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临床试验/CTRI/2023/10/059186
CTRI/2023/10/059186尚未招募4 期

"Comparison of effectiveness of two different doses of nebulized dexmedetomidine with lignocaine for awake fibreoptic intubation in patients under general anaesthesia: A randomized double-blinded controlled study"

Rabindranath Tagore Medical College1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2023年6月11日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
96
试验地点
1
主要终点
Cough severity score during awake fiber optic intubation

研究概览

简要总结

Among the various methods to facilitate AFOI, topical anaesthesia with LA (lignocaine) nebulisation is a commonly used technique. However, topical anaesthesia with lignocaine alone may be inadequate in some patients.

Dexmedetomidine, a selective alpha- 2 adrenergic agonist, that provides both analgesia and sedation without causing respiratory depression.    Only two studies have been done where this combination (dexmedetomidine in a dose of 0.6 µg/kg  and 1 µg/kg)   has been   used for flexible fiberoptic bronchoscopy Till date.We hypothesised that combination of nebulised dexmedetomidine-lidocaine could reduce the incidence of moderate to severe coughing during AFOI

With more intubation comfort, better post-intubation tolerance and patient satisfaction along with adequate sedation and stable haemodynamics.The present study has been planned with an aim of comparing the effectiveness of two different doses of nebulised dexmedetomidine with lignocaine for AFOI in patients undergoing surgery under general anaesthesia.

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 50.00 Year(s)(—)
性别
All

入选标准

  • 2.Patients with American Society of Anesthesiologists (ASA) Physical Status (PS) I and II 3.Patients with Mallampati Class I and II.

排除标准

  • Patients who have not given consent.
  • 2.Patients with age <18 and >50 years
  • Patients with ASA PS III and IV and Mallampati class III and IV
  • Patients with BMI >35 kg/m2.

结局指标

主要结局

Cough severity score during awake fiber optic intubation

时间窗: During awake fiber optic intubation (2 minutes)

次要结局

  • Intubation comfort score(Post intubation behavior score/Assessment)

研究者

发起方
Rabindranath Tagore Medical College
申办方类型
Government medical college

研究点 (1)

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