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临床试验/CTRI/2025/11/097163
CTRI/2025/11/097163尚未招募不适用

Comparison of proportion of post operative sore throat following endotracheal intubation between videolaryngoscope and macintosh blades in patients undergoing general anaethesia.

Kasturba Medical College, Mangalore2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
2
主要终点
Post-operative sore throat and pain

研究概览

简要总结

Post operative sore throat (POST) is a frequent and discomforting complaint after general anaesthesia involving endotracheal intubation. Its incidence ranges between 14-62% largely due to mucosal irritation, pressure trauma and mechanical injury during laryngoscope (MCL) requires greater lifting force and neck manipulation, which may increase mucosal trauma. In contrast, videolaryngoscopes (VLs) provide an improved glottic view with minimal force and less airway manipula adadvantagetion. However, literature reveals conflicting results regarding whether VLs actually reduce the incidence of POST compared to MCLs.

The present study aims to compare the proportion of POST between patients intubated with a videolaryngoscope and those intubated with a Macintosh blade. All participants will undergo standard pre-anaesthetic evalution, induction and intubation using either a VL or MCL as per group allocation. Post operative sore throat will be assessed at 0,1,6 and 12hrs after extubation using a stuructured proforma. Ethical principals of confidentiality, voluntary participation, and informed consent will be maintained throughout. No additional budget is required as all necessary equipment is available within the institution.

in conclusion, this study seeks to establish whether videolaryngoscopy offers a significant advantage over the Macintosh technique in reducing the frequency and severity of post-operative sore thraot, thereby enhancing patient comfort and improving airway management practices in anaesthetic care.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Aged between 18-65 years of both genders.
  • Elective surgery under general anesthesia.
  • American society of anaesthesiologists I-II patients.
  • Mallampatti grade of I and II.
  • BMI less than 30 kg/m2.

排除标准

  • Patient refusal.
  • Pregnant patients.
  • Emergency surgery.
  • Bariatric, cardiac, nasal, oral, head and neck surgeries.
  • Surgeries requiring throat pack or nasogastric tube or orogastric tube.
  • Surgeries requiring Rapid sequence intubation.
  • Patients with history of URTI.
  • Patients with pre operative hoarseness or sore throat.
  • Anticipated difficult airway.
  • Patients with psychiatric diagnosis.
  • Patients on any steroid medications or NSAIDs medication within one week of surgery.

结局指标

主要结局

Post-operative sore throat and pain

时间窗: 0hr, 1hr, 6hr, 12hr post operatively

次要结局

  • Number of attempts taken to intubate.(Baseline)
  • Complications like upper lip trauma, damage to teeth, possible airway trauma, & laryngospasm.(Baseline)
  • Time required to intubate(Baseline)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

JADHAV MRUNAL SANJIV

Kasturba Medical College, Mangalore

研究点 (2)

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