryngoscopy and intubation such as deepening the plain of anesthesia,use of vasodilators, lignocaine, betablockers calcium channel blockers and opiods. All these agents have various side effects.if no specific measures are taken , heart rate can increase from 26 to 66 percentage depending on the method of intubation and systemic blood pressure can increase from 36 to 45 percentage which maybe due to variation in balance between sympathetic and parasympathetic outflow or receptor hypersensitivity. Clonidine posses several properties to make it a valuable premedicant to attenuate the hemodynamic response of laryngoscopy and tracheal intubation. Pregabalin is a voltage gated calcium channel inhibitor with analgesic , anxiolytic and anticonvulsant properties making it a useful oral premedicant. Hence,we are conducting the present double blinded , randomised controlled trial to evaluate the effectiveness of oral pregabalin to clonidine in attenuating hemodynamic changes during direct laryngoscopy and tracheal intubation.

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研究设计

研究类型
Interventional
分配方式
Computer generated randomization
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

  • ASA I AND II PATIENTS WITH BMI 18 TO 30 UNDERGOING THYROIDECTOMY UNDER GENERAL ANESTHESIA.

排除标准

  • KNOWN ALLERGY TO STUDY DRUGS THYROID WITH RETROSTERNAL EXTENSION PATIENT REFUSAL FOR PARTICIPATION IN THE STUDY PATIENTS ON LONG TERM TREATMENT WITH ANALGESICS SEDATIVES BETA BLOCKERS AND ANTICONVULSANTS PREGNANT WOMEN.

结局指标

主要结局

To compare oral Pregabalin with Clonidine in blunting the pressor response to direct laryngoscopy and endotracheal intubation by monitoring the changes in heart rate and blood pressure

时间窗: 1;3;5;7;10 minutes after intubation

次要结局

  • To assess the effect of oral pregabalin and clonidine on preoperative anxiety and sedation using standard scoring systems.
  • To evaluate the intra operative hemodynamic profile by monitoring heart rate, blood pressure and postoperative analgesia(30 minutes interval for 6 hours after surgery)

研究者

发起方
MOSC Medical College Kolenchery
申办方类型
Private medical college

研究点 (1)

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