None listed
Conditions
Brief 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.
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 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.
Sponsors
Mother and Child Health Institute Serbia, Belgrade, Serbia - Vesna Stevanovic
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
4 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
In study inclusion criteria :preschool and school children ASA classification I-II group scheduled for elective tonsilectomy and adenoidectomy.
Exclusion criteria
Exclusion criteria: cardiac, pulmonary, neurological, and renal diseases, liver damage, endocrinological diseases, allergies to drugs used in the study, obesity, long-term use of antihypertensives, corticosteroids or anti-inflammatory drugs, current or recent upper airway infection and recent vaccination.
Outcome results
None listed