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Completed

NCT Number: NCT01873612

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

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.

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Key information

Conditions

Hypoxia Anesthetics Conscious Sedation Hypercapnia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital

Stockholm, SE-17176, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypoxic ventilatory response

Procedure

Other names: HVR

Hypercapnic ventilatory response

Procedure

Other names: HCVR

Primary outcomes

  1. Hypoxic ventilatory response

    Time frame: 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 outcomes

  1. hypercapnic ventilatory response

    Time frame: 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 outcomes

  1. upper airway obstruction

    Time frame: 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

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

    Plasma concentration of dexmedetomidine or propofol

  3. Sedation level

    Time frame: 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

    Time frame: One day; During the whole experimental procedure

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

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 10, 2013
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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