Trial Outcomes & Findings for Cognitive Protection - Dexmedetomidine and Cognitive Reserve (NCT NCT00455143)

NCT ID: NCT00455143

Last Updated: 2019-07-17

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 27 participants
• Primary outcome timeframe: 3 months post surgery
• Results posted on: 2019-07-17

Participant Flow

Recruitment period from September 2006 to March 2008

Participant milestones

Measure	All Participants All participants enrolled in study. Information not available per arm. Study never unblinded.
Overall Study STARTED	27
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	All Participants All participants enrolled in study. Information not available per arm. Study never unblinded.
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	1
Overall Study Staff was not avail to follow patient	2
Overall Study No longer met Inclusion Criteria	1
Overall Study Surgical time, staff not available	1

Baseline Characteristics

Cognitive Protection - Dexmedetomidine and Cognitive Reserve

Baseline characteristics by cohort

Measure	All Participants n=20 Participants All participants enrolled in study. Study never unblinded. Information not available by arms.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months post surgery

Population: Main protocol became funded, study terminated, data not collected.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months post surgery

Population: This study terminated because main study became funded, data not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: prior to surgery

Population: This study terminated because main study became funded, data not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months post surgery

Population: Main protocol became funded, study terminated, data not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months post surgery

Population: Main protocol became funded, study terminated, data not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: prior to surgery

Population: Main protocol became funded, study terminated, data not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: duration of PACU stay, up to 4 days post-op

Population: Main protocol became funded, study terminated, data not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months post surgery

Population: Main protocol became funded, study terminated, data not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months post surgery

Population: Main protocol became funded, study terminated, data not collected.

Outcome measures

Outcome data not reported

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Participants n=24 participants at risk All participants enrolled in study, data missing for 3 participants. Information not available per arm. Study never unblinded.
Cardiac disorders Hypotension	4.2% 1/24
General disorders Hypoxia	4.2% 1/24
General disorders Post-operative Confusion	4.2% 1/24
Infections and infestations Cellulitis	8.3% 2/24
Blood and lymphatic system disorders Anemia	12.5% 3/24

Additional Information

Department of Anesthesiology

Icahn School of Medicine at Mount Sinai

Phone: 212-241-7473

Results disclosure agreements

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