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

This study is currently recruiting participants.
Verified July 2011 by Stanford University
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01270620
First received: December 14, 2010
Last updated: July 18, 2011
Last verified: July 2011
History of Changes
  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:

U.S. FDA Resources

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: December 2014
Estimated Primary Completion Date: December 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270620

Contacts
Contact: Pedro Tanaka (650) 723-6412 ptanaka@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Pedro Tanaka     650-723-6412     ptanaka@stanford.edu    
Principal Investigator: Hendrikus Lemmens            
Sub-Investigator: Barbara R. Sommer            
Study Director: Pedro Paulo Tanaka            
Sponsors and Collaborators
Stanford University
Baxter Healthcare Corporation
Investigators
Principal Investigator: Hendrikus Lemmens Stanford University
Study Director: Pedro Paulo Tanaka Stanford University
  More Information

No publications provided

Responsible Party: Hendrikus Lemmens, Stanford University School of Medicine
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: July 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
elderly obese

Additional relevant MeSH terms:
Arthritis
Obesity
Joint Diseases
Musculoskeletal Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Anesthetics
Propofol
 Desflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on June 17, 2013