NCT01672606

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 27, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 29, 2016

Status Verified

February 1, 2016

Enrollment Period

3.8 years

First QC Date

June 1, 2012

Last Update Submit

February 26, 2016

Conditions

OSARocuroniumNeuromuscular BlockadeHypoxic Ventilatory ResponseCPAP

Outcome Measures

Primary Outcomes (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 Outcomes (6)

  • 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

  • Hypoxic ventilatory response

    At diagnosis and after 3 month of CPAP treatment at home

  • Hypoxic ventilatory response during acute CPAP treatment

    At diagnosis and after 3 month of CPAP treatment

  • Hypercarbic ventilatory response

    At diagnosis and after 3 month of CPAP treatment at home

  • Hypercarbic ventilatory response during acute CPAP treatment

    At diagnosis and after 3 month CPAP treatment at home

  • +1 more secondary outcomes

Study Arms (1)

Rocuronium

EXPERIMENTAL

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

Drug: Rocuronium

Interventions

RocuroniumDRUG

Partial neuromuscular blockade with rocuronium with a TOF 0.70

Also known as: CPAP
Rocuronium

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital

Stockholm, se-17176, Sweden

Location

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Malin Jonsson Fagerlund, MD, PhD

    Karolinska University Hospital and Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 1, 2012

First Posted

August 27, 2012

Study Start

May 1, 2012

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 29, 2016

Record last verified: 2016-02

Locations

SE(1)