Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children

NCT06761092 — Phase 4, Active not recruiting, 72 participants, Udayana University

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

Registry	NCT06761092
Status	Active not recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	72 (Estimated)
Sponsor	Udayana University (Other)
Conditions	Emergence Delirium, Delirium - Postoperative
Interventions	Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children, Nebulized 0.9% Normal Saline (Drug, procedure)
Dates	start 2024-12-13, primary completion 2025-02-07 (estimated), completion 2025-02-13 (estimated), first posted 2025-01-07, last updated 2025-01-22
Locations	1 site in Indonesia

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children	Active comparator	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 pediatric anesthesia emergence delirium score (PAED score) at 15, 30, 60, and 120 minutes post-surgery in the recovery room.
Nebulized Normal Saline 0.9% for Post-Anesthesia Delirium in Preschool Children	Placebo comparator	Procedure: Nebulized 0.9% Normal Saline	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.

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

+Outcome measures

Primary outcomes

reduce post anesthesia delirium incidence [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.

+Eligibility

Sex: All, ages: 2 Years to 6 Years, 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

+Locations (1)

Facility	City	Country	Status
Anesthesiology and Intensive Therapy Udayana University	Denpasar, Bali	Indonesia