NCT02652507

Brief Summary

The purpose of this research study is to examine the effects of two commonly used anesthetic drugs, dexmedetomidine and ketamine, have on the shape and muscle tone of the upper airway in children, adolescents, and young adults. The results of this study will help in making the best decisions regarding the anesthesia medications used for sedation outside of the operating room.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

1.9 years

First QC Date

January 8, 2016

Last Update Submit

July 23, 2019

Conditions

Magnetic Resonance Imaging

Keywords

SedationMRIDexmedetomidineKetamineGeneral anesthesiaMRI of BrainMRI of Brain/Spine

Outcome Measures

Primary Outcomes (2)

  • Measurement of soft palate under anesthesia

    MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan

    Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes

  • Measurement of base of tongue under anesthesia

    MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan

    Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes

Secondary Outcomes (7)

  • Anteroposterior dimension and transverse dimension of soft palate

    Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes

  • Anteroposterior dimension and transverse dimension of base of tongue

    Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes

  • Patient movement during MRI

    Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes

  • Episodes of low oxygen saturation

    Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes

  • Placement of adjunct airway

    Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes

  • +2 more secondary outcomes

Study Arms (1)

Anesthesia for MRI

OTHER

All patients will receive the same drugs. A loading dose of dexmedetomidine of 2 mcg/kg/h over ten minutes followed by a continuous infusion of 2 mcg/kg/h. Bolus dose 2 mg/kg of ketamine will be given after the initial set of research images have been taken.

Drug: DexmedetomidineDrug: Ketamine

Interventions

DexmedetomidineDRUG

2 mc/kg/h over ten minutes followed by a continuous infusion of 2 mcg/kg/h

Anesthesia for MRI
KetamineDRUG

Bolus dose 2 mg/kg after first set of research images are obtained

Anesthesia for MRI

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patient requires anesthesia for a MRI scan of the brain or MRI brain/spine
  • Patient must be 1 to 18 years of age
  • Patients legally authorized representative has given written informed consent to participate in the study

You may not qualify if:

  • Allergy to dexmedetomidine or ketamine
  • History or obstructive sleep apnea
  • The patient has a life-threatening medical condition (ASA status 4, 5, or 6)
  • The patient is not scheduled to receive anesthesia sedation for the MRI
  • Patient has a history or a family history of malignant hyperthermia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Interventions

DexmedetomidineKetamine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Mohamed Mahmoud, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2016

First Posted

January 12, 2016

Study Start

June 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

July 24, 2019

Record last verified: 2019-07

Locations

US(1)