Back to resultsAcute Ventilatory Response to Hypoxia During Sedation With Dexmedetomidine Compared to Propofol in Healthy Male Volunteers
Primary Purpose
Hypoxia, Anesthetics, Conscious Sedation
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Hypoxic ventilatory response
Hypercapnic ventilatory response
Sponsored by
About this trial
This is an interventional basic science trial for Hypoxia focused on measuring Dexmedetomidine, Propofol, Hypoxic ventilatory response, Hypercapnic ventilatory response
Eligibility Criteria
Inclusion Criteria:
- Male
- Age 18-40
- American Society of Anesthesiologist´s classification (ASA) 1, i.e. healthy
- No medication
- No allergies
- Non-smoker/no snuff, i.e. no nicotine intake
- Normal weight, BMI <26
Exclusion Criteria:
Snoring
Sites / Locations
- Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sedation with dexmedetomidine
Sedation with propofol
Arm Description
Sedation with dexmedetomidine
Sedation with propofol
Outcomes
Primary Outcome Measures
Hypoxic ventilatory response
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
hypercapnic ventilatory response
The acute ventilatory response to hypercapnia, i.e. change in minute ventilation over change in end-tidal carbon dioxide
Full Information
NCT ID
NCT01873612
First Posted
May 29, 2013
Last Updated
February 25, 2016
Sponsor
Karolinska University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01873612
Brief Title
Acute Ventilatory Response to Hypoxia During Sedation With Dexmedetomidine Compared to Propofol in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Anesthetics, Conscious Sedation, Hypercapnia
Keywords
Dexmedetomidine, Propofol, Hypoxic ventilatory response, Hypercapnic ventilatory response
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sedation with dexmedetomidine
Arm Type
Experimental
Arm Description
Sedation with dexmedetomidine
Arm Title
Sedation with propofol
Arm Type
Experimental
Arm Description
Sedation with propofol
Intervention Type
Procedure
Intervention Name(s)
Hypoxic ventilatory response
Other Intervention Name(s)
HVR
Intervention Type
Procedure
Intervention Name(s)
Hypercapnic ventilatory response
Other Intervention Name(s)
HCVR
Primary Outcome Measure Information:
Title
Hypoxic ventilatory response
Description
Acute hypoxic ventilatory response,i.e. the ventilatory response to acute hypoxia measured as change in minute ventilation over change in peripheral oxygen saturation
Time Frame
One day for each drug; before,during and after sedation with dexmeditomidine or propofol
Secondary Outcome Measure Information:
Title
hypercapnic ventilatory response
Description
The acute ventilatory response to hypercapnia, i.e. change in minute ventilation over change in end-tidal carbon dioxide
Time Frame
One day for each drug; Before, during and after sedation with dexmedetomidine or propofol
Other Pre-specified Outcome Measures:
Title
upper airway obstruction
Description
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
Time Frame
One day for each drug: Before, during and after sedation with dexmedetomidine or propofol
Title
Plasma concentration
Description
Plasma concentration of dexmedetomidine or propofol
Time Frame
One day for each drug; At target sedation
Title
Sedation level
Description
Sedation level will be measured as Richmond Agitation Sedation Scale(RASS) the observer's assessment of alertness/sedation scale (OAA/S)
Time Frame
One day; During the whole experimental procedure
Title
Bispectral index
Description
Bispectral index (BIS) gives a number between 0-100
Time Frame
One day; During the whole experimental procedure
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male
Age 18-40
American Society of Anesthesiologist´s classification (ASA) 1, i.e. healthy
No medication
No allergies
Non-smoker/no snuff, i.e. no nicotine intake
Normal weight, BMI <26
Exclusion Criteria:
Snoring
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malin Jonsson Fagerlund, MD, PhD
Organizational Affiliation
Karolinska University Hospital and Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
SE-17176
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Acute Ventilatory Response to Hypoxia During Sedation With Dexmedetomidine Compared to Propofol in Healthy Male Volunteers
We'll reach out to this number within 24 hrs