Delirium - Postoperative, Emergence Delirium
Conditions
Keywords
nebulized, dexmedetomidine, post anesthesia delirium, sevoflurane, preschool
Brief summary
Analyzing the effectiveness of nebulized dexmedetomidine 2 mcg/kg in reducing the incidence of post-anesthesia delirium in preschool children undergoing elective surgery with sevoflurane inhalation general anesthesia. Researchers will compare nebulized Dexmedetomidine to a placebo (a look-alike substance that contains no drug) to see if the drug can reduce post anesthesia delirium incidence.
Detailed description
participant will : Nebulized with the anesthetic drug dexmedetomidine at a dose of 2 mcg/kg body weight, diluted to 3 ml with 0.9% normal saline, is administered before the induction of anesthesia in the reception area. After the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the pediatric anesthesia emergence delirium score (PAED score) in the recovery room.
Interventions
DRUGNebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children
Nebulization with the anesthetic drug dexmedetomidine at a dose of 2 mcg/kg body weight, diluted to 3 ml with 0.9% normal saline, administered before the induction of anesthesia in the reception area. After the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the PAED score at 15, 30, 60, and 120 minutes post-surgery in the recovery room
PROCEDURENebulized 0.9% Normal Saline
Nebulization with normal saline 0.9% 3 ml, administered before the induction of anesthesia in the reception area. After the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the PAED score at 15, 30, 60, and 120 minutes post-surgery in the recovery room
Sponsors
Udayana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
pediatric preschool, age 2-6 years old, undergoing elective general surgery
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* Pediatric patients aged 2 to 6 years old. * Planned general anesthesia using inhalation sevoflurane with endotracheal tube techniques * Parents agree to participate in the study
Exclusion criteria
* Pediatric patients with \> ASA II. * Difficult airway management. * Emergency surgery. * Congenital abnormalities of vital organs. * Malnutrition * history or diagnosed with mental or cognitive disorders. * History of upper respiratory infection within 2 weeks before the procedure. * History of allergy to dexmedetomidine. * Surgery duration estimation exceeding 180 minutes. * Parents refuse to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reduce post anesthesia delirium incidence | 120 minutes (after extubation till discharge from recovery room) | After the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the PAED score at 15, 30, 60, and 120 minutes post-surgery in the recovery room. |
Countries
Indonesia
Outcome results
None listed