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

      • Stockholm, Sweden, SE-17176
        • Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital

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:
  • CPAP

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
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
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
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
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
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
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.
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.

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

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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