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

Primary Purpose

Hip Fractures, Anesthesia, Delirium

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cerebral oximeter (Fore-Sight)
depth of anesthesia monitor (BIS)
BP management
General anesthesia
propofol
fentanyl
sevoflurane
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Missouri Hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Other

Arm Label

Usual general anesthesia care

Optimized general anesthesia care

Mini Mental State Exam

Tested and Excluded

Arm Description

Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane

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.

Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane

Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane

Outcomes

Primary Outcome Measures

Severity of Postoperative Delirium
Delirium Rating Scale-Revised-98 (DRS-R-98) is a 16-item clinician-rated scale with 13 severity items and 3 diagnostic items (maximum severity score of 39 points). Higher scores indicate more severe delirium; score of 0 indicates no delirium. Only the number of patients who had high scores on the DRS-R-98 are reported.

Secondary Outcome Measures

Number of Patients Who Presented With Postoperative Delirium
Confusion Assessment Method (CAM) with delirium scored as 'present' (1) or 'absent' (0) based on question responses; CAM is considered positive based on the CAM algorithm: presence of acute onset or fluctuating course, inattention, and disorganized thinking or altered level of consciousness.
Perioperative Inflammatory Response
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.
Number of Patients Who Experienced Postoperative Complications
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.

Full Information

First Posted
November 4, 2015
Last Updated
September 28, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02604459
Brief Title
Does Optimized General Anesthesia Care Reduce Postoperative Delirium?
Acronym
OPCare
Official Title
Does Optimized General Anesthesia Care Reduce Postoperative Delirium In Older Patients Undergoing Hip Fracture Repair?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Limited availability of subjects meeting inclusion criteria resulting in early termination (lack of funding) before meeting target enrollment.
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Anesthesia, Delirium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The individuals assessing the patients for delirium after surgery will be unaware of the treatment in the operating room.
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual general anesthesia care
Arm Type
Active Comparator
Arm Description
Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
Arm Title
Optimized general anesthesia care
Arm Type
Experimental
Arm Description
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.
Arm Title
Mini Mental State Exam
Arm Type
Active Comparator
Arm Description
Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
Arm Title
Tested and Excluded
Arm Type
Other
Arm Description
Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
Intervention Type
Device
Intervention Name(s)
cerebral oximeter (Fore-Sight)
Intervention Description
The cerebral oximeter will be monitored in the optimized care group and cerebral oxygenation will be maintained at 60% or higher.
Intervention Type
Device
Intervention Name(s)
depth of anesthesia monitor (BIS)
Intervention Description
The depth of anesthesia will be maintained between 40 and 60 in the optimized care group.
Intervention Type
Procedure
Intervention Name(s)
BP management
Intervention Description
The systolic blood pressure will be maintained within 20% of preoperative levels in the optimized care group.
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Intervention Description
General anesthesia will be used in both groups
Intervention Type
Drug
Intervention Name(s)
propofol
Other Intervention Name(s)
diprivan
Intervention Description
propofol per protocol
Intervention Type
Drug
Intervention Name(s)
fentanyl
Other Intervention Name(s)
sublimaze
Intervention Description
fentanyl per protocol
Intervention Type
Drug
Intervention Name(s)
sevoflurane
Other Intervention Name(s)
ultane
Intervention Description
maintenance of anesthesia with inhaled sevoflurane
Primary Outcome Measure Information:
Title
Severity of Postoperative Delirium
Description
Delirium Rating Scale-Revised-98 (DRS-R-98) is a 16-item clinician-rated scale with 13 severity items and 3 diagnostic items (maximum severity score of 39 points). Higher scores indicate more severe delirium; score of 0 indicates no delirium. Only the number of patients who had high scores on the DRS-R-98 are reported.
Time Frame
5 postoperative days
Secondary Outcome Measure Information:
Title
Number of Patients Who Presented With Postoperative Delirium
Description
Confusion Assessment Method (CAM) with delirium scored as 'present' (1) or 'absent' (0) based on question responses; CAM is considered positive based on the CAM algorithm: presence of acute onset or fluctuating course, inattention, and disorganized thinking or altered level of consciousness.
Time Frame
5 postoperative days
Title
Perioperative Inflammatory Response
Description
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.
Time Frame
preoperative, day of surgery, and postoperative day 2
Title
Number of Patients Who Experienced Postoperative Complications
Description
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.
Time Frame
3 months and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quinn L Johnson, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri Hospitals
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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