Trial Outcomes & Findings for Sedation in Patients at Risk for Upper Airway Collapse (NCT NCT01045122)

NCT ID: NCT01045122

Last Updated: 2015-04-27

Results Overview

respiratory events (apneas, hypopneas) per hour

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: during infusion of study drugs
• Results posted on: 2015-04-27

Participant Flow

Dates of recruitment April 2006 to November 2008. Subjects were recruited from advertisements, patient letters sent out through the strong sleep center.

Subjects excluded from trial before assignment to group because Prior airway surgery, unstable medical conditions.

Participant milestones

Measure	Propofol First Propofol was administered first in 5/11 subjects with a one week washout at least between the next run with dexmedetomidine	Dexmedetomidine First Dexmedetomidine was administered on the first day in 6/11 subjects with at least a one week washout between runs before the subjects underwent the experiment with propofol.
Dexmedetomidine Then Propofol STARTED	5	6
Dexmedetomidine Then Propofol COMPLETED	5	6
Dexmedetomidine Then Propofol NOT COMPLETED	0	0
Propofol Then Dexmedetomidine STARTED	5	6
Propofol Then Dexmedetomidine COMPLETED	5	6
Propofol Then Dexmedetomidine NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sedation in Patients at Risk for Upper Airway Collapse

Baseline characteristics by cohort

Measure	Propofol vs Dexmedetomidine n=11 Participants We aim to study two commonly used sedatives (propofol vs dexmedetomidine) in subjects with OSA for their propensity to produce sedation related respiratory events
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	49 years STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants
Respiratory Disturbance Index	39.99 events per hour STANDARD_DEVIATION 40.1 • n=5 Participants

PRIMARY outcome

Timeframe: during infusion of study drugs

Population: Per protocol

respiratory events (apneas, hypopneas) per hour

Outcome measures

Measure	Propofol n=11 Participants The respiratory disturbance index and airway closing pressures (Pcrit) were quantified for both arms	Dexmedetomidine n=11 Participants The respiratory disturbance index and airway closing pressures (Pcrit) were quantified for both arms
Respiratory Disturbance Index	57.52 events per hour Standard Deviation 165.6	21.32 events per hour Standard Deviation 39.2

Adverse Events

Propofol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexmedetomidine

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 Medical Center

Phone: 585-275-5161

Email: Suzanne_Karan@urmc.rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place