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

NCT ID: NCT01873612

Last Updated: 2016-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypoxia Anesthetics Conscious Sedation Hypercapnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sedation with dexmedetomidine

Sedation with dexmedetomidine

Group Type EXPERIMENTAL

Hypoxic ventilatory response

Intervention Type PROCEDURE

Hypercapnic ventilatory response

Intervention Type PROCEDURE

Sedation with propofol

Sedation with propofol

Group Type EXPERIMENTAL

Hypoxic ventilatory response

Intervention Type PROCEDURE

Hypercapnic ventilatory response

Intervention Type PROCEDURE

Interventions

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Hypoxic ventilatory response

Intervention Type PROCEDURE

Hypercapnic ventilatory response

Intervention Type PROCEDURE

Other Intervention Names

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HVR HCVR

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Malin Jonsson Fagerlund

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Malin Jonsson Fagerlund, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital and Karolinska Institutet

Locations

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

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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PropDexHVRVolunteers

Identifier Type: -

Identifier Source: org_study_id

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