Cognitive Effects of Inhalational Versus Intravenous General Anesthesia in the Elderly

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00788008
First received: November 6, 2008
Last updated: February 7, 2014
Last verified: January 2013
  Purpose

The purpose of this research is to determine if post-operative cognition will be better if the general anesthesia for surgery is done with an inhaled (gas through a breathing tube) or intravenous (medicine injected in the IV) general anesthetic technique.


Condition Intervention
Lumbar Spondylosis
Cervical Spondylosis
Hip Osteoarthritis
Knee Osteoarthritis
Drug: inhalation anesthesia with isoflurane vs. TIVA with propofol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Inhalational Anesthesia Accelerate Postoperative Cognitive Decline?

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Neurocognitive performance at 3 months post-operatively [ Time Frame: 3 months post operatively ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: November 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Inhalational anesthesia with isoflurane
Drug: inhalation anesthesia with isoflurane vs. TIVA with propofol
variable depending upon patient
Other Name: Diprivan
Active Comparator: 2
total intravenous anesthesia with propofol
Drug: inhalation anesthesia with isoflurane vs. TIVA with propofol
variable depending upon patient
Other Name: Diprivan

Detailed Description:

A prospective randomized pre-test post-test design will be used. After obtaining informed consent, patients will be randomized to either: 1) Inhalational anesthesia with isoflurane or 2) Total intravenous anesthesia(TIVA) with propofol. Randomization will be stratified by surgical type so that this variable is equally distributed between the treatment groups. All patients will be maintained at a standard depth of anesthesia (40-60) using a Bispectral Index (BIS®) monitor. Normocarbia will be maintained in the operating room using capnography monitoring. Normothermia will be maintained throughout the procedure.

The anesthesia team providing care for these patients will be able to choose the premedication and muscle relaxant for the anesthetic technique. Patient controlled anesthesia or regional anesthetic techniques may be used for post-operative analgesia at the discretion of the anesthesia team providing care for these patients. Anesthesia will be induced with intravenous propofol and fentanyl in all patients, unless contraindicated. Patients will be mechanically ventilated with air/oxygen. Temperature will be maintained > 35º C and ventilation will be adjusted to maintain end-tidal carbon dioxide (CO2) at 35 ± 5 mmHg. Mean arterial pressure will be maintained ≥ 75% of baseline or ≥ 60 mmHg, whichever is greater, in both groups. After induction of anesthesia, the maintenance anesthesia will consist of either:

  1. Inhalational anesthesia group - isoflurane will be used for maintenance of anesthesia. Intravenous fentanyl and/or remifentanil will be used for supplementary analgesia. These agents will be administered to maintain a normal depth of anesthesia using the BIS® monitor and traditional signs of anesthetic depth.
  2. TIVA group - propofol and opioid infusions (fentanyl or remifentanil) will be used for the maintenance of anesthesia. The infusions will be adjusted to maintain a normal depth of anesthesia using the BIS® monitor along with traditional signs of anesthetic depth.

All subjects will undergo pre-operative neurocognitive testing within two weeks of their surgery, and at 3 months post-surgery. The persistence versus resolution of cognitive deficits over time will be determined with a 1 year post-surgical follow-up assessment. Pre- to post-test change scores will be compared across groups on primary and secondary outcome variables (see below) while controlling for relevant demographic variables (age, education, sex).

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients (aged 65 years or older) scheduled for elective spine or major joint replacement (total hip or total knee arthroplasty) at Duke University Medical Center or the Durham VA Medical Center

Exclusion Criteria:

  • not fluent in English and able to comprehend the English language
  • have severe visual or auditory handicaps
  • Carry a diagnosis of dementia or score < 18 on the Mini-Mental State Examination (MMSE) as calculated from the Modified Mini-Mental State (3MS) (see D4 below)
  • have allergies to eggs, propofol, isoflurane, fentanyl, remifentanil, or pregabalin
  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: NCT00788008

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
VAMC
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Terri G Monk, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00788008     History of Changes
Other Study ID Numbers: Pro00010070
Study First Received: November 6, 2008
Last Updated: February 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
spinal, joint

Additional relevant MeSH terms:
Osteoarthritis, Knee
Osteoarthritis
Osteoarthritis, Hip
Spondylosis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Spinal Diseases
Bone Diseases
Anesthetics
Isoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General

ClinicalTrials.gov processed this record on September 16, 2014