Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children

January 18, 2025 updated by: Jimmy Wongkar, Udayana University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Bali
      • Denpasar, Bali, Indonesia
        • Anesthesiology and Intensive Therapy Udayana University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: 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
Placebo Comparator: 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.
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
120 minutes (after extubation till discharge from recovery room)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Udayana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2024

Primary Completion (Estimated)

February 7, 2025

Study Completion (Estimated)

February 13, 2025

Study Registration Dates

First Submitted

December 29, 2024

First Submitted That Met QC Criteria

January 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 18, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DP.04.03/D.XVII.2.2.2/76407/24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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