Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children

NCT ID: NCT06761092

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-13
• Study Completion Date: 2025-02-13

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.

Conditions

Emergence Delirium; Delirium - Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children

Intervention Type: 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 Normal Saline 0.9% for Post-Anesthesia Delirium in Preschool Children

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.

Group Type: PLACEBO_COMPARATOR

Nebulized 0.9% Normal Saline

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Udayana University

OTHER

Sponsor Role: lead

Responsible Party

Jimmy Wongkar

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Anesthesiology and Intensive Therapy Udayana University

Denpasar, Bali, Indonesia

Countries

Indonesia

Other Identifiers

DP.04.03/D.XVII.2.2.2/76407/24

Identifier Type: -

Identifier Source: org_study_id