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

February 25, 2016 updated by: Malin Jonsson Fagerlund, Karolinska University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sedation with dexmedetomidine
Procedure: Hypoxic ventilatory response
Other Names:
  • HVR
Procedure: Hypercapnic ventilatory response
Other Names:
  • HCVR
EXPERIMENTAL: Sedation with propofol
Procedure: Hypoxic ventilatory response
Other Names:
  • HVR
Procedure: Hypercapnic ventilatory response
Other Names:
  • HCVR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One day for each drug; before,during and after sedation with dexmeditomidine or propofol

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One day for each drug; Before, during and after sedation with dexmedetomidine or propofol

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One day for each drug: Before, during and after sedation with dexmedetomidine or propofol
Plasma concentration
Time Frame: One day for each drug; At target sedation
Plasma concentration of dexmedetomidine or propofol
One day for each drug; At target sedation
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)
One day; During the whole experimental procedure
Bispectral index
Time Frame: One day; During the whole experimental procedure
Bispectral index (BIS) gives a number between 0-100
One day; During the whole experimental procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

June 6, 2013

First Posted (ESTIMATE)

June 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 25, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PropDexHVRVolunteers

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypoxia

Clinical Trials on Hypoxic ventilatory response

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe