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Active, Not Recruiting

NCT Number: NCT06761092

Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Anesthesiology and Intensive Therapy Udayana University

Denpasar, Bali, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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

Primary outcomes

  1. reduce post anesthesia delirium incidence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Udayana University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2025
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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