跳至主要内容
临床试验/CTRI/2025/10/096451
CTRI/2025/10/096451尚未招募2 期

Comparison of efficacy of intranasal nebulized and intravenous routes of dexmedetomidine for blunting hemodynamic response to laryngoscopy and tracheal intubation in elective intracranial surgeries. A prospective randomized single-blind clinical study.

未提供1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2025年11月10日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
132
试验地点
1
主要终点
To compare the hemodynamic response between the intranasal, nebulized, and intravenous dexmedetomidine as premedication for blunting laryngoscopy and tracheal intubation response.

研究概览

简要总结

Laryngoscopy and tracheal intubation are common procedures that often elicit significant hemodynamic responses, including hypertension, tachycardia, arrhythmias, and an increase in intracranial pressure. This observation is supported by the finding that hemodynamic responses to tracheal intubation are associated with an increase in plasma catecholamine concentrations. Although the mechanisms underlying these responses are not completely understood, they have been attributed to a reflex sympathetic discharge caused by stimulation of the upper respiratory tract, mainly the supraglottic region, by the laryngoscope blade, along with the tracheal tube placement and cuff inflation.These effects must be reduced as much as possible, especially in high-risk patients, such as those with coronary artery disease, asthma, elevated intracranial pressure, or a cerebral aneurysm. To avoid such changes in intracranial pressure and hemodynamic parameters, various drugs are used for the attenuation of the laryngoscopic response; one such drug is Dexmedetomidine. It has also been found to be effective in attenuating the increase in ICP associated with laparoscopic surgeries. Dexmedetomidine, a highly selective alpha-2 receptor agonist, has sedative, amnestic, and analgesic-sparing effects without causing respiratory depression. It also possesses a sympatholytic effect, which can reduce the stress response to laryngoscopy and intubation. Intravenous administration is the most common and extensively studied route for Dexmedetomidine. However, intravenous administration may cause bradycardia and hypotension. Therefore, it is essential to investigate alternative routes of administration. Nebulized dexmedetomidine may be an alternative to intravenous administration because drug deposition following nebulization occurs over the nasal, buccal, as well as respiratory mucosa, resulting in better systemic absorption. Dexmedetomidine is rather rapidly and efficiently absorbed after intranasal administration; therefore, it has been used as a premedication for intravenous deep sedation in pediatric dental treatment. Intranasal administration is more convenient because it is innocuous, odorless, and requires no intravenous infusion. Furthermore, intranasal administration of a substance allows it to cross the blood-brain barrier and reach the central nervous system directly. Because of the increased vascularity of the nasal mucosa, medications can gain rapid access to the venous blood of the systemic circulation, thereby bypassing first-pass metabolism in the liver. Randomized controlled trials comparing the efficacy and side effects of all three administration routes—intranasal, nebulized, and intravenous dexmedetomidine—in attenuating the hemodynamic response to laryngoscopy and tracheal intubation specifically during elective intracranial surgeries are currently unavailable. This study was therefore designed to address this critical gap, aiming to optimize anesthetic techniques, improve perioperative outcomes, and enhance patient safety during airway manipulation in neurosurgical contexts.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator 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

  • Patients of either gender 2)Age 18 to 65 years 3)ASA class I and II 4)Patients with GCS 12 to 15.

排除标准

  • Patient refusal 2)Patients with anticipated difficult airway 3)Patients with hypertension or respiratory disorders or hepatic dysfunction or renal dysfunction 4)Patients undergoing emergency surgery 5)Pregnant patients.

结局指标

主要结局

To compare the hemodynamic response between the intranasal, nebulized, and intravenous dexmedetomidine as premedication for blunting laryngoscopy and tracheal intubation response.

时间窗: Till 15 minutes after intubation

次要结局

  • To compare the sedation score(To compare the adverse effects of dexmedetomidine administration via three routes)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Ramya L

AIIMS, RAIPUR

研究点 (1)

Loading locations...

相似试验