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临床试验/CTRI/2025/12/099825
CTRI/2025/12/099825尚未招募2/3 期

Comparison of Endotracheal Tube Cuff Inflation Between Dexmedetomidine, 2% Lignocaine and Air on Quality of Extubation: A Prospective Randomised Controlled Study.

Dr Hema Shubha Yadlapalli1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2025年12月30日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
93
试验地点
1

研究概览

简要总结

Oral endotracheal intubation is a routine and indispensable component of general anesthesia management for surgical procedures. Cuffed tubes are preferred to uncuffed tubes as the inflated cuff offers a seal between the cuff and the trachea and enable positive pressure ventilation and prevent aspiration. The cuff pressure stimulates the stretch receptors in the tracheal mucosa causing  uncontrollable  postop cough and airway morbidities of sore throat, hoarseness, and dysphagia. Recently,  intracuff route is proven to be more efficacious  with prolonged duration than topical  route due to slow absorption into trachea bronchial mucosa. Dexmedetomidine , a novel  drug  is lipid soluble and has selective alpha 2 adrenergic agonistic action.It has gained popularity for its sedative and analgesic properties, and its potential anti-inflammatory effects. Regarding dexmedetomidine only topical and iv route trials have been conducted. There is still a lack of consensus in the literature regarding the  practice of  dexmedetomidine as intracuff route. Hence, we designed this study to evaluate intracuff dexmedetomidine with lignocaine on airway morbidities and haemodynamics  in patients under general anaesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • Written and valid informed consent.
  • Estimated duration of surgery more than 60 min and less than 300 min.
  • ASA classes I and II Body mass index (BMI) less than 30 kg/m
  • Elective surgeries.

排除标准

  • Patient refusal ASA classes III and IV Chronic smokers laryngotracheal diseases/surgery Known allergy to study agents COPD, asthma, history of recent upper respiratory tract infection Requiring insertion of nasogastric tube Oro-pharyngeal airway introduced preoperatively Multiple intubation attempts Raised intracranial pressure, intraocular pressure History of gastric regurgitation Requiring rapid sequence induction Anticipated difficult airway Undergoing laparoscopic surgeries.

研究者

发起方
Dr Hema Shubha Yadlapalli
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DrHema Shubha Yadlapalli

Nizam’s Institute of Medical Sciences

研究点 (1)

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