Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children

Udayana University

Status and phase: Active, not recruiting; Phase 4

Conditions: Delirium - Postoperative; Emergence Delirium

Treatments: Drug: Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children; Procedure: Nebulized 0.9% Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06761092

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

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 2 to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children

Active Comparator group

Description:

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.

Treatment:

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

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

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Nebulized 0.9% Normal Saline