CompletedPhase 4ACTRN12625000041459

Assessment of the Effects of Nebulised Dexmedetomidine for Premedication on Inflammatory and Oxidative Stress Response in Children Undergoing Tonsillotomy and Adenoidectomy: A Pilot Study

Assessment of the Effects of Nebulised Dexmedetomidine Premedication on Oxidative and Inflammatory Stress Response in Children Undergoing Tonsillotomy and Adenoidectomy: A Randomized Controlled Trial


Sponsor

Mother and Child Health Institute Serbia, Belgrade, Serbia - Vesna Stevanovic

Enrollment

30 participants

Start Date

Apr 23, 2023

Study Type

Interventional

Conditions

Summary

This prospective randomized clinical trial was designed to asses the effect of inhaled dexmedetomidine in premedication on oxidative and inflammatory stress in children who underwent tonsillectomy and adenoidectomy. Inclusion criteria were: children 4-13 age, ASA I-II group, scheduled for tonsillectomy and adenoidectomy under general anesthesia, We hypothesized that nebulized dexmedetomidine reduces oxidative and inflammatory stress, does not affect hemodynamics and respiratory function, induces sedation and anesthesia, and reduces the consumption of opioids and analgesics. Primary outcomes were markers of oxydative and inflammatrory stress, The secondary outcomes were to examine the difference between groups caused by inhaled dexmedetomidine in the following secondary outcome variables: degree of sedation, BIS values, hemodynamics, respiratory function, analgesic consumption, frequency of complications, delirium score, pain score.


Eligibility

Sex: Both males and femalesMin Age: 4 YearssMax Age: 13 Yearss

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Interventions

Arm 1. Interventional group received nebulized dexmedetomidine. Preparation of nebulized dexmedetomidine: Dexmedetomidine 200mcg/2ml dissolved in aqua for injections up to 8ml to final concentratio

Arm 1. Interventional group received nebulized dexmedetomidine. Preparation of nebulized dexmedetomidine: Dexmedetomidine 200mcg/2ml dissolved in aqua for injections up to 8ml to final concentration of 20mcg in 1 ml. Every patient received 2mcg/kg of dexmedetomidine dissolved with 2.5ml of normal saline in form of inhalation in duration of 15 minutes, 30 minutes before the induction of anesthesia. Nebulized dexmedetomidine was administered by anesthesiologist.


Locations(1)

Serbia and Montenegro

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