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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
VA Office of Research and Development
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
200 patients were consented. One person dropped out prior to baseline testing.

Reporting Groups
Isoflurane Inhalational anesthesia with isoflurane
Propofol Total intravenous anesthesia with propofol

Participant Flow:   Overall Study
    Isoflurane   Propofol
STARTED   98   101 
COMPLETED   98   101 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Isoflurane Inhalational anesthesia with isoflurane
Propofol Total intravenous anesthesia with propofol
Total Total of all reporting groups

Baseline Measures
   Isoflurane   Propofol   Total 
Overall Participants Analyzed 
[Units: Participants]
 98   101   199 
[Units: Years]
Mean (Full Range)
 (66 to 86) 
 (65 to 91) 
 (65 to 91) 
[Units: Participants]
Female   32   39   71 
Male   66   62   128 
Region of Enrollment 
[Units: Participants]
United States   98   101   199 

  Outcome Measures

1.  Primary:   Change in Neurocognitive Performance (Z-score)   [ Time Frame: 3 months post operatively ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

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
e-mail: deborah.koltai@dm.duke.edu

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