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

This study is ongoing, but not recruiting participants.
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: November 20, 2014
Last verified: November 2014
  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 or desflurane
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group 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:
  • postoperative delirium and cognitive function [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

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 hoours ] [ Designated as safety issue: No ]
  • Recovery room time [ Time Frame: first day ] [ Designated as safety issue: No ]
  • B-type natriuretic peptide [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • N-terminal proBNP [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Troponin I [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Propofol or desflurane
Patients will receive propofol or desflurane as general anesthetic
Drug: propofol or 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
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

No publications provided

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
Last Updated: November 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
elderly obese

Additional relevant MeSH terms:
Anesthetics
Desflurane
Propofol
Anesthetics, General
Anesthetics, Inhalation
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014