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临床试验/CTRI/2025/01/078982
CTRI/2025/01/078982尚未招募Phase 3 4

Comparison of Preoperative ultrasound -guided Internal Branch Block of Superior Laryngeal Nerve with placebo on Postoperative Sore Throat caused by Double Lumen Endotracheal Intubation: A Randomized placebo control Trial

Dr Rishikesh1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2025年1月30日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
152
试验地点
1
主要终点
To measure incidence of sore throat within 24hrs of surgery

研究概览

简要总结

A total of 152 patients between 18-65 year of age  with either sex posted for thoracic surgery requiring DLT insertion and duration of surgery of 2-3 hours  will be randomly allocated into either group T or group C.

Group T will receive a USG-guided internal superior laryngeal nerve block with 2 ml ( 0.2%) ropivacaine after Intubation with DLT while Group C will intubated with DLT without block. primary outcome of study will incidence of Post operative sore throat(POST) at 24 hours and secondary outcome will be severity of POST at 0.5 ,2, 6 and 24 hours ,hemodynamics at regular tie point and any associated adverse effect seen with intervention.

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

  • All patients having age between 18-65 years with either sex, posted for thoracotomy requiring DLT insertion and duration of surgery of 2-3 hours will be performed USG guided internal superior laryngeal nerve block with 2 ml ( 0.2 %) ropivacaine after DLT insertion.

排除标准

  • patient will be excluded fro study are surgery performed in the neck, mouth, or throat area, recent or ongoing upper respiratory infection, and existing preoperative sore throat cases.

结局指标

主要结局

To measure incidence of sore throat within 24hrs of surgery

时间窗: To measure incidence of sore throat within 24hrs of surgery

次要结局

  • a)To assess severity of sore throat assessed at study time points (0.5, 2, 6 and 24 h)(b)To assess hemodynamic at regular time points)

研究者

发起方
Dr Rishikesh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Rishikesh

Indira Gandhi Institute of Medical Sciences, Patna

研究点 (1)

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