Trial Outcomes & Findings for Intravenous Versus Inhalational Anesthesia in Parkinson's Disease (NCT NCT00615472)
NCT ID: NCT00615472
Last Updated: 2015-07-13
Results Overview
A battery/Questionnaire of neuropsych examinations is given to the subjects to measure improvement based on change of scores and standard deviation. The battery consists of questions regarding delirium, cognitive and motor changes and yields a combination assessment of all 3 elements.
TERMINATED
NA
58 participants
Four months
2015-07-13
Participant Flow
We enrolled only a few patients. Our neurocognitive battery was too hard for patients to get through. Therefore, the study was stopped.
Participant milestones
| Measure |
Inhaled Anesthesia
Inhaled Anesthesia - isoflurane
|
Intravenous Anesthesia
Intravenous Anesthesia - propofol, remifentanil
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
28
|
|
Overall Study
COMPLETED
|
30
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intravenous Versus Inhalational Anesthesia in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Inhaled Anesthesia
n=30 Participants
Inhaled Anesthesia - isoflurane
Isoflurane: Group 1 Inhaled anesthesia Patients will be maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min).
|
Intravenous Anesthesia
n=28 Participants
Intravenous Anesthesia - propofol, remifentanil
Remifentanil: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min.
Propofol: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Age, Continuous
|
67 years
n=99 Participants
|
69 years
n=107 Participants
|
68 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
28 participants
n=107 Participants
|
58 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Four monthsA battery/Questionnaire of neuropsych examinations is given to the subjects to measure improvement based on change of scores and standard deviation. The battery consists of questions regarding delirium, cognitive and motor changes and yields a combination assessment of all 3 elements.
Outcome measures
| Measure |
Group 1
n=30 Participants
Inhaled Anesthesia - isoflurane
Isoflurane: Group 1 Inhaled anesthesia Patients will be maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min).
|
Group 2
n=28 Participants
Intravenous Anesthesia - propofol, remifentanil
Remifentanil: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min.
Propofol: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min.
|
|---|---|---|
|
Number of Participants With Improved Postoperative Delirium and Cognitive and Motor Changes
|
6 participants
|
5 participants
|
Adverse Events
Group 1
Group 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place