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临床试验/NCT07256834
NCT07256834尚未招募1 期

Incidence of Sore Throat in Postoperative Patients After Use of Betamethasone Gel Compared With Lidocaine Gel During Endotracheal Intubation

Jinnah Postgraduate Medical Centre0 个研究点目标入组 60 人开始时间: 2025年11月22日最近更新:
干预措施

试验速览

阶段
1 期
状态
尚未招募
入组人数
60
主要终点
Post operative sore throat

研究概览

简要总结

The goal of this clinical trial is to compare the incidence of postoperative sore throat in adult patients of either gender belonging to ASA I or II ,undergoing endotracheal intubation using betamethasone gel versus lidocaine gel. It aims to determine

1: Difference in efficacy of Betamethasone gel and lidocaine gel in prevention of post operative sore throat after endotracheal intubation.

Patients will be assessed for the presence of a sore throat at 6 hours and 24 hours postoperatively. The severity of the sore throat will be graded using the Post-Operative Sore Throat (POST) score.

详细描述

This study aims to resolve the debate over the superiority of betamethasone versus lidocaine in preventing POST. Achieving clarity on this issue will not only reduce patient morbidity but also help decrease the duration of hospital stays and lower hospital bed occupancy.The study will commence following the approval of the synopsis by the Research Department of the College of Physicians and Surgeons, Pakistan (CPSP). All patients scheduled for elective surgery under general anesthesia who fulfil the inclusion criteria will be included in the study from Jinnah Postgraduate Medical Center (JPMC). Informed written consent will be obtained from the patients prior to their inclusion in the study.

Initial data, including name, date of presentation, age, weight, height, BMI and gender will be recorded on a predesigned proforma. Patients will then be divided into two group (A and B) through simple random sampling software. In Group A patients, before induction of anesthesia, endotracheal tube will be lubricated with 2.5ml of 0.05% Betamethasone dipropionate gel, from distal end of cuff to 15cm mark on endotracheal tube. In Group B patients, lubrication will be done in a similar manner using 2.5ml of 2% Lidocaine gel. After induction of anesthesia (with IV Propofol 2.5mg/kg, Nalbuphine 0.1mg/kg, Atracurium 0.5mg/kg) and 3 minutes of bag mask ventilation, trachea will be intubated with endotracheal tube of size 7 or 7.5mm according to internal diameter of trachea. Successful endotracheal intubation will be confirmed by capnography and bilaterally equal air entry. Maintenance of general anesthesia will be done by Isoflurane and 60% oxygen mixed with compressed air. Upon completion of surgery, Isoflurane will be discontinued, and residual neuromuscular blockage will be antagonized by Neostigmine 0.05mg/kg. The trachea will be extubated after the patient is fully awake. All patients will be shifted to post-anesthesia care unit where standard ASA monitoring will be continued by a team of anesthetists. The presence and grading of Postoperative sore throat will be done by researcher himself, according to POST Scores at 6 and 24 hours postoperatively, in presence of consultant anesthetist of 5 years of experience. The study will be relevant and specific towards its objective and proper exclusion criteria will be used to control any bias / confounders.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-60 years
  • Either gender
  • ASA I to II
  • Patients planned for elective surgery under general anesthesia not lasting more than 4 hours.

排除标准

  • Patients requiring more than 2 attempts for successful intubation
  • Patients undergoing surgeries of oral cavity or pharynx
  • Mallampati Score of 3 or 4
  • Patients with upper respiratory tract infection
  • Patients already taking steroids
  • Use of nasogastric tube perioperatively

研究组 & 干预措施

Group A receiving betamethasone gel during endotracheal intubation

Active Comparator

Group A patients, before induction of anesthesia, endotracheal tube will be lubricated with 2.5ml of 0.05% Betamethasone dipropionate gel, from distal end of cuff to 15cm mark on endotracheal tube

干预措施: Betamethasone dipropionate 0.05% (Drug)

Group B receiving lidocaine gel during endotracheal intubation

Active Comparator

Group B patients, before induction of anesthesia, endotracheal tube will be lubricated with 2.5ml of 2% Lidocaine gel, from distal end of cuff to 15cm mark on endotracheal tube

干预措施: Lidocaine hydrochloride 2% (Drug)

结局指标

主要结局

Post operative sore throat

时间窗: Sore throat after endotracheal intubation at 6 hrs and 24hrs post operatively. Sample completion in 2 weeks

Comparing presence and grading of sore throat in both arms after endotracheal intubation.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

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