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

Does Optimized General Anesthesia Care Reduce Postoperative Delirium In Older Patients Undergoing Hip Fracture Repair?

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.

Study Overview

• Status: Terminated
• Conditions: Delirium; Hip Fractures; Anesthesia
• Intervention / Treatment: Procedure: General anesthesia; Drug: propofol; Drug: fentanyl; Drug: sevoflurane; Device: cerebral oximeter (Fore-Sight); Device: depth of anesthesia monitor (BIS); Procedure: BP management

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
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Terri G Monk, MD; Phone Number: 5738822568; Email: monkt@health.missouri.edu
• Study Contact Backup: Name: Adam Zino, MPh; Phone Number: 57388222568; Email: zinoa@health.missouri.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65203
      • University of Missouri Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: diprivan; Drug: fentanyl; fentanyl per protocol; Other Names: sublimaze; Drug: sevoflurane; maintenance of anesthesia with inhaled sevoflurane; Other Names: 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.	Procedure: General anesthesia; General anesthesia will be used in both groups; Drug: propofol; propofol per protocol; Other Names: diprivan; Drug: fentanyl; fentanyl per protocol; Other Names: sublimaze; Drug: sevoflurane; maintenance of anesthesia with inhaled sevoflurane; Other Names: ultane; 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.
Active Comparator: Mini Mental State Exam; 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 Names: diprivan; Drug: fentanyl; fentanyl per protocol; Other Names: sublimaze; Drug: sevoflurane; maintenance of anesthesia with inhaled sevoflurane; Other Names: ultane
Other: Tested and Excluded; 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 Names: diprivan; Drug: fentanyl; fentanyl per protocol; Other Names: sublimaze; Drug: sevoflurane; maintenance of anesthesia with inhaled sevoflurane; Other Names: ultane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 postoperative days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 postoperative days
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.	preoperative, day of surgery, and postoperative day 2
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.	3 months and 1 year

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Quinn L Johnson, MD, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): February 28, 2018

Study Registration Dates

• First Submitted: November 4, 2015
• First Submitted That Met QC Criteria: November 12, 2015
• First Posted (Estimated): November 13, 2015

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Leg Injuries; Femoral Fractures; Hip Injuries; Delirium; Emergence Delirium; Hip Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Platelet Aggregation Inhibitors; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Inhalation; Anesthetics; Fentanyl; Propofol; Sevoflurane
• Other Study ID Numbers: 1212915

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO