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
  Purpose
You are invited to participate in a research study assessing your mental status in the first days after your surgery and how you will be doing in the 2 years following the surgery. The investigators hope to learn more about the incidence of postoperative confusion and a possible relation with 2 anesthesia techniques that are routinely used. The first one is an anesthesia technique that uses the inhaled anesthetic gas desflurane and the second one is an anesthesia technique that uses the anesthetic propofol administered by infusion in a vein. The investigators are also looking to see if there is a relationship between anesthesia technique and cardiovascular outcomes. You were selected as a possible participant in this study because at your age this phenomenon appears to have a greater incidence.

Condition Intervention Phase
Obesity
Arthritis
Drug: propofol
Drug: Desflurane
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Desflurane or Propofol Anesthesia in Elderly Obese Patients Undergoing Total Knee Replacement: A Pilot Assessment of Short-term and Long-term Differences in Outcome

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Assessment of Delirium [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    The primary end point was the incidence of postoperative delirium as measured by the Confusion Assessment Method (CAM).

  • Recall of Digit Span [ Time Frame: Change > 20% from baseline to 6-8 hours after surgery ] [ Designated as safety issue: No ]
    • The Digit Span subtest of the Wechsler Adult Intelligence Scale-Revised is a test that requires subjects to repeat a series of digits that have been verbally presented to them both forward and, in a later independent test, reverse order. It measures attention and working memory

  • Recall of Digit Span [ Time Frame: Change > 20% from baseline to 48 hours after surgery ] [ Designated as safety issue: No ]
    • The Digit Span subtest of the Wechsler Adult Intelligence Scale-Revised is a test that requires subjects to repeat a series of digits that have been verbally presented to them both forward and, in a later independent test, reverse order. It measures attention and working memory

  • Digit Symbol Substitution Test [ Time Frame: Change > 20% from baseline to 6-8 hours after surgery ] [ Designated as safety issue: No ]
    • The Digit Symbol Substitution Test (DSST) measures attention, working memory, sustained visual attention and psychomotor speed. Subjects are given a table that pairs digits and symbols, and asked to decipher a code using the table, completing as many as possible in 90 seconds. The DSST has been found to be more sensitive than other tests to changes in high-levels of cognition

  • Digit Symbol Substitution Test [ Time Frame: Change > 20% from baseline to 48 hours after surgery ] [ Designated as safety issue: No ]
    • The Digit Symbol Substitution Test (DSST) measures attention, working memory, sustained visual attention and psychomotor speed. Subjects are given a table that pairs digits and symbols, and asked to decipher a code using the table, completing as many as possible in 90 seconds. The DSST has been found to be more sensitive than other tests to changes in high-levels of cognition

  • Trail Making Part A [ Time Frame: Change > 20% from baseline to 6-8 hours after surgery ] [ Designated as safety issue: No ]
    • Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail A requires the subject to rapidly sequence a straightforward series. The scoring for this test is the time in seconds required for completion of the test

  • Trail Making Part A [ Time Frame: Change > 20% from baseline to 48 hours after surgery ] [ Designated as safety issue: No ]
    • Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail A requires the subject to rapidly sequence a straightforward series. The scoring for this test is the time in seconds required for completion of the test

  • Trail Making Part B [ Time Frame: Change > 20% from baseline to 6-8 hours after surgery ] [ Designated as safety issue: No ]
    • Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail B is a more difficult cognitive flexibility task requiring the subject to follow a sequential pattern while shifting cognitive sets and reflects executive functioning, although other cognitive abilities, such as psychomotor speed and visual scanning, are necessary for successful completion of the task. The scoring for this test is the time in seconds required for completion of the test

  • Trail Making Part B [ Time Frame: Change > 20% from baseline to 48 hours after surgery ] [ Designated as safety issue: No ]
    Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail B is a more difficult cognitive flexibility task requiring the subject to follow a sequential pattern while shifting cognitive sets and reflects executive functioning, although other cognitive abilities, such as psychomotor speed and visual scanning, are necessary for successful completion of the task. The scoring for this test is the time in seconds required for completion of the test


Secondary Outcome Measures:
  • - Time to Spontaneous Breathing After Desflurane/Propofol Discontinuation [ Time Frame: first day ] [ Designated as safety issue: No ]
  • - Time to Eye Opening After Desflurane/Propofol Discontinuation [ Time Frame: first day ] [ Designated as safety issue: No ]
  • - Time to Tracheal Extubation After Desflurane/Propofol Discontinuation [ Time Frame: first day ] [ Designated as safety issue: No ]
  • - Time to Following Command After Desflurane/Propofol Discontinuation [ Time Frame: first day ] [ Designated as safety issue: No ]
  • Nausea and Vomiting [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Recovery Room Time [ Time Frame: first day ] [ Designated as safety issue: No ]
  • B-type Natriuretic Peptide [ Time Frame: Change from Baseline to day one ] [ Designated as safety issue: No ]
  • N-terminal proBNP [ Time Frame: Change from baseline to day one ] [ Designated as safety issue: No ]
  • Troponin I [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Patients who had troponin level > 0.2 ng/mL

  • BNP [ Time Frame: Change form baseline to post-operative day 2 ] [ Designated as safety issue: No ]
  • ProBNP [ Time Frame: Change from baseline to post-operative day 2 ] [ Designated as safety issue: No ]
  • Duration of Surgery [ Time Frame: Time from Incision to closure of surgery ] [ Designated as safety issue: No ]
  • Duration of Anesthesia [ Time Frame: Time from induction to extubation ] [ Designated as safety issue: No ]
  • Amount of Intraoperative Fentanyl [ Time Frame: From the anesthesia induction until extubation ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: December 2010
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Propofol
Patients will receive propofol as general anesthetics.
Drug: propofol
comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
Active Comparator: Desflurane
Patients will receive desflurane as general anesthetics.
Drug: Desflurane
comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
Other Name: Suprane

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 65 years old
  • Body mass index > 30 kg/m2
  • Undergoing primary total knee arthroplasty surgery
  • American society of anesthesiology classification II-III

Exclusion Criteria:

  • Patient refusal to participate in the study
  • Patient refusal or failure of regional block
  • Patients with preexisting neuro-cognitive disorders
  • Known intolerance to any of the drugs to be used according to the study protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01270620

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Pedro Paulo Tanaka
Baxter Healthcare Corporation
Investigators
Principal Investigator: Hendrikus Lemmens Stanford University
Study Director: Pedro Paulo Tanaka Stanford University
  More Information

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

Keywords provided by Stanford University:
elderly obese

Additional relevant MeSH terms:
Anesthetics
Propofol
Desflurane
Isoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on August 25, 2016