- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01672606
Effect of Rocuronium on the Acute Hypoxic Ventilatory Response in Patients With Obstructive Sleep Apnea
February 26, 2016 updated by: Malin Jonsson Fagerlund
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.
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Stockholm, Sweden, SE-17176
- Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rocuronium
Intravenous infusion of rocuronium with the goal of TOF 0.70 and >0.90
|
Partial neuromuscular blockade with rocuronium with a TOF 0.70
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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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
Outcome Measure |
Time Frame |
---|---|
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
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At baseline, with CPAP, at TOF 0.70 and at TOF >0.90. At diagnosis and after 3 month of CPAP treatment at home
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Hypoxic ventilatory response
Time Frame: At diagnosis and after 3 month of CPAP treatment at home
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At diagnosis and after 3 month of CPAP treatment at home
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Hypoxic ventilatory response during acute CPAP treatment
Time Frame: At diagnosis and after 3 month of CPAP treatment
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At diagnosis and after 3 month of CPAP treatment
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Hypercarbic ventilatory response
Time Frame: At diagnosis and after 3 month of CPAP treatment at home
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At diagnosis and after 3 month of CPAP treatment at home
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Hypercarbic ventilatory response during acute CPAP treatment
Time Frame: At diagnosis and after 3 month CPAP treatment at home
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At diagnosis and after 3 month CPAP treatment at home
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Upper airway obstruction
Time Frame: At TOF 0.70 and TOF >0.90. At diagnosis and after 3 month CPAP treatment.
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At TOF 0.70 and TOF >0.90. At diagnosis and after 3 month CPAP treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
June 1, 2012
First Submitted That Met QC Criteria
August 22, 2012
First Posted (Estimate)
August 27, 2012
Study Record Updates
Last Update Posted (Estimate)
February 29, 2016
Last Update Submitted That Met QC Criteria
February 26, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Apnea
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Signs and Symptoms, Respiratory
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Hypoxia
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Neuromuscular Agents
- Neuromuscular Nondepolarizing Agents
- Neuromuscular Blocking Agents
- Rocuronium
Other Study ID Numbers
- OSA ROC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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