Clinical Trial: Phamacological Reversal of Airway Instability During Sedation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phamacological Reversal of Airway Instability During Sedation

Brief Summary: The investigators are attempting to demonstrate a decrease in the frequency and severity of sedation-induced respiratory arrhythmias(central and obstructive apneas) with pharmacological pre-treatment in this pilot project and then eventually to understand the mechanisms behind this decrease. The efficacy and mechanisms of these treatments, while evaluated during sleep in Obstructed Sleep Apnea (OSA) patients, have not been systematically studied during sedation in either normal subjects or OSA patients. The agent to be assessed in this study in physostigmine versus placebo.

Detailed Summary: One of the most serious side effects of drugs administered for sedation is untoward respiratory events. The relative prevalence of such events is thought to be high, occurring in up to 41% of patients in some cohorts. Many specific drugs and combinations have been recommended for moderate sedation, particularly when provided by a non-anesthesiologist. The use of an opioid and a benzodiazepine is the most frequent combination, partly because the availability of antagonists for both drugs may make a "rescue" easier. However, this combination results in frequent respiratory arrhythmias (combinations of obstructions, pauses and changes in respiratory patterns).There has not been a comprehensive study of the mechanisms underlying the disruptions of respiratory rhythm caused by agents commonly used for moderate sedation. This specific research, and the line of research it opens, has the potential to make the administration of anxiolytics and analgesics safer for patients at high risk for respiratory events.
Sponsor: University of Rochester

Current Primary Outcome: AHI - Apnea Hypopnea Index [ Time Frame: 2- 2 1/2 hours during study visit ]

This is a standard metric used to describe severity of disordered breathing during sleep.Normal healthy subjects would have an AHI value of zero during sleep. Mild disordered breathing would correspond to a value of 5 to 10 events per hours; moderate 10-25; severe would be over 25


Original Primary Outcome: EEG activity [ Time Frame: 2- 2 1/2 hours during study visit ]

These measures will be used to directly assess CNS arousability during the changes in airway pressure via power spectral analytic measure of Alpha, Beta and Gamma frequency EEG


Current Secondary Outcome:

Original Secondary Outcome: BIS monitor [ Time Frame: 2-2 1/2 hours during the study visit ]

This is a clinically useful monitor of sedation and will allow the sedation state achieved in the laboratory setting to be related to clinical sedation. It will also provide a quantitative correlation of the OAA/S and the pain VAS scores.


Information By: University of Rochester

Dates:
Date Received: July 26, 2010
Date Started: August 2009
Date Completion:
Last Updated: April 24, 2015
Last Verified: April 2015