Desflurane or Propofol Anesthesia in Elderly Obese Patients Undergoing Total Knee Replacement

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Pedro Paulo Tanaka, Stanford University
ClinicalTrials.gov Identifier:
NCT01270620
First received: December 14, 2010
Last updated: October 1, 2015
Last verified: October 2015
Results First Received: July 18, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Obesity
Arthritis
Interventions: Drug: propofol
Drug: Desflurane

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
One hundred patients provided consented to participate in the study during June 2010 to August 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Desflurane Group

Patients will receive desflurane as general anesthetic. Desflurane is inhaled agent which will be provided continuously via ETT in concentrations varying from 4-6% according to BIS monitoring.

Desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia

Propofol Group

Patients will receive propofol as general anesthetic Propofol is an intravenous agent which will be provided continuously via IV in doses varying from 100 to 200 mcg/kg/min according to BIS monitoring.

Propofol: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia


Participant Flow:   Overall Study
    Desflurane Group     Propofol Group  
STARTED     50     50  
COMPLETED     49     47  
NOT COMPLETED     1     3  
Withdrawal by Subject                 1                 3  



  Baseline Characteristics
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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
  Description
Desflurane

Patients received propofol or desflurane as general anesthetic for total knee replacement.

Inclusion criteria: Age > 65 years old; BMI > 30 kg/m2; undergoing primary total knee replacement surgery; and ASA classification II-III

Propofol

Patients received propofol or desflurane as general anesthetic for total knee replacement.

Inclusion criteria: Age > 65 years old; BMI > 30 kg/m2; undergoing primary total knee replacement surgery; and ASA classification II-III

Total Total of all reporting groups

Baseline Measures
    Desflurane     Propofol     Total  
Number of Participants  
[units: participants]
  50     50     100  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     0     0  
>=65 years     50     50     100  
Age  
[units: years]
Mean (Standard Deviation)
  70  (4.0)     71  (5.8)     70.5  (4.6)  
Gender  
[units: participants]
     
Female     21     34     55  
Male     29     16     45  
Region of Enrollment  
[units: participants]
     
United States     50     50     100  



  Outcome Measures
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1.  Primary:   Assessment of Delirium   [ Time Frame: 48 hours ]

2.  Primary:   Recall of Digit Span   [ Time Frame: Change > 20% from baseline to 6-8 hours after surgery ]

3.  Primary:   Recall of Digit Span   [ Time Frame: Change > 20% from baseline to 48 hours after surgery ]

4.  Primary:   Digit Symbol Substitution Test   [ Time Frame: Change > 20% from baseline to 6-8 hours after surgery ]

5.  Primary:   Digit Symbol Substitution Test   [ Time Frame: Change > 20% from baseline to 48 hours after surgery ]

6.  Primary:   Trail Making Part A   [ Time Frame: Change > 20% from baseline to 6-8 hours after surgery ]

7.  Primary:   Trail Making Part A   [ Time Frame: Change > 20% from baseline to 48 hours after surgery ]

8.  Primary:   Trail Making Part B   [ Time Frame: Change > 20% from baseline to 6-8 hours after surgery ]

9.  Primary:   Trail Making Part B   [ Time Frame: Change > 20% from baseline to 48 hours after surgery ]

10.  Secondary:   - Time to Spontaneous Breathing After Desflurane/Propofol Discontinuation   [ Time Frame: first day ]

11.  Secondary:   - Time to Eye Opening After Desflurane/Propofol Discontinuation   [ Time Frame: first day ]

12.  Secondary:   - Time to Tracheal Extubation After Desflurane/Propofol Discontinuation   [ Time Frame: first day ]

13.  Secondary:   - Time to Following Command After Desflurane/Propofol Discontinuation   [ Time Frame: first day ]

14.  Secondary:   Nausea and Vomiting   [ Time Frame: 48 hours ]

15.  Secondary:   Recovery Room Time   [ Time Frame: first day ]

16.  Secondary:   B-type Natriuretic Peptide   [ Time Frame: Change from Baseline to day one ]

17.  Secondary:   N-terminal proBNP   [ Time Frame: Change from baseline to day one ]

18.  Secondary:   Troponin I   [ Time Frame: 2 days ]

19.  Secondary:   BNP   [ Time Frame: Change form baseline to post-operative day 2 ]

20.  Secondary:   ProBNP   [ Time Frame: Change from baseline to post-operative day 2 ]

21.  Secondary:   Duration of Surgery   [ Time Frame: Time from Incision to closure of surgery ]

22.  Secondary:   Duration of Anesthesia   [ Time Frame: Time from induction to extubation ]

23.  Secondary:   Amount of Intraoperative Fentanyl   [ Time Frame: From the anesthesia induction until extubation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Dr. Pedro Tanaka
Organization: Stanford University School of Medicine
phone: 6507244066
e-mail: ptanaka@stanford.edu



Responsible Party: Pedro Paulo Tanaka, Stanford University
ClinicalTrials.gov Identifier: NCT01270620     History of Changes
Other Study ID Numbers: SU-12062010-7277
IRB: 4593 ( Other Identifier: Stanford Instituinal Review Board )
SPO: 48391 ( Other Identifier: Sponsored Project Office Stanford University )
Study First Received: December 14, 2010
Results First Received: July 18, 2015
Last Updated: October 1, 2015
Health Authority: United States: Institutional Review Board