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临床试验/CTRI/2024/01/061251
CTRI/2024/01/061251尚未招募3 期

To Compare the Efficacy Of Oral Magnesium And Zinc In Decreasing The Incidence Of Post Operative Sorethroat In Thyroid And Parathyroid Surgeries.

Fluid Research Grant CMC Vellore1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2024年2月1日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
105
试验地点
1
主要终点
To compare the effectiveness of magnesium and zinc syrup in reducing the incidence of Post operative sorethroat at four time intervals 1 hour,4 hour, 12 hour,24 hour after extubation in thyroid and parathyroid surgeries.There is no separate secondary outcome for our study.

研究概览

简要总结

A prevalent complication following orotracheal intubation in patients undergoing general anaesthesia is postoperative sore throat. This is due to the mechanical trauma produced by tracheal intubation, as well as the mucosal irritation, inflammation, and edema caused by endotracheal tube cuff pressure. The goal of this study is to evaluate the effectiveness of oral magnesium and zinc in preventing this complication. These medications have anti-nociception, anti-inflammatory, tissue- healing, and tissue-repair properties. It will be a prospective, randomised, double-blind, placebo- controlled study. Participants will be chosen according to the inclusion criteria after receiving their written consent. Using a computer-generated randomization system, a sealed and coded envelope containing oral zinc, magnesium, or a placebo will be distributed. The code will be kept until the conclusion of the investigation.The dose of Zinc sulphate to be used in this study will be 5mg and Magnesium sulphate will be 10 mg.Placebo will be a sucrose solution matching the same taste,colour, and consistency of Zinc and Magnesium syrups. The patient will be instructed to consume the medication 30 minutes before anaesthesia induction. Standard American Society of Anaesthesiologists monitors will be employed in the operating room. After adequate preoxygenation, the patient will be induced with 2mcg/kg of Fentanyl and 2mg/kg of Propofol, followed by orotracheal intubation after neuromuscular blockade has been achieved with 0.5mg/kg of Atracurium. The anesthesiologist will perform laryngoscopy using Macintosh blades 3 or 4, documenting Grades according to the Cormack and Lehane classification, number of attempts, duration of orotracheal intubation, and/or any complications that may have occurred during the procedure. An appropriate sized endotracheal tube according to the patients gender,weight and age will be used and will be standardizing the cuff pressure to 20-25 cm of H2O in all cases.We will be using ETT size of 6.5/7 for female patients and 7/7.5 for male patients. All intubations will be done by Second year post graduades and above. Isoflurane and intermittent doses of atracurium will be used to maintain anaesthesia. Every 30 minutes, the cuff pressure will be measured and maintained between 20 and 25 cm H2O. During surgery, the use of nonsteroidal anti-inflammatory medications and steroids will be documented. Anesthesiologists will perform oropharyngeal suctioning and then do awake extubation of the patient. On arrival in the recovery room, the patient’s severity of sore throat will be assessed using a standardized four-point pain scale. This assessment is a verbal questionnaire which will be taken at four different time intervals ie 1 hour,4 hour,12 hour,24 hour following extubation.Point 0 indicates no sore throat, 1 indicates a mild sore throat (complains only when questioned), 2 indicates a moderate sore throat (complains even when not questioned), and 3 indicates a severe sore throat (presence of hoarseness or voice change). Anybody with POST score of 3 or more will be treated with NSAIDS like Paracetamol and dexamethasone.They will not be excluded from the study.There will be a record of any adverse effects, such as vomiting, vertigo, metallic taste, or diarrhoea.

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 60.00 Year(s)(—)
性别
All

入选标准

  • •Patients in the age group between 18 to 60 years
  • •Patients belonging to American Society of Anesthesiologists Physical Status(ASA-PS) classification 1 and 2
  • •Patients undergoing elective thyroid and parathyroid surgeries lasting for 1 to 6 hours
  • •Mallampatti grade 1 and 2.

排除标准

  • •Mallampati grade of more than 2
  • •More than two attempts at intubation
  • •History of preoperative sore throat, upper respiratory tract infection
  • •common cold or smoking
  • •History of allergy to magnesium or zinc
  • •Patients receiving chronic treatment of NSAIDs, steroids or magnesium
  • •Difficult airway 8.

结局指标

主要结局

To compare the effectiveness of magnesium and zinc syrup in reducing the incidence of Post operative sorethroat at four time intervals 1 hour,4 hour, 12 hour,24 hour after extubation in thyroid and parathyroid surgeries.There is no separate secondary outcome for our study.

时间窗: four time intervals 1 hour,4 hour, 12 hour,24 hours from the time of extubation in thyroid and parathyroid surgeries

次要结局

  • To compare the effectiveness of magnesium and zinc syrup in reducing the incidence of Post operative sorethroat at four time intervals 1 hour,4 hour, 12 hour,24 hour after extubation in thyroid and parathyroid surgeries.(four time intervals 1 hour,4 hour, 12 hour,24 hours from the time of extubation in thyroid and parathyroid surgeries)

研究者

发起方
Fluid Research Grant CMC Vellore
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Jeenu Ann Jose

Christian Medical College, Vellore

研究点 (1)

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