Comparison of Outcomes During MRI Sedation With Midazolam-dexmedetomidine Versus Ketamine-dexmedetomidine

NCT02129426 | Terminated Results

• 1 other identifier: Ket-Dex/M-Dex MRI
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare 2 different sedation drugs (Ketamine and Midazolam) when they are used with another sedating medicine called Dexmedetomidine for MRI sedation. This study hopes to measure the impact each drug has on what happens during and after MRI sedation with Dexmedetomidine

Conditions

Sedation

Keywords

Sedation; MRI

Outcome Measures

Primary Outcomes (1)

• The Number of Participants With Hypotension and/or Bradycardia During Sedation and Recovery (Generally 2-3 Hours)

  number of participants developing hypotension and or bradycardia

  a total of 2-3 hours during sedation and recovery.

Secondary Outcomes (3)

• Percent Change in Heart Rate From Baseline

  during sedation and recovery (generally 2-3 hours)

• Percent Change in Blood Pressure From Baseline

  during sedation and recovery (generally 2-3 hours)

• The Number of Participants With Adverse Recovery-related Behaviors During Sedation Recovery

  Recovery-related behaviors will be specifically measured using the "Pediatric Anesthesia Emergence Delirium (PAED)" scale every 5 minutes from procedure completion until sedation recovery is complete (usually less than 2 hrs)

Study Arms (2)

Dexmedetomidine and Ketamine

EXPERIMENTAL

Subjects will already be getting Dexmedetomidine and Ketamine for their routine care.

Drug: Ketamine; Drug: Dexmedetomidine

Dexmedetomidine and Midazolam

ACTIVE COMPARATOR

Subjects will already be getting Dexmedetomidine and Midazolam for their routine care.

Drug: Midazolam; Drug: Dexmedetomidine

Interventions

Ketamine DRUG

Sedation medication

Dexmedetomidine and Ketamine

Midazolam DRUG

Sedation medication

Dexmedetomidine and Midazolam

Dexmedetomidine DRUG

Sedation medication

Dexmedetomidine and Ketamine; Dexmedetomidine and Midazolam

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Inpatient at Kosair Children's Hospital.
• Order placed by treating team for MRI of the brain with sedation.
• Age less than or equal to 18 years.
• Plan to sedate with dexmedetomidine, regardless of study participation.

You may not qualify if:

• Previous adverse reaction to dexmedetomidine or clonidine
• Current use of clonidine as a routine medication
• Concurrent use of a heart-rate decreasing medication (digoxin, propranolol)
• Contraindication to ketamine use
• Intracranial hypertension or traumatic brain injury
• Intraocular hypertension of eye trauma
• Pulmonary hypertension requiring medical management
• Planned additional procedure during the sedation encounter (non-brain MRI, lumbar puncture, EEG etc)

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Interventions

Ketamine; Midazolam; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: John W. Berkenbosch
• Organization: University of Louisville

john.berkenbosch@louisville.edu

502-852-3720

Study Officials

• John W. Berkenbosch, M.D.

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2014
• First Posted: May 2, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: July 14, 2021
• Results First Posted: July 7, 2021

Record last verified: 2021-07

Locations

US (1)