Trial Outcomes & Findings for Dexmedetomidine for Postoperative Sedation in Patients Undergoing Repair of Thoracoabdominal Aortic Aneurysms (NCT NCT00409344)

Results Overview

Did not achieve this primary outcome due to no enrollment of participants. Unable to measure this outcome.

Recruitment status

TERMINATED

Study phase

PHASE4

Primary outcome timeframe

1/1/2008

Results posted on

2009-09-22

Participant Flow

Recruitment period 10/10/2006 to 1/1/2008 from a surgical intensive care unit in a tertiary hospital.

Unable to enroll participants due to hepatic impairment and many patients taking tricyclic antidepressants.

Participant milestones

Participant milestones
Measure	Saline This group will recive saline	Dexmedetomidine This group will receive dexmedetomidine
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Saline This group will recive saline	Dexmedetomidine This group will receive dexmedetomidine
Overall Study no enrollment	0	0

Baseline Characteristics

Dexmedetomidine for Postoperative Sedation in Patients Undergoing Repair of Thoracoabdominal Aortic Aneurysms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Saline This group will recive saline	Dexmedetomidine This group will receive dexmedetomidine	Total Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1/1/2008

Did not achieve this primary outcome due to no enrollment of participants. Unable to measure this outcome.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1/1/2008

The number of days each patient was in the Intensive Care Unit. Unable to measure this outcome due to no enrollment of participnats.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1/1/2008

Did not achieve this outcome due to no enrollment of participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1/1/2008

Did not achieve this outcome due to no enrollment of participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1/1/2008

Did not achieve this outcome due to no enrollment of participants, unable to measure this outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1/1/2008

Did not achieve this outcome due to no enrollment of participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1/1/2008

Did not achieve this outcome due to no enrollment of participants. Was unable to measure this outcome.

Outcome measures

Outcome data not reported

Adverse Events

Saline

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

Ulrich Schmidt, MD PhD

Massachusetts General Hospital

Phone: 617-724-6490

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place