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Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children

NCT06761092 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-01-22

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Udayana University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-13
Primary Completion
2025-02-07
Completion
2025-02-13

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06761092 on ClinicalTrials.gov