Trial Outcomes & Findings for The Effects of Anesthesia on Patients Undergoing Surgery for Repair of a Thoracoabdominal Aneurysm. (NCT NCT01772537)

Results Overview

Quantitative levels of tau will be measured using ELISA assay technique in pg/ml to compare the differences between the group receiving Propofol and the groups receiving Isoflurane. .

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

From insertion of spinal drain until removal

Results posted on

2017-03-31

Participant Flow

Participant milestones

Participant milestones
Measure	Stent Graft Repair Propofol Patients have a stent graft repair receiving intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol. Propofol: Intravenous anesthetic	Stent Graft Repair Isoflurane standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane. isoflurane	Open Repair These patient will receive no intervention, just standard of care.
Overall Study STARTED	5	3	6
Overall Study COMPLETED	4	3	6
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Stent Graft Repair Propofol Patients have a stent graft repair receiving intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol. Propofol: Intravenous anesthetic	Stent Graft Repair Isoflurane standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane. isoflurane	Open Repair These patient will receive no intervention, just standard of care.
Overall Study unsuccessful lumbar drain placement	1	0	0

Baseline Characteristics

The Effects of Anesthesia on Patients Undergoing Surgery for Repair of a Thoracoabdominal Aneurysm.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stent Graft Repair Propofol n=5 Participants Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol. Propofol: Intravenous anesthetic	Stent Graft Repair Isoflurane n=3 Participants standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane. isoflurane	Open Repair n=6 Participants These patients received no intervention, just standard of care.	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Age, Continuous	67 years STANDARD_DEVIATION 13 • n=5 Participants	62 years STANDARD_DEVIATION 13 • n=7 Participants	71 years STANDARD_DEVIATION 5.3 • n=5 Participants	65.7 years STANDARD_DEVIATION 11.2 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Region of Enrollment United States	5 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants	14 participants n=4 Participants

PRIMARY outcome

Timeframe: From insertion of spinal drain until removal

Population: The data for changes in CSF levels of tau are not available. The study did not have adequate funding to appropriately measure these variables.

Quantitative levels of tau will be measured using ELISA assay technique in pg/ml to compare the differences between the group receiving Propofol and the groups receiving Isoflurane. .

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From insertion of spinal drain until removal

Population: The data for changes in CSF levels of amyloid are not available. The study did not have adequate funding to appropriately measure these variables.

Quantitative levels of amyloid will be measured using ELISA assay technique in pg/ml to compare the differences between the group receiving Propofol and the groups receiving Isoflurane.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Immediately after surgery and at 3 and 12 months post-op

Population: Of the 6 patients that received an open thoracoabdominal aneurysm repair 2 were found to have delirium. Of the 5 subjects that had stenting and received Propofol as their primary anesthetic, 0 were found to have delirium. Of the 3 stenting subjects that received Isoflurane as their primary anesthetic, 1 were found to have delirium.

Delirium was measured using the Confusion Assessment Method and the Confusion Assessment Method- Intensive Care Unit (CAM-ICU) based upon post-operative location of patient. The patients were divided into to two groups, patients that had an open thoracoabdominal aneurysm repair versus patients that had stenting of their aneurysms. Patients that had stenting of their aneurysms were also randomized to receive either Propofol or Isoflurane as for their anesthetic.

Outcome measures

Outcome measures
Measure	Propofol n=6 Participants Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol. Propofol: Intravenous anesthetic	Isoflurane n=5 Participants standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane. isoflurane	Stent Graft Aneurysm Repair Isoflurane n=3 Participants These are participants that received stenting of thoracoabdominal aneurysms instead of an open repair and received Isoflurane as their primary anesthetic.
Number of Participants With Delirium as Assessed by the Confusion Assessment Method (CAM)	2 participants	0 participants	1 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From the start of the surgery to 24 hours post-op

Population: No data is available for serum inflammatory markers. The study did not have adequate funding to appropriately measure these variables.

Serum inflammatory markers will be compared per anesthetic group, Propofol versus Isoflurane. A sample of 10 individuals from each group will have biomarkers measured

Outcome measures

Outcome data not reported

Adverse Events

Stent Graft Repair Propofol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Stent Graft Repair Isoflurane

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Open Thoracoabdominal Aneurysm Repair

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. Charles Brown

The Johns Hopkins University

Phone: 410-955-0994

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place