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临床试验/CTRI/2019/08/020785
CTRI/2019/08/020785已完成不适用

comparison of effect of magnesium sulphate nebulization and ketamine nebulization in prevention of postoperative sore throat

Department of Anesthesia1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2017年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
111
试验地点
1
主要终点
Change in the incidence and severity of Postoperative sore throat by preoperative nebulization of Magnesium sulphate 300mg or Ketamine 50mg

研究概览

简要总结

A Prospective randomized double blind study titled “Comparison of effect of Magnesium

Sulphate Nebulization and Ketamine nebulization in prevention of postoperative Sore throatâ€

was undertaken at M.S.Ramaiah Hospitals, Bangalore. The study was conducted on 111

patients belonging to ASA 1, 2 and 3 undergoing elective surgery under general anaesthesia

with tracheal intubation. Study subjects were divided into three study groups. Patients in

Group M were nebulized with 3ml (300mg) of Magnesium Sulphate, Group K with 3ml

(50mg) of Ketamine and Group S with 3ml Normal Saline. Nebulization was administered

15minutes prior to the surgery and general anaesthesia was induced 5minutes after

Nebulization. Hemodynamic monitoring was done pre nebulization, post nebulization and

post induction. Postoperatively patients were assessed for incidence and severity of POST,

hoarseness of voice, dysphagia and cough at intervals of 0, 2, 4, 12 and 24 hours

postoperatively.

The incidence of POST was significantly less in Group M (13.5%) and Group K (2.7%) when

compared to Group S (94.6%). There was also significant reduction in the incidence and

severity of Postoperative hoarseness, dysphagia and cough at 0, 2 and 4 hours in Group M

and Group K when compared to Group S.

Thus it can be concluded that Preoperative Nebulization with Magnesium sulphate 300mg or

Ketamine 50mg is an effective method for preventing Postoperative Sore throat,

hoarseness, dysphagia and cough in patients undergoing elective surgery under General

anaesthesia with tracheal intubation.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor 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

  • •Patients giving informed written consent
  • •ASA physical status I-III.
  • •Malampati Grade I-II.
  • •Patients scheduled for elective surgery under GA with Tracheal intubation.

排除标准

  • •Surgical procedures of >2hours(H) duration & ENT surgeries on the adenoids, Tonsils & Ear and Intra-Oral surgeries.
  • •Prone positions or steep trendelenberg or Anti-Trendelenberg Position.
  • •H/o URTI in the previous 2 weeks.
  • •H/o Smoking .
  • •H/o reactive airway disease & already on bronchodilator nebulization.
  • •Endotracheal (ET) Tube cuff pressure >25 cmH2O in order to obtain airtight seal.
  • •H/o allergy to MgSo4 and /or Ketamine.
  • •More than 2 attempts at laryngoscopy & intubation.
  • •Procedures necessitating Nasogastric tube insertion.
  • •Laproscopic procedures (prolonged) involving higher airway pressures of >30cmH2O.

结局指标

主要结局

Change in the incidence and severity of Postoperative sore throat by preoperative nebulization of Magnesium sulphate 300mg or Ketamine 50mg

时间窗: Postoperatively at 0 2 4 12 and 24 hours

次要结局

  • Change in the incidence & severity of(Postoperative Dysphagia .)

研究者

申办方类型
Private medical college

研究点 (1)

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