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临床试验/NCT03833947
NCT03833947已完成4 期

Comparision of Addition of Dexamethasone vs Bicarbonate to Intracuff Lignocaine 2% in Terms of Extubation Characteristics and Patient Satisfaction Undergoing General Anaesthesia

Aligarh Muslim University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
100
试验地点
1
主要终点
smoothness of extubation

研究概览

简要总结

This study is designed to evaluate and compare the effect on hemodynamics, extubation response and patients satisfaction score in patients with ETT cuff filled with either mixture of lignocaine with sodium bicarbonate or with a mixture of lignocaine with dexamethasone.

详细描述

Objective Recently multiple studies have shown better outcomes with usage of dexamethasone or alkalinized lignocaine instead of air for filling endotracheal tube (ETT) cuff. So this study is designed to evaluate and compare the effect on hemodynamics, extubation response and patients satisfaction score in patients with ETT cuff filled with either mixture of lignocaine with sodium bicarbonate or with a mixture of lignocaine with dexamethasone.

Design and setting:

This is a prospective single blind, randomized controlled study at the department of anesthesiology, JNMCH, AMU, Aligarh.

Materials and methods:

Investigators plan to include 100 patients of age group within 18-60 years with American Society of Anesthesiologists (ASA) class I & II, posted for elective surgery of duration >120 minutes, performed under general anesthesia; administered as per institutional protocols. Patients with ASA III & IV, cardiovascular morbidities, known drug allergy, pregnancy will be excluded from the study. Patients will be divided into two groups randomly according to chit-in-box method, viz Group A & Group D with fifty patients in each group. Patient group allocation, preparation of drug mixture for endotracheal cuff filling as per group assigned and analysis of observed data will be done by a separate anesthetist not involved in the perioperative management of the patient. In patients belonging to Group (A), ETT cuff will be filled with mixture of 7.5% sodium bicarbonate with 2% lignocaine in the proportions of 0.5: 9.5 ml while in Group D the ETT cuff will be filled with mixture of dexamethasone with 2% lignocaine in the proportions of 0.5: 9.5 ml . The cuff of the ETT will be slowly inflated until no leak is heard at all during the peak airway pressure of the ventilator cycle while auscultating the trachea . Volume of drug mixture in the cuff will be noted at start and end of surgery. Total duration of anesthesia will be noted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) class I & II.
  • Elective surgery
  • General anesthesia of duration >120 minutes.

排除标准

  • Patients with ASA III & IV.
  • Known Cardiovascular morbidities.
  • Pregnancy.
  • Allergic to used drugs.

研究组 & 干预措施

lignocaine with bicarbonate

Experimental

Endotracheal tube cuff was filled with mixture of 7.5% sodium bicarbonate with 2% lignocaine in a ratio of 0.5:9.5 ml

干预措施: lignocaine+bicarbonate (Drug)

lignocaine with dexamethasone

Active Comparator

Endotracheal tube cuff was filled with mixture of dexamethasone with 2% lignocaine in a ratio of 0.5:9.5 ml

干预措施: lignocaine+dexamethasone (Drug)

结局指标

主要结局

smoothness of extubation

时间窗: time from adequate reversal of anaesthesia & muscle paralysis (head holding >5sec, eye opening on command, train of four ratio >0.9) till removal of endotracheal tube.

Grade 1= coughing, bucking, tube biting, agitatation present. Grade 2= mild bucking/coughing. Grade 3= completely comfortable, tolerating tube in situ, no coughing/bucking/agitation.

patient satisfaction score

时间窗: post operative 1 hour

rated on visual analog scale varying 0 to 10; where 0 is worst experience and 10 is best. completely

次要结局

  • incidence of post operative cough and sore throat(after 1 and 24 hour post extubation)
  • Haemodynamic stability at the time of extubation.(values of product of systolic blood pressure and heart rate will be compared after stopping the anesthetic agents and immediately after the extubation)
  • amount of drug diffused through endotracheal tube cuff(from start till end of surgery.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

MUAZZAM HASAN

Assistant Professor, Department of Anaesthesiology

Aligarh Muslim University

研究点 (1)

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