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

Neuromuscular Blockade Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01672606
• Other study ID #: OSA ROC
• Status: Completed
• Phase: N/A
• First received: June 1, 2012
• Last updated: February 26, 2016
• Start date: May 2012
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• CPAP
• Hypoxic Ventilatory Response
• Neuromuscular Blockade
• OSA
• Rocuronium
• Sleep Apnea, Obstructive

Intervention

Drug:
• Rocuronium
Partial neuromuscular blockade with rocuronium with a TOF 0.70

Locations

Country	Name	City	State
Sweden	Department of Anesthesiology, Surgical Sciences and Intensive Care Medicine, Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Malin Jonsson Fagerlund

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Hypoxic ventilatory response		At diagnosis and after 3 month of CPAP treatment at home	Yes
Secondary	Hypoxic ventilatory response during acute CPAP treatment		At diagnosis and after 3 month of CPAP treatment	Yes
Secondary	Hypercarbic ventilatory response		At diagnosis and after 3 month of CPAP treatment at home	Yes
Secondary	Hypercarbic ventilatory response during acute CPAP treatment		At diagnosis and after 3 month CPAP treatment at home	Yes
Secondary	Upper airway obstruction		At TOF 0.70 and TOF >0.90. At diagnosis and after 3 month CPAP treatment.	Yes