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临床试验/CTRI/2025/08/093742
CTRI/2025/08/093742尚未招募不适用

COMPARISON OF SEVERITY OF POST OPERATIVE SORE THROAT FOLLOWING LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION USING DIRECT MCINTOSH LARYNGOSCOPE VERSUS VIDEO LARYNGOSCOPE

Adesh University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年9月18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
80
试验地点
1
主要终点
To compare the severity of post operative throat pain (using a validated Visual Analogue Scale) following endotracheal intubation with direct Mcintosh laryngoscope versus video laryngoscope at multiple time points post-extubation (upto 24 hours)

研究概览

简要总结

Direct laryngoscopy (DL) using a Mcintosh blade has been considered as the gold standard for performing endotracheal intubation in adults worldwide.

While effective in most routine cases,it can lead to potential mucosal damage, edema, and subsequent throat discomfort (Jaensson et al., 2012) and autonomic (Sympathetic pressor) response.

Post-operative sore throat (POST) is recognized as one of the most common complications following endotracheal intubation, with reported incidence ranging from 21% to 65% following general anesthesia with endotracheal intubation (El-Boghdadly et al., 2016).

The benefits of VL in terms of improved glottic visualization, higher first-attempt success rates, and utility in difficult airway scenarios are well-established (Aziz et al., 2012).

Despite these established benefits, the impact of VL complications like POST and associated throat pain remains less well-defined.

This study aims to address these gaps in the literature by conducting a prospective, randomized, controlled trial comparing the severity of throat pain following endotracheal intubation using direct Mcintosh laryngoscope versus video laryngoscope in patients undergoing elective surgeries requiring general anesthesia with endotracheal intubation

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • American Society of Anaesthesiologists (ASA) physical status I-II Scheduled for elective surgery under general anaesthesia requiring endotracheal intubation Expected duration of surgery between 1-3 hours.

排除标准

  • History of recent upper respiratory tract infection (within 2 weeks) Pre-existing sore throat or hoarseness Previous neck surgery or radiation History of gastroesophageal reflux disease Patients requiring rapid sequence induction Surgery involving the oral cavity, pharynx, or larynx.

结局指标

主要结局

To compare the severity of post operative throat pain (using a validated Visual Analogue Scale) following endotracheal intubation with direct Mcintosh laryngoscope versus video laryngoscope at multiple time points post-extubation (upto 24 hours)

时间窗: Throat pain assessment using VAS (Visual Analogue Scale) at: | Immediately after extubation (once patient is fully awake) | 2 hours post-extubation | 6 hours post-extubation | 12 hours post-extubation | 24 hours post-extubation

次要结局

  • 1. To compare the severity of post-intubation sore throat using POST score with both laryngoscopy technique.(2. To determine the correlation between the degree of intubation difficulty using specifically devised & validated TEAG (Tongue, Epiglottis, Arytenoid tubercles, Glottis) score (to be validated) based on Cormack-Lehane grade & POGO score.)

研究者

发起方
Adesh University
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Anuraag kaur brar

Adesh Institute of Medical Sciences and Research

研究点 (1)

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