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临床试验/CTRI/2024/09/073844
CTRI/2024/09/073844已完成不适用

Comparative evaluation of aspirin and magnesium sulphate gargles for prevention of postoperative sore throat in patients undergoing lumbar laminectomy

Dayanand Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月23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
60
试验地点
1
主要终点
1.Incidence of sore throat.

研究概览

简要总结

Postoperative sore throat (POST) is a common complication afterendotracheal intubation. POST contributes to discomfort and morbidity for thepatient. POST is the result of local tissue trauma due to laryngoscopy and endotrachealintubation leading to the inflammation of the pharyngeal mucosa. Aspirin is acommonly used NSAID which acts by inhibiting the prostaglandin system. Aspiringargles have been observed to significantly reduce the incidence and severityof POST. Magnesium, an NMDA receptor antagonist in a few preliminary studieshas also been seen to reduce POST. However; definitive evidence on the role ofmagnesium sulphate gargles for the prevention of POST is lacking. Aim of thestudy is to compare the efficacy of gargles with aspirin and magnesium sulphatefor the prevention ofpostoperative sore throat in patients undergoing lumbar laminectomy in proneposition.  A prospective, randomized, double blindedstudy will be conducted on sixty patients of either sex between age group 18 to65 years belonging to ASA grade I, II and III scheduledfor elective lumbar laminectomy under general anaesthesia. Patients willbe randomly allocated to two groups –Group A and Group B of 30 patients each.Group A patients will receive gargle solution of tab Aspirin 325mg in 20ml of5% dextrose while group B patients will receive gargle solution of 2mlMagnesium sulphate in 20ml of 5% dextrose. In Post anesthesia care unit (PACU),patients will be evaluated for incidence and severity of sore throat usingNumerical Rating Scale (NRS) and severity grading scale at 1, 2, 4 and 24 hrspostoperatively. This study will aidelucidating the role of magnesium sulphate gargles for the prevention of POST.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
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

  • ASA I,II,III patients posted for elective lumbar laminectomy surgery in general anesthesia.

排除标准

  • Patient refusal.
  • Any known hypersenstivity or contraindication to aspirin, magnesium sulphate.
  • Recent H/O Sore throat.
  • Pregnant & lactating mothers.
  • Anticipated difficult intubation, MPS Grade III and IV.
  • Patients receiving chronic treatment with calcium channel blocking drugs or magnesium.
  • Patients on steroids due to any reason.
  • History of reactive airway disease like bronchial asthma or COPD, significant neurological or neuromuscular disorder.

结局指标

主要结局

1.Incidence of sore throat.

时间窗: At 1hour,2hour,4hour,12hour and 24hours

2.Severity of sore throat as assessed by NRS and subjective grading score.

时间窗: At 1hour,2hour,4hour,12hour and 24hours

次要结局

  • Incidence of post extubation cough(At 0hour,1hour,2hour,4hour,12hour and 24hour)

研究者

发起方
Dayanand Medical College and Hospital
申办方类型
Private medical college

研究点 (1)

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