Trial Outcomes & Findings for Phamacological Reversal of Airway Instability During Sedation (NCT NCT01171118)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

2- 2 1/2 hours during study visit

Results posted on

2015-04-27

Participant Flow

Dates of recruitment August 2009 to December 2010. Subjects were recruited from advertisements.

Subjects excluded from trial before assignment to group because BMI to high, medication exclusions, lost of follow up, scheduling conflict.

Participant milestones

Participant milestones
Measure	Physostigmine vs. Placebo in Room Air vs. O2 During Sedation Each subject received the sedation protocol as described below: Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Then, subjects were randomized to the specific order of each four arms. Physostigmine (PS) vs. Placebo were randomized by DAYS. Then, on each day, subjects were randomized to receive oxygen or room air first or second. But each subject went through BOTH days and both oxygen and room air on each day. There were eight total possible sequences.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phamacological Reversal of Airway Instability During Sedation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Physostigmine/Placebo n=10 Participants Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuouslyCapsaicin : 0.075% topical cream applicationPlacebo:We 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	24.7 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 2- 2 1/2 hours during study visit

Population: This is a standard size for this type of sleep study and was performed per protocol.

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

Outcome measures

Outcome measures
Measure	Physostigmine/Oxygen n=10 Participants Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Capsaicin : 0.075% topical cream application Subjects were breathing oxygen via nasal cannula at 2 liters/minute	Placebo/Oxygen n=10 Participants Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Capsaicin : 0.075% topical cream application Subjects were breathing oxygen via nasal cannula at 2 liters/minute	Physostigmine/Room Air n=10 Participants Each subject received the sedation protocol as described below: Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Then, subjects were randomized to the specific order of each four arms. Subjects breathed room air and received placebo instead of physostigimine in this arm.	Placebo/Room Air n=10 Participants Each subject received the sedation protocol as described below: Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Then, subjects were randomized to the specific order of each four arms. Subjects breathed room air and received placebo instead of physostigimine in this arm.
AHI - Apnea Hypopnea Index	14.5 events per hour Standard Deviation 21.7	27.9 events per hour Standard Deviation 49.3	11.3 events per hour Standard Deviation 19.4	12.1 events per hour Standard Deviation 21.1

Adverse Events

Physostigmine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oxygen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Room Air

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Suzanne Karan

University of Rochester

Phone: 585-275-5161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place