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

Hypoxia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873612
• Other study ID #: PropDexHVRVolunteers
• 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

• Anesthetics
• Conscious Sedation
• Hypercapnia
• Hypoxia

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