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Cognitive Effects of Inhalational Versus Intravenous General Anesthesia in the Elderly

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ClinicalTrials.gov Identifier: NCT00788008
Recruitment Status : Completed
First Posted : November 10, 2008
Results First Posted : March 26, 2015
Last Update Posted : March 26, 2015
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lumbar Spondylosis
Cervical Spondylosis
Hip Osteoarthritis
Knee Osteoarthritis
Intervention Drug: inhalation anesthesia with isoflurane vs. TIVA with propofol
Enrollment 200
Recruitment Details  
Pre-assignment Details 200 patients were consented. One person dropped out prior to baseline testing.
Arm/Group Title Isoflurane Propofol
Hide Arm/Group Description Inhalational anesthesia with isoflurane Total intravenous anesthesia with propofol
Period Title: Overall Study
Started 98 101
Completed 98 101
Not Completed 0 0
Arm/Group Title Isoflurane Propofol Total
Hide Arm/Group Description Inhalational anesthesia with isoflurane Total intravenous anesthesia with propofol Total of all reporting groups
Overall Number of Baseline Participants 98 101 199
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 98 participants 101 participants 199 participants
73.38
(66 to 86)
73.13
(65 to 91)
73.25
(65 to 91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 101 participants 199 participants
Female
32
  32.7%
39
  38.6%
71
  35.7%
Male
66
  67.3%
62
  61.4%
128
  64.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 98 participants 101 participants 199 participants
98 101 199
1.Primary Outcome
Title Change in Neurocognitive Performance (Z-score)
Hide Description

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.

Time Frame 3 months post operatively
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Isoflurane Propofol
Hide Arm/Group Description:
Inhalational anesthesia with isoflurane
Total intravenous anesthesia with propofol
Overall Number of Participants Analyzed 98 101
Mean (Full Range)
Unit of Measure: z score
Memory measures
.09
(-3.3 to 3.3)
-.20
(-3.3 to 3.3)
Executive Function measures
-.42
(-8.0 to 4.4)
.01
(-8.0 to 4.4)
Time Frame [Not Specified]
Adverse Event Reporting Description Only unexpected adverse events that were related to the study were collected.
 
Arm/Group Title Isoflurane Propofol
Hide Arm/Group Description Inhalational anesthesia with isoflurane Total intravenous anesthesia with propofol
All-Cause Mortality
Isoflurane Propofol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Isoflurane Propofol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/98 (0.00%)   0/101 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Isoflurane Propofol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/98 (0.00%)   0/101 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Deborah Attix, PhD
Organization: Duke University Medical Center
Phone: 919-668-2846
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00788008     History of Changes
Other Study ID Numbers: Pro00010070
First Submitted: November 6, 2008
First Posted: November 10, 2008
Results First Submitted: December 24, 2014
Results First Posted: March 26, 2015
Last Update Posted: March 26, 2015