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Intravenous Dexmedetomidine for Emergence Delirium in Pediatric Patient

NCT05813106 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-04-14

No results posted yet for this study

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

Interventions

DRUG

Dexmedetomidine Hydrochloride

Intravenous dexmedetomidine 0.2 mcg/kg

DRUG

normal saline

normal saline

Sponsors & Collaborators

  • Security Forces Hospital

    lead OTHER

Principal Investigators

  • Anwar ul Huda, FRCA · Security Forces Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2023-04-30
Completion
2023-04-30

Countries

  • Saudi Arabia

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 NCT05813106 on ClinicalTrials.gov