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临床试验/CTRI/2026/02/102792
CTRI/2026/02/102792尚未招募不适用

A RANDOMIZED CLINICAL TRIAL TO COMPARE NEBULIZED ROPIVACAINE (0.75 percent) WITH NEBULIZED DEXMEDETOMIDINE ON THE HEMODYNAMIC RESPONSE TO INTUBATION IN PATIENTS UNDERGOING GENERAL ANESTHESIA

Dr Archana1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2026年2月10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
128
试验地点
1
主要终点
To compare and evaluate the effectiveness of nebulized Ropivacaine (0.75%) and nebulized Dexmedetomidine in attenuating the hemodynamic response during laryngoscopy and endotracheal intubation

研究概览

简要总结

All patients included in the study will undergo General physical examination, airway assessment and systemic examination will be done and consent will be taken one day prior to the study. Standard monitoring of hemodynamic parameters (blood pressure, pulse rate, saturation, respiration rate) are done in the preoperative room. On the day of surgery patients are divided into 2 groups with 64 patients each. GROUP D received NEBULIZED DEXMEDETOMIDINE (1mcg/kg) with normal saline 5 ml and GROUP R will receive NEBULIZED ROPIVACAINE (0.75%) 5ml.Patients will receive nebulization 15mins prior to the intubation. Patients are connected to the monitors as per as American Society of Anesthesiologist classification (ASA) guidelines and baseline parameters are monitored in the operative room. Patients are induced according to institutional policy and laryngoscopy should not exceed more than 15 seconds. 

The primary aim of the study is to compare the hemodynamic response with nebulized dexmedetomidine and nebulized ropivacaine and accordingly parameters are measured at various time points like - baseline before and after nebulization, before and after tracheal intubation, minutes after tracheal intubation, at the time of skin closure and immediately and 5 minutes after tracheal extubation.

The secondary aim of the study is to compare the hemodynamic parameters at extubation, and to compare the cough response to extubation

and the incidence rate of postoperative sore throat. Any adverse effects in the perioperative period will be managed as per the institutional policy.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • It includes patients with ASA grade 1 and 2 patients with Mallampati grade 1 and 2 elective surgeries with duration of less than 120 mins.

排除标准

  • it excludes hemodynamically unstable patients patients with history of sore throat or upper respiratory tract infection patients with allergy to local anesthetics and dexmedetomidine patients with history of cardiac, liver and renal disorders patients with difficult airway where a laryngoscopy is expected to take more than 15 seconds.

结局指标

主要结局

To compare and evaluate the effectiveness of nebulized Ropivacaine (0.75%) and nebulized Dexmedetomidine in attenuating the hemodynamic response during laryngoscopy and endotracheal intubation

时间窗: THE HEMODYNAMIC RESPONSE MEASURED | T0- baseline before nebulization | T1- immediately after nebulization | T2- before tracheal intubation | T3- immediately after tracheal intubation | T4 - 5 minutes after tracheal intubation | T5- at the closure of the skin incision | T6- immediately after tracheal extubation | T7-5 minutes after tracheal extubation

次要结局

  • TO ASSESS(1.THE HEMODYNAMIC PARAMETERS AT EXTUBATION)

研究者

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

Dr. Archana

SHRI B.M. PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER

研究点 (1)

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