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Dexmedetomidine Cycling and Sleep in the Pediatric ICU

NCT05003102 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2022-05-10

No results posted yet for this study

Summary

This is a study of mechanically ventilated pediatric intensive care unit (ICU) teenage patients and the effects of the medication dexmedetomidine on sleep, delirium, and sedation level. The Investigators will assess sleep with an 8 lead polysomnogram study and increase the medication at night for one night to see if the sleep architecture changes. The Investigators will assess their sleep with our unit's sedation protocol for an additional night.

Conditions

  • Critical Illness
  • Sedation Complication
  • Delirium

Interventions

DRUG

Dexmedetomidine Hydrochloride - Cycling

Dexmedetomidine Hydrochloride infusion at 0.5 mcg/kg titrated to 0.3 mcg/kg/hr up to a max drip rate of 2 mcg/kg/hr.

DRUG

Fentanyl - PICU Standard

fentanyl infusion at 1 mcg/kg/hr up to a max drip rate of 5 mcg/kg/hr

DRUG

Dexmedetomidine Hydrochloride - PICU Standard

Dexmedetomidine Hydrochloride infusion at 0.3 mcg/kg titrated to 0.5 mcg/kg/hr up to a max drip rate of 2 mcg/kg/hr

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Chiara N Foster, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-02-20
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States

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 NCT05003102 on ClinicalTrials.gov