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临床试验/CTRI/2025/08/092739
CTRI/2025/08/092739尚未招募2/3 期

EVALUATION OF TWO DIFFERENT DOSES OF NEBULISED DEXMEDETOMIDINE ON ATTENUATING HEMODYNAMIC STRESS RESPONSE TO LARYNGOSCOPY AND INTUBATION IN PATIENTS UNDERGOING SURGERY UNDER GENERAL ANAESTHESIA:A DOUBLE BLINDED RANDOMISED CONTROLLED STUDY

S Nijalingappa medical college1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年8月25日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
To estimate and compare two different doses Group-A (1mcg/kg) and Group-B (2mcg/kg) of nebulized dexmedetomidine to attenuate haemodynamic stress response to laryngoscopy and intubation at different time interval during intubation

研究概览

简要总结

The larynx is a richly innervated structure with abundant neurovascular supply. Laryngoscopy and tracheal intubation are generally associated with pressure on the larynx, which results in the activation of somatovisceral reflexes. Sympathoadrenal activation leads to the release of catecholamines, which results in a rise in hemodynamics. The duration of the intubation and the force exerted during the procedure directly affect the catecholamine response.It starts within 5–10 seconds, peaking at 1–2 minutes, and finally returning to its baseline readings in the next 5 minutes. Although this is a transient response with an average rise in systolic blood pressure (SBP) of 25–30 mmHg, and most healthy patients tolerate it without any untoward effect, it may prove to be extremely deleterious in patients with cerebrovascular or cardiovascular diseases.

It has been associated with the precipitation of cardiac ischemia, cerebral stroke ,pulmonary edema. various preemptive measures are used to attenuate this response ,mainly addressed by intravenous or local agents. Most commonly employed alfa -2 agonist agonist ,opioids, beta blockers and local anesthetics .All of them are associated with various systemic side effects such as opioids with reduced respiratory drive, sedation, and postoperative nausea and vomiting and selective alfa 2 agonists such as dexmedetomidine with hypotension and bradycardia. Most of these are used preemptively but very few are administered through the nebulisation route. Direct instillation through nebulisation is new area with lesser systemic effects, which needs to be explored.

Dexmedetomidine, an alpha 2 agonist, had been widely studied through the intravenous route where it has repeatedly proven itself to suppress the hemodynamic stress response, but systemic side effects such as hypotension and bradycardia are commonly associated, which may be troublesome. However, the recent literature has stated that the nebulization route has better bioavailability: nasal mucosa—65% and buccal mucosa—82%.

Nebulised dexmeditomidine has been reported with a very short distribution half life (6minutes) and elimination half-life(2hours) withoit being associated with systemic side effects.It has reported in literature that dexmedetomidine when administered through the nebulisation route had reduced stress response to laryngoscopy and intubation also reported that nebulised dexmeditomidine can attenuate the postoperative sore throat in patients.

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
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Adult patients of ages 20 to 60 years American Society of Anaesthesiologists grade I or II of both gender Patients undergoing elective surgery requiring GA.

排除标准

  • Patient with a history of sore throat or upper respiratory tract infection Hemodynamically unstable patients Emergency patients Patents with a history of allergy to dexmedetomidine
  • Patients with a history of cardiac, liver, or renal disorders.
  • Patient with a difficult airway where the anticipated duration of laryngoscopy exceeded 15 seconds.

结局指标

主要结局

To estimate and compare two different doses Group-A (1mcg/kg) and Group-B (2mcg/kg) of nebulized dexmedetomidine to attenuate haemodynamic stress response to laryngoscopy and intubation at different time interval during intubation

时间窗: THE PRIMARY OBJECTIVE PARAMETERS WILL BE MEASURED AT VARIOUS TIME POINT ARE | T0 baseline before the procedure of nebulization | T1 after nebulization | T2 before tracheal intubation | T3 after tracheal intubation | T4 5 minutes after tracheal intubation | T5 at the closure of skin incision | T6 immediately after tracheal extubation | T7 5 minutes after tracheal extubation

次要结局

  • 1. To estimate and compare the hemodynamic parameters in group A and group B at extubation.(2. To assess and compare the cough response at extubation and the incidence rate of postoperative sore throat between group A and group B.)

研究者

发起方
S Nijalingappa medical college
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Anilkumar Ganeshnavar

S Nijalingappa Medical College

研究点 (1)

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