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临床试验/CTRI/2025/07/090543
CTRI/2025/07/090543尚未招募4 期

Comparison Between Incidence of Post Operative Sore Throat with Conventional Intubation and 180 Degree Rotation of Endotracheal Tube During Intubation in Adult Patient Under General Anaesthesia

未提供1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年7月25日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
250
试验地点
1
主要终点
Incidence of postoperative sore throat assess by sore throat grading

研究概览

简要总结

GROUP C , patients intubated by conventional method of intubation.

GROUP R , patients intubated by 180 degree rotation of endotracheal tube during intubation.

After shifting the patient to the operating room, patient will be placed in supine position and

standard monitors will be attached including heart rate , electrocardiogram , non

invasive blood pressure monitor and pulse oximetry. Pre-oxygenation will be done

with 100 percent Oxygen for 3 minutes. Induction will be done with inj. midazolam 1mg, inj.

propofol 2 mg per kg , inj. fentanyl 2 mcg per kg, inj. vecuronium 0.1mg per kg intravenously.

Appropriate size of endotracheal tube will be chosen according to the age of the patient.

Patient will be placed in the supine position with the head in sniffing position to facilitate

optimal alignment of the oral pharyngeal and laryngeal axis. After achieving adequate depth of anaesthesia and ensuring jaw relaxation, the endotracheal tube inserted using MacIntosh

laryngoscope by conventional method and 180 degree clockwise rotation of endotracheal

tube when tip of endotracheal tube just enters in glottis. Correct positioning will be confirmed

by observing bilateral chest movement, five point auscultation of breath sounds and the

presence of a square wave capnography. The patient will be ventilated using oxygen plus nitrous

oxide or Air plus sevoflurane until MAC 0.8 to 1.2 is achieved. Further course of anaesthesia will

proceed as per standard protocols keeping in mind need of the patient,  and surgery.

At the end of the surgery, neuromuscular blockade will be reversed using intravenous

neostigmine 0.05mg per kg and glycopyrrolate 0.01mg per kg. After confirming adequate reversal of

neuromuscular blockade and return of spontaneous respiration, the endotracheal tube will be

removed once the patient is awake, obeying verbal commands and able to maintain a patent

airway. The patient will be then shifted to the post op recovery room. In cases where

endotracheal tube removal is not performed due to clinical or surgical reasons, the patient

will be excluded from the study to maintain consistency in outcome assessment.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

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 l-lll Patient undergoing general anaesthesia with an Endotracheal tube placement Age more than 18 years Ability to communicate pain in the postoperative period.

排除标准

  • Pre existing sore throat, upper respiratory tract infection or recent cold with in 2 weeks Pregnant women Surgery involving pharynx larynx and vocal cord More than one attempt of intubation History of lung disease Difficult airway.

结局指标

主要结局

Incidence of postoperative sore throat assess by sore throat grading

时间窗: At baseline

次要结局

  • Severity of postoperative sore throat at different time intervals after extubation(Assessment of Hemodynamic parameters HR, SBP, DBP,MAP after intubation)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Kundan Kumar Jangir

ABVIMS and Dr RML Hospital New Delhi

研究点 (1)

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