To Evaluate Effect of Nebulized Dexmedetomedine Upon Blunting Autonomic Response of Laeyngoscopy and Intubation in Patients Undergoing Elective Intubation

Официальное название

To Evaluate Effect of Nebulized Dexmedetomedine Upon Blunting Autonomic Response of Laryngoscopy and Intubation in Patients Undergoung Elective Intubation

Обзор

Laryngoscopy and intubation are painful stimuli ,that results in adverse physiological outcomes,like tachycrdia ,hypertension,arrythmiaa,pulmonary edema. The main objective of study is to blunt the autonomic response of laryngoscopy and intubation. Title of the study :To evaluate the effect of dexmedetimedine nebulization upon blunting autonomic response of laryngoscopy and intubation in patients undergoing elective intubation. It is randomized control trial,sample size was calculated by using openEpi sample size calculator By using SBPafter 1 min of laeyngoscopy in decmedetomedine versus group were 113.2+\_14.503and 125.92+\_15.263 respectively,power 95 percent and confidence 95 percent ,The required sample size for the study is 72( 36 ) in each group. After taking informed consent patients are randomly divided into two groups via opaque sealed envelop technique.Half of envelops will be labelled as letter D ,and half will be labelled as letter C .Patients in group D will be nebulized with dexmedetomedine with dose of 1ug/kg made total volume of 5 ml with normal saline.While group C will be nebulized with 5 ml of 0.9 percent normal saline 30 min prior to elective intubation.Hemodynamic parmmeters heart rate ,systolic bp,diastolic bp,MAP will be noted at baseline and 0,1,5,10 min after inrubation

Вмешательства

• Препарат Nebulization of dexmedetomedine in group D
  After taking informed consent ,patients are divided into 2 groups by using opaque sealed envelop technique ,half envelope were labelled with letter D ,half were labelled with letter patients in group D will be nebulized wirh dexmedetimedine wuth dose of 1ug/kgwith made total volune of 5ml by mixing with norml saline 30 min prior to intubation
• Препарат Nebulizition with normal saline in group C,after taking informed consent patients in group cwill be nebulized with 5 ml of normal saline 30 min prior to elective intubation ,HR,SBP,DBP,MAP monitored.
  Groyp c will be nebulized with normal saline 30 min prior to intubation,hemodynamic parameters heart rate,systolic bp ,diastolic bp,MAP, will be monitored at baseline,0,1,5,10 min after intubation.

Первичные конечные точки

• heart rate will be recorded at 0,1,5,10 min after laryngoscopy and intubation [Срок оценки: Heart rate will be monitired at base line,0min,1min,5min,10min after intervention]
• SBP,DBP,MAP. measurement will be required at o ,1,5,10 min after laryngoscopy and intubation. [Срок оценки: SBP,DBP,MAP, will be recorded at 0,1,5,10 min after laryngoscopy and intubation]

Критерии участия

Критерии включения

Age 18-65 years ASAI-III Both genders Patients undergoing elective intubation

Критерии исключения

Patients with renal hepatic or neurological disease Bleeding diathesis Mallampatti III-IV Previous histoey of difficult intubation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Пакистан · 1 центр

• Hafiza Javeria Jawed — Karachi

Идентификаторы

NCT: NCT07480304 · IRB4343/DUHS/Approval/2025/479

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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