Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children

NCT06761092 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: DP.04.03/D.XVII.2.2.2/76407/24
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Delirium; Delirium - Postoperative

Keywords

nebulized; dexmedetomidine; post anesthesia delirium; sevoflurane; preschool

Outcome Measures

Primary Outcomes (1)

• reduce post anesthesia delirium incidence

  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.

  120 minutes (after extubation till discharge from recovery room)

Study Arms (2)

Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children

ACTIVE COMPARATOR

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.

Drug: Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children

Nebulized Normal Saline 0.9% for Post-Anesthesia Delirium in Preschool Children

PLACEBO COMPARATOR

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.

Procedure: Nebulized 0.9% Normal Saline

Interventions

Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children DRUG

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

Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children

Nebulized 0.9% Normal Saline PROCEDURE

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

Nebulized Normal Saline 0.9% for Post-Anesthesia Delirium in Preschool Children

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Udayana University: lead

Study Sites (1)

Anesthesiology and Intensive Therapy Udayana University

Denpasar, Bali, Indonesia

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: pediatric preschool, age 2-6 years old, undergoing elective general surgery

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 7, 2025
• Study Start: December 13, 2024
• Primary Completion: February 7, 2025
• Study Completion: February 13, 2025
• Last Updated: January 22, 2025

Record last verified: 2024-12

Locations

ID (1)