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Does Optimized General Anesthesia Care Reduce Postoperative Delirium? (OPCare)

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ClinicalTrials.gov Identifier: NCT02604459
Recruitment Status : Recruiting
First Posted : November 13, 2015
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
Terri Monk, University of Missouri-Columbia

Brief Summary:
Postoperative delirium occurs in up to 65% of elders undergoing surgery for repair of a hip fracture and this complication is independently associated with increased morbidity, mortality, length of hospital stay, and placement in long-term care institutions. To date, the only intervention shown to be effective at minimizing postoperative delirium is a proactive geriatric consultation. This prospective randomized clinical trial will randomize 160 adults, aged 65 years or older, to either optimized general anesthesia or usual general anesthesia care for hip fracture surgery to determine if the optimized anesthesia management reduces the severity of postoperative delirium.

Condition or disease Intervention/treatment Phase
Hip Fractures Anesthesia Delirium Device: cerebral oximeter (Fore-Sight) Device: depth of anesthesia monitor (BIS) Procedure: BP management Procedure: General anesthesia Drug: propofol Drug: fentanyl Drug: sevoflurane Phase 4

Detailed Description:
Subjects will be randomized to one of two intraoperative anesthesia treatment groups: 1.) Usual care - the anesthetic management will be at the discretion of the anesthesia provider; or 1.) Optimal care - the intraoperative depth of anesthesia will be directed using a BIS monitor, blood pressure will be maintained within 20% of preoperative levels, and cerebral oxygenation will be maintained > 60% during anesthesia. Subjects will be evaluated using the Confusion Assessment Method (CAM) for the first 5 postoperative days to determine if they experience postoperative delirium.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Optimized General Anesthesia Care Reduce Postoperative Delirium In Older Patients Undergoing Hip Fracture Repair?
Study Start Date : June 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Usual general anesthesia care

Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.

General anesthesia with be maintained with propofol, fentanyl, sevoflurane

Procedure: General anesthesia
General anesthesia will be used in both groups

Drug: propofol
propofol per protocol
Other Name: diprivan

Drug: fentanyl
fentanyl per protocol
Other Name: sublimaze

Drug: sevoflurane
maintenance of anesthesia with inhaled sevoflurane
Other Name: ultane

Experimental: Optimized general anesthesia care
The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables.
Device: cerebral oximeter (Fore-Sight)
The cerebral oximeter will be monitored in the optimized care group and cerebral oxygenation will be maintained at 60% or higher.

Device: depth of anesthesia monitor (BIS)
The depth of anesthesia will be maintained between 40 and 60 in the optimized care group.

Procedure: BP management
The systolic blood pressure will be maintained within 20% of preoperative levels in the optimized care group.

Procedure: General anesthesia
General anesthesia will be used in both groups

Drug: propofol
propofol per protocol
Other Name: diprivan

Drug: fentanyl
fentanyl per protocol
Other Name: sublimaze

Drug: sevoflurane
maintenance of anesthesia with inhaled sevoflurane
Other Name: ultane




Primary Outcome Measures :
  1. Severity of postoperative delirium [ Time Frame: 5 postoperative days ]
    Delirium Rating Scale-Revised-98


Secondary Outcome Measures :
  1. Incidence of postoperative delirium [ Time Frame: 5 postoperative days ]
    Confusion Assessment Method

  2. Perioperative inflammatory response [ Time Frame: preoperative, day of surgery, and postoperative day 2 ]
    Blood will be drawn for analysis of inflammatory markers including interleukin 6 (IL6), interleukin 10 (IL10), tumor necrosis factor (TNF) alpha on the day prior to surgery, at the end of surgery and on the second postoperative day.

  3. Complication assessment [ Time Frame: 3 months and 1 year ]
    The investigators will make a telephone call to the subjects at 3 months and 1 year after surgery to determine if the subject has experienced any complications. We will ask the subjects about the occurrence of infections, strokes, cardiac problems, or respiratory problems since discharge from the hospital.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject or legal representative has voluntarily signed the informed consent approved by the Institutional Review Board,
  • Hip fracture surgery scheduled under general anesthesia
  • Subject is 65 years or older on the day of surgery

Exclusion Criteria:

  • Inability to follow directions or comprehend the English language
  • Severe uncorrected visual or auditory handicaps
  • Delirium at screening or baseline
  • Emergency surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02604459


Contacts
Contact: Terri G Monk, MD 5738822568 monkt@health.missouri.edu
Contact: Adam Zino, MPh 57388222568 zinoa@health.missouri.edu

Locations
United States, Missouri
University of Missouri Hospitals Recruiting
Columbia, Missouri, United States, 65203
Contact: Terri G Monk, MD    573-882-2568    monkt@health.missouri.edu   
Contact: Adam Zino, BS, MPH    5738843740    zinoa@health.missouri.edu   
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Terri G Monk, MD University of Missouri-Columbia

Responsible Party: Terri Monk, Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02604459     History of Changes
Other Study ID Numbers: 1212915
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hip Fractures
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Anesthetics
Propofol
Fentanyl
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Platelet Aggregation Inhibitors