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Acute Ventilatory Response to Hypoxia During Sedation With Dexmedetomidine Compared to Propofol in Healthy Male Volunteers

Sponsor
Karolinska University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01873612
Collaborator
(none)
11
Enrollment
1
Location
2
Arms
16
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overall aim with this project is to investigate the effect of dexmedetomidine on control of breathing in healthy volunteers and to compare it with propofol at the same degree of sedation.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Hypoxic ventilatory response
  • Procedure: Hypercapnic ventilatory response
 Phase 4

Detailed Description

15 volunteers will be investigated for their hypoxic and hypercapnic ventilatory response during sedation with dexmedetomidine and propofol in a randomized cross-over study.

6 volunteers will be investigated for their repeated response to hypoxia and hypercapnia in order to validate the method.

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Sep 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sedation with dexmedetomidine

Sedation with dexmedetomidine

Procedure: Hypoxic ventilatory response
Other Names:
  • HVR

    • Procedure: Hypercapnic ventilatory response
    Other Names:
  • HCVR

    		•
    Experimental: Sedation with propofol

    Sedation with propofol

    Procedure: Hypoxic ventilatory response
    Other Names:
  • HVR

    • Procedure: Hypercapnic ventilatory response
    Other Names:
  • HCVR

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Hypoxic ventilatory response [One day for each drug; before,during and after sedation with dexmeditomidine or propofol]

      Acute hypoxic ventilatory response,i.e. the ventilatory response to acute hypoxia measured as change in minute ventilation over change in peripheral oxygen saturation

    Secondary Outcome Measures

    1. hypercapnic ventilatory response [One day for each drug; Before, during and after sedation with dexmedetomidine or propofol]

      The acute ventilatory response to hypercapnia, i.e. change in minute ventilation over change in end-tidal carbon dioxide

    Other Outcome Measures

    1. upper airway obstruction [One day for each drug: Before, during and after sedation with dexmedetomidine or propofol]

      Objective signs of upper airway obstruction, e.g. Interruption of airflow at the same time as breathing movements of the thoracic wall, paradoxal breathing, increased airway resistance

    2. Plasma concentration [One day for each drug; At target sedation]

      Plasma concentration of dexmedetomidine or propofol

    3. Sedation level [One day; During the whole experimental procedure]

      Sedation level will be measured as Richmond Agitation Sedation Scale(RASS) the observer's assessment of alertness/sedation scale (OAA/S)

    4. Bispectral index [One day; During the whole experimental procedure]

      Bispectral index (BIS) gives a number between 0-100

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Male

    2. Age 18-40

    3. American Society of Anesthesiologist´s classification (ASA) 1, i.e. healthy

    4. No medication

    5. No allergies

    6. Non-smoker/no snuff, i.e. no nicotine intake

    7. Normal weight, BMI <26

    Exclusion Criteria:

    Snoring

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital Stockholm Sweden SE-17176

    Sponsors and Collaborators

    • Karolinska University Hospital

    Investigators

    • Principal Investigator: Malin Jonsson Fagerlund, MD, PhD, Karolinska University Hospital and Karolinska Institutet

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Malin Jonsson Fagerlund, MD, PhD, Karolinska University Hospital
    ClinicalTrials.gov Identifier:
    NCT01873612
    Other Study ID Numbers:
    • PropDexHVRVolunteers
    First Posted:
    Jun 10, 2013
    Last Update Posted:
    Feb 26, 2016
    Last Verified:
    Feb 1, 2016
    Keywords provided by Malin Jonsson Fagerlund, MD, PhD, Karolinska University Hospital
    Dexmedetomidine
    Propofol
    Hypoxic ventilatory response
    Hypercapnic ventilatory response
    Additional relevant MeSH terms:
    Hypoxia
    Hypercapnia

    Study Results

    No Results Posted as of Feb 26, 2016