Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children

Phase 4

Active, not recruiting

• Conditions: Emergence Delirium; Delirium - Postoperative
• Interventions: Drug: Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children; Procedure: Nebulized 0.9% Normal Saline

• Registration Number: NCT06761092
• Lead Sponsor: Udayana University

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.

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-13
• Study First Submitted: 2024-12-29
• Study First Submitted QC: 2025-01-04
• Study First Posted: 2025-01-07
• Last Update Submitted: 2025-01-18
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-02-07
• Study Completion: 2025-02-13

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children	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 pediatric anesthesia emergence delirium score (PAED score) at 15, 30, 60, and 120 minutes post-surgery in the recovery room.
Nebulized Normal Saline 0.9% for Post-Anesthesia Delirium in Preschool Children	Nebulized 0.9% Normal Saline	Nebulization with normal saline 0.9% 3ml, 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) at 15, 30, 60, and 120 minutes post-surgery in the recovery room.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Anesthesiology and Intensive Therapy Udayana University; 🇮🇩 Denpasar, Bali, Indonesia