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临床试验/CTRI/2024/07/069966
CTRI/2024/07/069966已完成不适用

Analysis of Postoperative Sore Throat Incidence Among Patients Undergoing Various Surgeries Under General Anaesthesia: A Prospective Observational Study

Ankitha1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2024年7月4日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
93
试验地点
1
主要终点
To evaluate the expected occurrence and severity of sore throat and assessment of hoarseness among patients undergoing surgeries through endotracheal intubation

研究概览

简要总结

In this study "ANALYSIS OF POSTOPERATIVE SORE THROAT INCIDENCE AMONG PATIENTS UNDERGOING VARIOUS SURGERIES UNDER GENERAL ANAESTHESIA: A PROSPECTIVE OBSERVATIONAL STUDY” is a prospective observational study aims to explore the occurrence of post-operative sore throat (POST) and hoarseness in patients undergoing various surgeries under general anaesthesia. The primary objective of the study is to evaluate the incidence and severity of sore throat and hoarseness with secondary objectives, the influence of gender on outcomes.

The study design will incorporate an observational study, which will include all patients   undergoing elective surgery under general anaesthesia. Written Informed consent will be obtained from all participants.

The anaesthesia protocol will adhere to standard practices. Monitoring will encompass standard parameters, and airway management equipment will vary based on the type of surgery. Follow- up assessments will be conducted in the post-anaesthesia care unit (PACU) and 12 hours post- extubation. POST and hoarseness will be assessed using standardized scales.

Data will be collected at three time points, including 1st hour, 6th hour, and 12th hour postoperatively.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Male and female participants aged between 18 and 60years Mallampati score I & II (Airway assessment to assess the mouth opening) American Society of Anaesthesiologists (ASA) Physical status I & II Participants scheduled for elective surgery under general anaesthesia e.
  • Those who were to remain in the hospital for at least 24 hours postoperatively.

排除标准

  • Participants posted for emergency surgeries Failure to ETT insertion and estimated surgical time lasts for more than 6 hours Anticipated difficult airway History of perioperative sore throat.

结局指标

主要结局

To evaluate the expected occurrence and severity of sore throat and assessment of hoarseness among patients undergoing surgeries through endotracheal intubation

时间窗: Postoperative Sore Throat and Hoarseness will be assessed by using a standard 4 point scale at three time points(after 1 hour, after 6 hours and after 12 hours postoperatively) [5-6min]

次要结局

  • To assess potential factors such as gender and size of endotracheal tube among patients undergoing surgeries through endotracheal intubation(Endotracheal Intubation will be done by the anaesthesiologist and Postoperative Sore Throat and Hoarseness will be assessed by using a standard 4 point scale at three time points(after 1 hour, after 6 hours and after 12 hours postoperatively) to assess the factors such as gender and type of endotracheal tube)

研究者

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

Ankitha

Yenepoya School of Allied Health Sciences Yenepoya (Deemed to be University)

研究点 (1)

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