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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01672606
First Posted: August 27, 2012
Last Update Posted: February 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Malin Jonsson Fagerlund, Karolinska University Hospital
  Purpose
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 Intervention
OSA Rocuronium Neuromuscular Blockade Hypoxic Ventilatory Response CPAP Drug: Rocuronium

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Malin Jonsson Fagerlund, Karolinska University Hospital:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]
  • Hypoxic ventilatory response [ Time Frame: At diagnosis and after 3 month of CPAP treatment at home ]
  • Hypoxic ventilatory response during acute CPAP treatment [ Time Frame: At diagnosis and after 3 month of CPAP treatment ]
  • Hypercarbic ventilatory response [ Time Frame: At diagnosis and after 3 month of CPAP treatment at home ]
  • Hypercarbic ventilatory response during acute CPAP treatment [ Time Frame: At diagnosis and after 3 month CPAP treatment at home ]
  • Upper airway obstruction [ Time Frame: At TOF 0.70 and TOF >0.90. At diagnosis and after 3 month CPAP treatment. ]

Enrollment: 11
Study Start Date: May 2012
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: CPAP

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672606


Locations
Sweden
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
  More Information

Responsible Party: Malin Jonsson Fagerlund, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01672606     History of Changes
Other Study ID Numbers: OSA ROC
First Submitted: June 1, 2012
First Posted: August 27, 2012
Last Update Posted: February 29, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Hypoxia
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs