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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01873612
Other study ID # PropDexHVRVolunteers
Secondary ID
Status Completed
Phase Phase 4
First received May 29, 2013
Last updated February 25, 2016
Start date May 2013
Est. completion date September 2014

Study information

Verified date February 2016
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Procedure:
Hypoxic ventilatory response

Hypercapnic ventilatory response


Locations

Country Name City State
Sweden Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other upper airway obstruction 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 One day for each drug: Before, during and after sedation with dexmedetomidine or propofol Yes
Other Plasma concentration Plasma concentration of dexmedetomidine or propofol One day for each drug; At target sedation No
Other Sedation level Sedation level will be measured as Richmond Agitation Sedation Scale(RASS) the observer's assessment of alertness/sedation scale (OAA/S) One day; During the whole experimental procedure Yes
Other Bispectral index Bispectral index (BIS) gives a number between 0-100 One day; During the whole experimental procedure Yes
Primary 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 One day for each drug; before,during and after sedation with dexmeditomidine or propofol Yes
Secondary hypercapnic ventilatory response The acute ventilatory response to hypercapnia, i.e. change in minute ventilation over change in end-tidal carbon dioxide One day for each drug; Before, during and after sedation with dexmedetomidine or propofol Yes
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