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临床试验/CTRI/2025/09/095450
CTRI/2025/09/095450已完成不适用

Comparison of Nebulized Dexmedetomidine, Intravenous Dexamethasone and Intra-cuff Lignocaine for Prevention of Postoperative Sore Throat: A Randomized Controlled Trial

SRM Medical College1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2025年10月7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
105
试验地点
1
主要终点
Incidence and severity of post operative sore throat

研究概览

简要总结

After obtaining institutional ethical and CTRI approval, and  obtaining patient consent, patients undergoing elective surgeries under general anaesthesia will be divided into 3 groups by computer generated random numbers and sealed envelope method. General anaesthesia is standardized, all patients will receive T Alprazolam 0.25mg as premedication on night prior to surgery. Intraoperatively all monitors will be attached, patients will be induced with Inj Fentanyl 2mcg/kg, Inj Propofol 2mg/kg, Inj Vecuronium 0.1mg/kg and intubated with appropriate size endotracheal tube. Intraoperative pain management with Inj Paracetamol 1g and additional doses of Inj Fentanyl.

Group N- Nebulized Dexmedetomidine

  • These patients will receive nebulization with dexmedetomidine 50mcg along with 1.5ml of saline 15 min before induction

  • Distilled water will be injected into the cuff of the ETT to obtain minimal occlusive volume

  • 2ml saline will be given IV 30 min after intubation

Group D- Intravenous Dexamethasone

  • These patients will receive nebulization with 2ml saline 15 min before induction

  • Distilled water will be injected into the cuff of the ETT to obtain minimal occlusive volume

-Inj Dexamethasone 8mg IV will be given 30 min after intubation

Group T- Intra-cuff Lignocaine

-These patients will receive nebulization with 2ml saline 15 min before induction

  • The cuff of the ETT will be inflated with 2 percent Lignocaine to obtain minimal occlusive volume and intra-cuff pressure will be maintained between 20-30 cm of water

-2ml saline will be given IV 30 min after intubation

A second anaesthetist will monitor the patient throughout the procedure and assess the outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • ASA PS 1 and 2 Patients undergoing elective surgeries under general anaesthesia with endotracheal intubation Duration of surgery more than one hour Normal BMI.

排除标准

  • Patients with history of respiratory diseases or Diabestes History of smoking in last one week Allergy to local anaesthetic agent Surgeries in prone position Patient refusal.

结局指标

主要结局

Incidence and severity of post operative sore throat

时间窗: Assessed at 2, 6, 12 and 24 hours in the postoperative period

次要结局

  • Incidence of postoperative nausea and vomiting(Upto 12 hours in postoperative period)
  • Intraoperative blood Pressure and Heart rate monitoring(Monitored at 15 minute intervals intraoperatively)

研究者

发起方
SRM Medical College
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Pranati Yerramilli

SRM Medical College Hospital and Research Center

研究点 (1)

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