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

NCT01270620 | Completed Phase 4 Results

• 3 other identifiers: SU-12062010-7277IRB: 4593SPO: 48391
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Arthritis

Keywords

elderly obese

Outcome Measures

Primary Outcomes (9)

• Assessment of Delirium

  The primary end point was the incidence of postoperative delirium as measured by the Confusion Assessment Method (CAM).

  48 hours

• Recall of Digit Span

  • 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

  Change > 20% from baseline to 6-8 hours after surgery

• Recall of Digit Span

  • 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

  Change > 20% from baseline to 48 hours after surgery

• Digit Symbol Substitution Test

  • 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

  Change > 20% from baseline to 6-8 hours after surgery

• Digit Symbol Substitution Test

  • 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

  Change > 20% from baseline to 48 hours after surgery

• Trail Making Part A

  • 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

  Change > 20% from baseline to 6-8 hours after surgery

• Trail Making Part A

  • 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

  Change > 20% from baseline to 48 hours after surgery

• Trail Making Part B

  • 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

  Change > 20% from baseline to 6-8 hours after surgery

• Trail Making Part B

  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

  Change > 20% from baseline to 48 hours after surgery

Secondary Outcomes (14)

• - Time to Spontaneous Breathing After Desflurane/Propofol Discontinuation

  first day

• - Time to Eye Opening After Desflurane/Propofol Discontinuation

  first day

• - Time to Tracheal Extubation After Desflurane/Propofol Discontinuation

  first day

• - Time to Following Command After Desflurane/Propofol Discontinuation

  first day

• Nausea and Vomiting

  48 hours

Study Arms (2)

Propofol

ACTIVE COMPARATOR

Patients will receive propofol as general anesthetics.

Drug: propofol

Desflurane

ACTIVE COMPARATOR

Patients will receive desflurane as general anesthetics.

Drug: Desflurane

Interventions

propofol DRUG

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

Propofol

Desflurane DRUG

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

Also known as: Suprane

Desflurane

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pedro Paulo Tanaka: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Obesity; Arthritis

Interventions

Propofol; Desflurane

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ethyl Ethers; Ethers; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Results Point of Contact

• Title: Dr. Pedro Tanaka
• Organization: Stanford University School of Medicine

ptanaka@stanford.edu

6507244066

Study Officials

• Hendrikus Lemmens

  Stanford University

  PRINCIPAL INVESTIGATOR

• Pedro Paulo Tanaka

  Stanford University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: January 5, 2011
• Study Start: December 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 22, 2015
• Results First Posted: September 16, 2015

Record last verified: 2015-10

Locations

US (1)