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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01873612
Enrollment
11
Registered
2013-06-10
Start date
2013-05-31
Completion date
2014-09-30
Last updated
2016-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxia, Anesthetics, Conscious Sedation, Hypercapnia

Keywords

Dexmedetomidine, Propofol, Hypoxic ventilatory response, Hypercapnic ventilatory response

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.

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.

Interventions

PROCEDUREHypoxic ventilatory response

Sponsors

Karolinska University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
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

Snoring

Design outcomes

Primary

MeasureTime frameDescription
Hypoxic ventilatory responseOne day for each drug; before,during and after sedation with dexmeditomidine or propofolAcute hypoxic ventilatory response,i.e. the ventilatory response to acute hypoxia measured as change in minute ventilation over change in peripheral oxygen saturation

Secondary

MeasureTime frameDescription
hypercapnic ventilatory responseOne day for each drug; Before, during and after sedation with dexmedetomidine or propofolThe acute ventilatory response to hypercapnia, i.e. change in minute ventilation over change in end-tidal carbon dioxide

Other

MeasureTime frameDescription
upper airway obstructionOne day for each drug: Before, during and after sedation with dexmedetomidine or propofolObjective 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
Plasma concentrationOne day for each drug; At target sedationPlasma concentration of dexmedetomidine or propofol
Sedation levelOne day; During the whole experimental procedureSedation level will be measured as Richmond Agitation Sedation Scale(RASS) the observer's assessment of alertness/sedation scale (OAA/S)
Bispectral indexOne day; During the whole experimental procedureBispectral index (BIS) gives a number between 0-100

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026