A Randomised prospective study to see the comparison of Intravenous versus nebulised dexmedetomidine for intubation induced sympathoadrenal stress response & post operative sore throat attenuation in patient undergoing General anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To see haemodynamic response
研究概览
简要总结
Comparison of Intravenous versus Nebulised Dexmedetomidine for Intubation Induced Sympathoadrenal Stress Response and Postoperative Sore Throat Attenuation in Patients Undergoing General Anaesthesia
Objective
Primary Objective To compare haemodynamic responses to intubation between intravenous and nebulised dexmedetomidine
Secondary Objectives To evaluate postoperative sore throat incidence To assess 24 hour analgesic requirements To monitor postoperative sedation levels using RASS To observe and compare any side effects
Study Design
Type Hospital based randomised double blind prospective study
Sample Size 100 patients divided into two groups Group D Intravenous dexmedetomidine Group N Nebulised dexmedetomidine
Study Duration Till completion of sample size after ethics approval
Inclusion Criteria
ASA physical status I and II Age between 18 and 60 years Normal airway Consent for general anaesthesia
Exclusion Criteria
ASA status III or above Difficult airway Obesity Known cardiac respiratory or neurological disease Allergy to study drugs Refusal to participate
Methodology
Patients randomly assigned to two groups Group D receives intravenous dexmedetomidine 1 microgram per kg over 10 minutes Group N receives nebulised dexmedetomidine 1 microgram per kg in normal saline Monitoring of HR BP MAP SpO2 and RASS scores pre and post intubation Assessment of postoperative sore throat and analgesic requirement up to 24 hours
Analysis
Data analyzed using SPSS software Statistical tests include t test chi square and ANOVA P value less than 0 point 05 considered significant
Ethical Approval
Study will be conducted after approval from Institutional Ethics Committee Written informed consent will be taken from all participants Study drug is FDA approved and used under supervision
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
- •ASA 1&2 Mallampati 1 and 2 Age 18-60 yrs.
排除标准
- •ASA 3 and above Mallampati 3 and 4 Allergic to drug Obese.
结局指标
主要结局
To see haemodynamic response
时间窗: To see haemodynamic response | During endotracheal intubation using iv and nebulised dexmedetomidine and compare efficacy in blunting the symapathoadrenal response
During endotracheal intubation using iv and nebulised dexmedetomidine and compare efficacy in blunting the symapathoadrenal response.
时间窗: To see haemodynamic response | During endotracheal intubation using iv and nebulised dexmedetomidine and compare efficacy in blunting the symapathoadrenal response
次要结局
- To evaluate 24 hr analgesic consumption in both groups,(To compare the postoperative sore throat)
研究者
DrVeena Patodi
JLN medical college & hospital