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临床试验/CTRI/2025/08/092488
CTRI/2025/08/092488尚未招募4 期

Comparison of hemodynamic changes after nebulization with 4 percentage lignocaine and with 1 microgram per kg dexmedetomidine for endotracheal intubation

Government Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2025年8月19日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
104
试验地点
1
主要终点
To observe the effect of nebulization of 4%

研究概览

简要总结

My thesis investigates the comparative effects of nebulized 4 % lignocaine versus 1mcg/kg Dexmedetomidine on hemodynamic changes during endotracheal intubation using C-MAC D blade videolaryngoscopy in patients under general anaesthesia. The study aims to assess heart rate, blood pressure variations and incidence of postoperative sore throat.  A total of 104 ASA I-II adult patients scheduled for elective surgeries will be enrolled and randomly assigned to two groups receiving either lignocaine or dexmedetomidine nebulization 30 minutes before induction.  The prospective, randomized, controlled study includes standardized anaesthesia protocols and independent monitoring. Outcomes will be statistically analyzed for significance in hemodynamic stability and postoperative discomfort.  The research adheres to ethical guidelines and has institutional clearance.  This study aims to identify a safer, more effective pre-intubation nebulizing agent potentially improving patient safety and comfort during anaesthesia by mitigating pressor responses commonly triggered by laryngoscopy and intubation.

Aim

To compare the hemodynamic changes after nebulization with 4%lignocaine and 1mcg/kg Dexmedetomidine for endotracheal intubation in general anaesthesia.

Primary objective

To observe the effect of nebulization of 4%Lignocaine and nebulization of 1mcg/kg dexmedetomidine on heart rate and blood pressure after endotracheal intubation with C Mac D blade videolaryngoscopy

Secondary Objective

To observe the effect of nebulization of 4%Lignocaine and nebulization of 1mcg/kg Dexmedetomidine on postoperative sore throat after endotracheal intubation with C Mac D blade videolaryngoscopy.

Methodology

All eligible patients according to inclusion and exclusion criteria will be provided nebulization of the drug according to group allocated. The group allocation will be done using computer-generated randomization table depending on the nebulized drug used and closed sealed envelope technique will be used as blinding method.

Nebulisation will be started 30 minutes before induction of anaesthesia., nebulization of lignocaine or dexmedetomidine will be prepared and administered by an independent investigator in the preoperative area. Nebulization will be carried out with a nebulizer face mask with oxygen at 8L /min creating a fine mist till the entire volume will be dispersed, and this usually will take 15-20 minutes.  It will be stopped when there will be no further mist.

Dexmetomidine 50mcg (mixed with 0.9%normal saline to a total volume of 5ml ) nebulization to Group I (study group) and 5 ml 4%Lignocaine nebulization to Group II (control group) will be administered using a nebulizer face mask with a continuous flow of 100% oxygen at 8L/min for 15-20 minutes before induction of anaesthesia in supine position with head propped up (30-45) degree according to the group assigned.

Outcomes measured

1.The patients will be left undisturbed for a period of 10 minutes after intubation and the vital parameters like heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, pulseoximetry spo2 and EtCO2 will be recorded at baseline, after nebulization, after induction, post-intubation, 1, 5 and 10 minutes and 2 hours post surgery

  1. Postoperative will assess the patient for postoperative pain and sore throat at 2-hr post-surgery.

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

  • American Society of Anaesthesiologists (ASA) Status I and II Patients undergoing elective surgery requiring general anaesthesia with endotracheal intubation.

排除标准

  • 未提供

结局指标

主要结局

To observe the effect of nebulization of 4%

时间窗: baseline, after | nebulization, after induction, post-intubation at 1, 5 and 10 min (T1, T5 and T10) and 2 hr postsurgery

Lignocaine and nebulization of 1 mcg/kg dexmedetomidine on heart rate and blood

时间窗: baseline, after | nebulization, after induction, post-intubation at 1, 5 and 10 min (T1, T5 and T10) and 2 hr postsurgery

pressure after endotracheal intubation with

时间窗: baseline, after | nebulization, after induction, post-intubation at 1, 5 and 10 min (T1, T5 and T10) and 2 hr postsurgery

C Mac D blade videolaryngoscopy

时间窗: baseline, after | nebulization, after induction, post-intubation at 1, 5 and 10 min (T1, T5 and T10) and 2 hr postsurgery

次要结局

  • To observe the effect of nebulization of 4%(Lignocaine and nebulization of 1 mcg/kg)

研究者

发起方
Government Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

chandan nag

Government Medical College and Hospital,Chandigarh

研究点 (1)

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