Back to resultsEffect of Rocuronium on the Acute Hypoxic Ventilatory Response in Patients With Obstructive Sleep Apnea
Primary Purpose
OSA, Rocuronium, Neuromuscular Blockade
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Rocuronium
Sponsored by
About this trial
This is an interventional supportive care trial for OSA
Eligibility Criteria
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
Sites / Locations
- Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rocuronium
Arm Description
Intravenous infusion of rocuronium with the goal of TOF 0.70 and >0.90
Outcomes
Primary Outcome Measures
Hypoxic ventilatory response
Secondary Outcome Measures
Hypercarbic ventilatory response
Hypoxic ventilatory response
Hypoxic ventilatory response during acute CPAP treatment
Hypercarbic ventilatory response
Hypercarbic ventilatory response during acute CPAP treatment
Upper airway obstruction
Full Information
NCT ID
NCT01672606
First Posted
June 1, 2012
Last Updated
February 26, 2016
Sponsor
Malin Jonsson Fagerlund
1. Study Identification
Unique Protocol Identification Number
NCT01672606
Brief Title
Effect of Rocuronium on the Acute Hypoxic Ventilatory Response in Patients With Obstructive Sleep Apnea
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 Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Malin Jonsson Fagerlund
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OSA, Rocuronium, Neuromuscular Blockade, Hypoxic Ventilatory Response, CPAP
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rocuronium
Arm Type
Experimental
Arm Description
Intravenous infusion of rocuronium with the goal of TOF 0.70 and >0.90
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Other Intervention Name(s)
CPAP
Intervention Description
Partial neuromuscular blockade with rocuronium with a TOF 0.70
Primary Outcome Measure Information:
Title
Hypoxic ventilatory response
Time Frame
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 Measure Information:
Title
Hypercarbic ventilatory response
Time Frame
At baseline, with CPAP, at TOF 0.70 and at TOF >0.90. At diagnosis and after 3 month of CPAP treatment at home
Title
Hypoxic ventilatory response
Time Frame
At diagnosis and after 3 month of CPAP treatment at home
Title
Hypoxic ventilatory response during acute CPAP treatment
Time Frame
At diagnosis and after 3 month of CPAP treatment
Title
Hypercarbic ventilatory response
Time Frame
At diagnosis and after 3 month of CPAP treatment at home
Title
Hypercarbic ventilatory response during acute CPAP treatment
Time Frame
At diagnosis and after 3 month CPAP treatment at home
Title
Upper airway obstruction
Time Frame
At TOF 0.70 and TOF >0.90. At diagnosis and after 3 month CPAP treatment.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malin Jonsson Fagerlund, MD, PhD
Organizational Affiliation
Karolinska University Hospital and Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
se-17176
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Effect of Rocuronium on the Acute Hypoxic Ventilatory Response in Patients With Obstructive Sleep Apnea
We'll reach out to this number within 24 hrs