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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Malin Jonsson Fagerlund, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01672606
First received: June 1, 2012
Last updated: April 2, 2014
Last verified: April 2014
  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: 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 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • Hypoxic ventilatory response [ Time Frame: At diagnosis and after 3 month of CPAP treatment at home ] [ Designated as safety issue: Yes ]
  • Hypoxic ventilatory response during acute CPAP treatment [ Time Frame: At diagnosis and after 3 month of CPAP treatment ] [ Designated as safety issue: Yes ]
  • Hypercarbic ventilatory response [ Time Frame: At diagnosis and after 3 month of CPAP treatment at home ] [ Designated as safety issue: Yes ]
  • Hypercarbic ventilatory response during acute CPAP treatment [ Time Frame: At diagnosis and after 3 month CPAP treatment at home ] [ Designated as safety issue: Yes ]
  • Upper airway obstruction [ Time Frame: At TOF 0.70 and TOF >0.90. At diagnosis and after 3 month CPAP treatment. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: February 2015 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Malin Jonsson Fagerlund, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01672606     History of Changes
Other Study ID Numbers: OSA ROC
Study First Received: June 1, 2012
Last Updated: April 2, 2014
Health Authority: Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on August 21, 2014