Intravenous Dexmedetomidine for Emergence Delirium in Pediatric Patient

NCT05813106 | Unknown Phase 4 DMC

• 1 other identifier: SFH-Dex Peds
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Various pharmacological interventions in peri-operative period have been used in literature to prevent ED which include use of propofol, fentanyl, ketamine, clonidine, midazolam and dexmedetomidine etc (5). Dexmedetomidine is a potent highly selective alpha-2 agonist. Its effect on the receptors in brain results in sedation resembling non-REM sleep with minimal respiratory depression (6). It has been used as continuous infusion or as fixed dose in the range between 0.15 mcg/kg to 2 mcg/kg to prevent ED in children (7, 8, 9). Higher doses result in better prevention of ED at the expense of more hemodynamic disturbances and longer PACU stay (9) while lower doses were not as effective (7). The aim of this study was to investigate the role of fixed dose of 0.2 mcg/kg dexmedetomidine in prevention of emergence delirium in pediatric patients undergoing general anesthesia.

Conditions

Emergence Delirium; Dexmeditomidine

Keywords

emergence delirium, dexmeditomidine, pediatric patients

Outcome Measures

Primary Outcomes (1)

• Emergence delirium

  Emergence delirium will be measured using PAED score

  up to 120 minutes

Secondary Outcomes (3)

• Pain score

  every 15 minutes upto discharge from PACU maximum 120 minutes

• Opioid consumption

  upto discharge from PACU maximum 120 minutes

• Side effects

  PACU stay maximum 120 minutes

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

These patients will receive 0.2 mcg/kg dexmedetomidine intravenously 30 minutes before end

Drug: Dexmedetomidine Hydrochloride

Control group

PLACEBO COMPARATOR

These patients will receive normal saline intravenously 30 minutes before end

Drug: normal saline

Interventions

Dexmedetomidine Hydrochloride DRUG

Intravenous dexmedetomidine 0.2 mcg/kg

Also known as: Precedex

Dexmedetomidine group

normal saline DRUG

normal saline

Control group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged between 2 and 12 years, scheduled to undergo general anesthesia for a surgery with an ASA score of 1 to 3 will be included in the study.

You may not qualify if:

• Parents who refused enrollment or later requested removal for the study, those who are unable to give informed consent and patients with known allergy to dexmedetomidine, psychiatric disorders or use of psychiatric medications will not be included in the study

Sponsors & Collaborators

• Security Forces Hospital: lead

Study Sites (1)

Security Forces Hospital

Riyadh, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Anwar ul Huda, FRCA

  Security Forces Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anwar ul Huda, FRCA

CONTACT

00966118024331; hudaanwar90@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 2 groups One group will receive IV dexmedetomidine Other control group receive normal saline

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: April 14, 2023
• Study Start: December 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication for 6 months
• Access Criteria: Direct communication to PI

Locations

SA (1)