NCT01873612

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

1.3 years

First QC Date

May 29, 2013

Last Update Submit

February 25, 2016

Conditions

HypoxiaAnestheticsConscious SedationHypercapnia

Keywords

DexmedetomidinePropofolHypoxic ventilatory responseHypercapnic ventilatory response

Outcome Measures

Primary Outcomes (1)

  • Hypoxic ventilatory response

    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 Outcomes (1)

  • hypercapnic ventilatory response

    One day for each drug; Before, during and after sedation with dexmedetomidine or propofol

Other Outcomes (4)

  • upper airway obstruction

    One day for each drug: Before, during and after sedation with dexmedetomidine or propofol

  • Plasma concentration

    One day for each drug; At target sedation

  • Sedation level

    One day; During the whole experimental procedure

  • +1 more other outcomes

Study Arms (2)

Sedation with dexmedetomidine

EXPERIMENTAL

Sedation with dexmedetomidine

Procedure: Hypoxic ventilatory responseProcedure: Hypercapnic ventilatory response

Sedation with propofol

EXPERIMENTAL

Sedation with propofol

Procedure: Hypoxic ventilatory responseProcedure: Hypercapnic ventilatory response

Interventions

Hypoxic ventilatory responsePROCEDURE
Also known as: HVR
Sedation with dexmedetomidineSedation with propofol
Hypercapnic ventilatory responsePROCEDURE
Also known as: HCVR
Sedation with dexmedetomidineSedation with propofol

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Snoring

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Stockholm, SE-17176, Sweden

Location

MeSH Terms

Conditions

HypoxiaHypercapnia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Malin Jonsson Fagerlund, MD, PhD

    Karolinska University Hospital and Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 10, 2013

Study Start

May 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 26, 2016

Record last verified: 2016-02

Locations

SE(1)