NCT06761092

Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children

Nebulized Dexmedetomidine to Reduce Post-Anesthesia Delirium of Sevoflurane in Preschool Children Undergoing Elective Surgery

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Udayana University · Academic / Other
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Accepted

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.

Conditions

• Emergence Delirium
• Delirium - Postoperative

Interventions

Type	Name	Description
DRUG	Nebulized 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
PROCEDURE	Nebulized 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

Timeline

• Start date: 2024-12-13
• Primary completion: 2025-02-07
• Completion: 2025-02-13
• First posted: 2025-01-07
• Last updated: 2025-01-22

Locations

1 site across 1 country: Indonesia