Trial Outcomes & Findings for Cognitive Effects of Inhalational Versus Intravenous General Anesthesia in the Elderly (NCT NCT00788008)
NCT ID: NCT00788008
Last Updated: 2015-03-26
Results Overview
Mean change on composite scores (z-score) for memory and executive function measures. Memory measures: Hopkins Verbal Learning Test-Revised and the Brief Visuospatial Memory Test-Revised. Executive function measures: the Trail Making Test (Army, 1944), Digit-symbol substitution and Symbol Search subtests of the Processing Speed Index of the Wechsler Adult Intelligence Scale-III (WAIS-III; Wechsler, 1997) and the Controlled Oral Word Association subtest of the Multilingual Aphasia Examination. The outcomes were constructed as summed z-score composites. They are scaled as standard deviations. Thus, a score of 0 was central on each composite, and 95% of the scores would fall within -2.0 and +2.0. While there is no minimum or maximum value is rare for any score (\<1%) to fall outside the -3.0 to +3.0 range. Higher scores (and thus positive change value) indicate an improvement of function.
COMPLETED
NA
200 participants
3 months post operatively
2015-03-26
Participant Flow
200 patients were consented. One person dropped out prior to baseline testing.
Participant milestones
| Measure |
Isoflurane
Inhalational anesthesia with isoflurane
|
Propofol
Total intravenous anesthesia with propofol
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
101
|
|
Overall Study
COMPLETED
|
98
|
101
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Effects of Inhalational Versus Intravenous General Anesthesia in the Elderly
Baseline characteristics by cohort
| Measure |
Isoflurane
n=98 Participants
Inhalational anesthesia with isoflurane
|
Propofol
n=101 Participants
Total intravenous anesthesia with propofol
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.38 years
n=39 Participants
|
73.13 years
n=41 Participants
|
73.25 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=39 Participants
|
39 Participants
n=41 Participants
|
71 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=39 Participants
|
62 Participants
n=41 Participants
|
128 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
98 participants
n=39 Participants
|
101 participants
n=41 Participants
|
199 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 3 months post operativelyMean change on composite scores (z-score) for memory and executive function measures. Memory measures: Hopkins Verbal Learning Test-Revised and the Brief Visuospatial Memory Test-Revised. Executive function measures: the Trail Making Test (Army, 1944), Digit-symbol substitution and Symbol Search subtests of the Processing Speed Index of the Wechsler Adult Intelligence Scale-III (WAIS-III; Wechsler, 1997) and the Controlled Oral Word Association subtest of the Multilingual Aphasia Examination. The outcomes were constructed as summed z-score composites. They are scaled as standard deviations. Thus, a score of 0 was central on each composite, and 95% of the scores would fall within -2.0 and +2.0. While there is no minimum or maximum value is rare for any score (\<1%) to fall outside the -3.0 to +3.0 range. Higher scores (and thus positive change value) indicate an improvement of function.
Outcome measures
| Measure |
Isoflurane
n=98 Participants
Inhalational anesthesia with isoflurane
|
Propofol
n=101 Participants
Total intravenous anesthesia with propofol
|
|---|---|---|
|
Change in Neurocognitive Performance (Z-score)
Memory measures
|
.09 z score
Interval -3.3 to 3.3
|
-.20 z score
Interval -3.3 to 3.3
|
|
Change in Neurocognitive Performance (Z-score)
Executive Function measures
|
-.42 z score
Interval -8.0 to 4.4
|
.01 z score
Interval -8.0 to 4.4
|
Adverse Events
Isoflurane
Propofol
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