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ACTIVE NOT RECRUITING
NCT06761092
PHASE4

Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children

Sponsor: Udayana University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Years - 6 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2024-12-13

Completion Date

2025-02-13

Last Updated

2025-01-22

Healthy Volunteers

Yes

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

Locations (1)

Anesthesiology and Intensive Therapy Udayana University

Denpasar, Bali, Indonesia