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Effect of Rocuronium on the Acute Hypoxic Ventilatory Response in Patients With Obstructive Sleep Apnea

Sponsor
Malin Jonsson Fagerlund (Other)
Overall Status
Completed
CT.gov ID
NCT01672606
Collaborator
(none)
11
Enrollment
1
Location
1
Arm
45
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study describe the effect of partial neuromuscular blockade of rocuronium on the acute hypoxic ventilatory response in patients with OSA before and after 3 month of CPAP treatment.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effect of Partial Neuromuscular Blockade by Rocuronium on the Acute Hypoxic Ventilatory Response in Patients With Obstructive Sleep Apnea-before and After Three Month CPAP Treatment. A Non-randomized, Non-blinded Study.
Study Start Date :
May 1, 2012
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rocuronium

Intravenous infusion of rocuronium with the goal of TOF 0.70 and >0.90

Drug: Rocuronium
Partial neuromuscular blockade with rocuronium with a TOF 0.70
Other Names:
  • CPAP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Hypoxic ventilatory response [At baseline, with CPAP, at TOF 0.70 and at TOF >0.90. At diagnosis and after 3 month of CPAP treatment at home]

    Secondary Outcome Measures

    1. Hypercarbic ventilatory response [At baseline, with CPAP, at TOF 0.70 and at TOF >0.90. At diagnosis and after 3 month of CPAP treatment at home]

    2. Hypoxic ventilatory response [At diagnosis and after 3 month of CPAP treatment at home]

    3. Hypoxic ventilatory response during acute CPAP treatment [At diagnosis and after 3 month of CPAP treatment]

    4. Hypercarbic ventilatory response [At diagnosis and after 3 month of CPAP treatment at home]

    5. Hypercarbic ventilatory response during acute CPAP treatment [At diagnosis and after 3 month CPAP treatment at home]

    6. Upper airway obstruction [At TOF 0.70 and TOF >0.90. At diagnosis and after 3 month CPAP treatment.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Male with diagnosed moderate OSA (AHI 15-30), untreated, but planned for CPAP treatment. Healthy except for OSA and well controlled tablet treated hypertension where the treatment has not been changed during the last 3 month. None smokers. 18-70 years old. BMI <35.
    Exclusion Criteria:
    • If they don´t fit the inclusion criteria

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital Stockholm Sweden se-17176

    Sponsors and Collaborators

    • Malin Jonsson Fagerlund

    Investigators

    • Principal Investigator: Malin Jonsson Fagerlund, MD, PhD, Karolinska University Hospital and Karolinska Institutet

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Malin Jonsson Fagerlund, MD, PhD, Karolinska University Hospital
    ClinicalTrials.gov Identifier:
    NCT01672606
    Other Study ID Numbers:
    • OSA ROC
    First Posted:
    Aug 27, 2012
    Last Update Posted:
    Feb 29, 2016
    Last Verified:
    Feb 1, 2016
    Additional relevant MeSH terms:
    Sleep Apnea, Obstructive
    Hypoxia
    Rocuronium

    Study Results

    No Results Posted as of Feb 29, 2016