Sedation in Patients at Risk for Upper Airway Collapse

NCT01045122 | Completed Results DMC

• 2 other identifiers: Sleep Study CReFF award5M01RR000044
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Overview of Protocol: Between Subject - Repeated Measures design will be used to assess the airway response of two groups of subjects under two different sedated conditions. Each group will be comprised of six subjects and will be categorized according to their baseline profile for risk for SDB (\< 10 RDI or \> 25 RDI). Some subjects will have been prescribed continuous positive airway pressure (CPAP) therapy by their treating physician as a result of their overnight sleep study. CPAP treatment is effective in splinting the airway open and thus decreasing the incident of airway collapse during sleep. Thus, CPAP utilization will also be tracked as an independent and continuous variable as regular CPAP use has been found to be associated with increased resistance to UAC (upper airway collapse). The experimental conditions will evaluate upper airway patency and instability in response to two forms of intravenous sedation: propofol and dexmedetomidine. Subjects will be continuously monitored during each experimental condition for respiratory effort and flow, and for EEG, EMG, and ECG. Respiratory instability will first be assessed while subjects are under sedation without any airway provocation. The degree of respiratory instability will be quantified in terms of the following measurements: a modified Respiratory Disturbance Index (RDIsedated), respiratory arousals, and minute ventilation. The apneic periods will be classified by their mixture of central and obstructive components.All outcome measurements are assessed over the period of sedation which last for approximately one hour. Upper airway patency will be quantified in terms of the critical pharyngeal pressure (Pcrit) (the pressure beyond which complete upper airway collapse occurs, see background).

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Respiratory Disturbance Index

  respiratory events (apneas, hypopneas) per hour

  during infusion of study drugs

Study Arms (2)

Propofol

OTHER

Is an alkylphenol, is primarily indicated for use as a general anesthetic and has minimal analgesic properties.

Drug: Propofol

Dexmedetomidine

OTHER

Dexmedetomidine is an alpha-2 adrenoreceptor agonist that has sedative, hypnotic, and analgesic effects.

Drug: Dexmedetomidine

Interventions

Propofol DRUG

For propofol, the current study will employ the Marsh parameters, with an initial effect site target concentration of 1.0 mcg/ml, a level likely to produce only mild sedation. Though our patient population is expected to be predominantly obese, a previous pharmacokinetic study has validated that constant infusions utilizing the dosing scheme of mcg-1•kg-1•min will yield similar effect site concentrations.25 The effect site target will be increased in increments approximately every five minutes until the pharmacodynamic targets defined in the study are attained.

Also known as: Diprivan

Propofol

Dexmedetomidine DRUG

For dexmedetomidine, an intravenous loading dose of 0.5 mcg/kg will be infused over 10 minutes and followed by an infusion starting at 0.5 mcg/kg/hr. This infusion will be titrated up to a maximum of 1.2 mcg/kg/hr.

Also known as: Precedex

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with mild or no Sleep disorder breathing
• Patients with moderate to severe Sleep disorder breathing

You may not qualify if:

• No unstable medical conditions
• Anatomic pathology of airway
• Pregnancy or nursing
• Inability to fit an anesthesia facemask
• Excessive alcohol or drug abuse
• Bleeding abnormalities
• Claustrophobia

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Propofol; Dexmedetomidine

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Suzanne Karan
• Organization: University of Rochester Medical Center

Suzanne_Karan@urmc.rochester.edu

585-275-5161

Study Officials

• Suzanne B Karan, Medical

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Denham Ward, Medical

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 11, 2009
• First Posted: January 8, 2010
• Study Start: December 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: April 27, 2015
• Results First Posted: April 27, 2015

Record last verified: 2015-04

Locations

US (1)