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

Phase 4

Completed

• Conditions: Anesthetics; Conscious Sedation; Hypoxia; Hypercapnia
• Interventions: Procedure: Hypoxic ventilatory response; Procedure: Hypercapnic ventilatory response

• Registration Number: NCT01873612
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-10
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-25
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sedation with dexmedetomidine	Hypoxic ventilatory response	Sedation with dexmedetomidine
Sedation with dexmedetomidine	Hypercapnic ventilatory response	Sedation with dexmedetomidine
Sedation with propofol	Hypoxic ventilatory response	Sedation with propofol
Sedation with propofol	Hypercapnic ventilatory response	Sedation with propofol

Primary Outcome Measures

Name	Time	Method
Hypoxic ventilatory response	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

Name	Time	Method
hypercapnic ventilatory response	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

Trial Locations

Locations (1)

Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden