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临床试验/CTRI/2024/12/077963
CTRI/2024/12/077963尚未招募不适用

A COMPARITIVE STUDY BETWEEN TOPICAL DEXAMETHASONE AND NEBULIZATION OF DEXAMETHASONE FOR REDUCING POST OPERATIVE SORE THROAT IN PATIENTS UNDERGOING GENERAL ANAESTHESIA

Dr Punitha M N1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2024年12月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
102
试验地点
1
主要终点
To assess Post Operative Sore Throat

研究概览

简要总结

As approval from Institutional Human Ethical Committee has been obtained, written and informed consent will be taken from the patients undergoing surgery. Those satisfying the inclusion and exclusion criteria are randomly allocated using a computer-generated random number table to any of the two groups.

GROUP ‘N’: Nebulization with Dexamethasone 8mg in 10ml

GROUP ‘T’: Topical Dexamethasone 8mg in 10ml

All the patients will undergo pre-anaesthetic evaluation which includes detailed history taking, physical examination and necessary investigations like complete blood count, blood urea, serum creatinine, HIV, HBsAg etc.

Tab Alprazolam 0.5mg and Cap Pantoprazole 40mg are given orally at night on the day before surgery. All the patients are kept nil per oral as per standard guidelines.

GROUP ‘N’:

Patient will be shifted to pre-operative room. Intravenous line will be secured. The patient will be nebulized with 8mg Dexamethasone [total volume 10ml- 2ml dexamethasone with 8ml normal saline] 30 minutes prior to induction. Patient will be shifted to operation theatre and standard ASA monitors will be connected. Preoperative systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, respiratory rate, oxygen saturation, electrocardiogram are recorded and appropriate intravenous fluid is started. Patient will be preoxygenated with 100% oxygen for 3minutes and pre-medications will given, induced with Propofol(2mg/kg) and Atracurium(0.5mg/kg). Patient will be intubated with appropriate sized single use disposable large volume low pressure cuffed endotracheal tube.

GROUP ‘T’

Patient will be shifted to pre-operative room. Intravenous line will be secured. Patient will be shifted to operation theatre and standard ASA monitors will be connected. Preoperative systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, respiratory rate, oxygen saturation, electrocardiogram are recorded and appropriate intravenous fluid is started. The endotracheal tube will be pre-treated by dipping in 10ml syringe (after taking out the plunger and blocking the open end) containing Dexamethasone 8mg [total volume 10ml- 2ml dexamethasone with 8ml normal saline] 10 minutes prior to intubation. Patient will be preoxygenated with 100% oxygen for 3minutes and pre-medications will be given, induced with Propofol(2mg/kg) and Atracurium(0.5mg/kg). Patient will be intubated with appropriate sized single use disposable large volume low pressure cuffed endotracheal tube.

In both the groups – Group N and Group T Cormack-Lehane grading will be noted in all patients during laryngoscopy. The cuff will be inflated with room air and cuff pressure kept around 20-25cm of water. The endotracheal tube placement will be confirmed with end-tidal carbon-dioxide concentration. Anaesthesia will be maintained on 66%:33% - N2O:O2. Cuff pressure will be monitored with cuff manometer every 15 minutes and after change in patient’s position and pressure will be kept in between 20-25cm of water. Paracetamol infusion and Ondansetron will be given intravenously for post operative pain relief and post operative nausea and vomiting. Gentle suctioning will be done and spontaneous efforts of breathing will be checked. Reversal agent-Glycopyrrolate and Neostigmine will be given when patients are able to obey verbal commands and when ventilation was considered adequate, extubation will be done.

Patients will be assessed for Sore Throat, Hoarseness of voice and Cough in 1, 6, 12, 24 hours of post-operative period.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • Patient belonging to ASA I and II 2)Mallampati Grading 1 and 2 3)Surgeries lasting for less than 2hours under General Anaesthesia.

排除标准

  • Perioperative period a) Anticipated difficult intubation b) ASA grading III and IV c) Previous Upper Airway surgeries d) Mallampati Grading 3 and 4 e) Upper Respiratory tract infection f) Chronic obstructive pulmonary disease g) Patient allergic to study medication h) Pregnant patients and Patients with history of GERD
  • Intraoperative period a) More than one laryngoscopic attempts b) Cormack-Lehane grading 3 and 4 c) Any episode of intraoperative Bronchospasm d) Any episode of intraoperative Laryngospasm e) Patient on steroid therapy.

结局指标

主要结局

To assess Post Operative Sore Throat

时间窗: The patient will be assessed for post operative sore throat in 1,6,12,24 hours after surgery

次要结局

  • To assess post operative Hoarseness of voice(To assess post operative cough)

研究者

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

Dr Punitha M N

Navodaya Medical College, Hospital And Research Centre

研究点 (1)

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