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

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ClinicalTrials.gov Identifier: NCT01873612
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
Malin Jonsson Fagerlund, Karolinska University Hospital

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.

Condition or disease Intervention/treatment Phase
Hypoxia Anesthetics Conscious Sedation Hypercapnia Procedure: Hypoxic ventilatory response Procedure: Hypercapnic ventilatory response Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : May 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sedation with dexmedetomidine
Sedation with dexmedetomidine
Procedure: Hypoxic ventilatory response
Other Name: HVR

Procedure: Hypercapnic ventilatory response
Other Name: HCVR

Experimental: Sedation with propofol
Sedation with propofol
Procedure: Hypoxic ventilatory response
Other Name: HVR

Procedure: Hypercapnic ventilatory response
Other Name: HCVR




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873612


Locations
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Sweden
Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital
Stockholm, Sweden, SE-17176
Sponsors and Collaborators
Karolinska University Hospital
Investigators
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Principal Investigator: Malin Jonsson Fagerlund, MD, PhD Karolinska University Hospital and Karolinska Institutet

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Responsible Party: Malin Jonsson Fagerlund, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01873612     History of Changes
Other Study ID Numbers: PropDexHVRVolunteers
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: February 2016

Keywords provided by Malin Jonsson Fagerlund, Karolinska University Hospital:
Dexmedetomidine
Propofol
Hypoxic ventilatory response
Hypercapnic ventilatory response

Additional relevant MeSH terms:
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Hypoxia
Hypercapnia
Signs and Symptoms, Respiratory
Signs and Symptoms
Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action