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CompletedNCT01873612Updated Feb 26, 2016

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

A Phase 4 interventional study of Hypoxic ventilatory response and Hypercapnic ventilatory response in Hypoxia, Anesthetics and Conscious Sedation, sponsored by Karolinska University Hospital. Completed at 1 site in Sweden. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-26.

Sponsored by Karolinska University Hospital · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Male
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Study 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.

Read the 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.

02

Conditions studied

  • Hypoxia
  • Anesthetics
  • Conscious Sedation
  • Hypercapnia

Keywords

  • Dexmedetomidine
  • Propofol
  • Hypoxic ventilatory response
  • Hypercapnic ventilatory response
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In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.

This study's enrollment of 11 is below the median of 45 across 853 interventional studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Karolinska University Hospital is the lead sponsor of 275 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
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

Exclusion Criteria:

Snoring

05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Sedation with dexmedetomidine

    Sedation with dexmedetomidine

    Procedure: Hypoxic ventilatory response · Procedure: Hypercapnic ventilatory response

  • Experimental
    Sedation with propofol

    Sedation with propofol

    Procedure: Hypoxic ventilatory response · Procedure: Hypercapnic ventilatory response

Interventions

  • ProcedureHypoxic ventilatory response

    Also known as: HVR

  • ProcedureHypercapnic ventilatory response

    Also known as: HCVR

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: One day for each drug; before,during and after sedation with dexmeditomidine or propofol

Secondary outcomes

  1. hypercapnic ventilatory response

    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 outcomes

  1. 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

    Time frame: One day for each drug: Before, during and after sedation with dexmedetomidine or propofol

  2. Plasma concentration

    Plasma concentration of dexmedetomidine or propofol

    Time frame: One day for each drug; At target sedation

  3. Sedation level

    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

  4. Bispectral index

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

    Time frame: One day; During the whole experimental procedure

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Study locations

1 site
  • Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital
    Stockholm, SE-17176, Sweden
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01873612
Lead sponsor
Karolinska University Hospital
Responsible party
Malin Jonsson Fagerlund (MD, PhD, Karolinska University Hospital) — Principal investigator
First posted
Jun 10, 2013
Start date
May 2013
Primary completion
Sep 2014
Completion
Sep 2014
Last update
Feb 26, 2016

Study contacts

Malin Jonsson Fagerlund, MD, PhD
principal investigator · Karolinska University Hospital and Karolinska Institutet

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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