Does Optimized General Anesthesia Care Reduce Postoperative Delirium?

NCT02604459 | Terminated Results

• 1 other identifier: 1212915
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures; Anesthesia; Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Patients Who Presented With Postoperative Delirium

  5 postoperative days

• Perioperative Inflammatory Response

  preoperative, day of surgery, and postoperative day 2

• Number of Patients Who Experienced Postoperative Complications

  3 months and 1 year

Study Arms (4)

Usual general anesthesia care

ACTIVE COMPARATOR

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; Drug: propofol; Drug: fentanyl; Drug: sevoflurane

Optimized general anesthesia care

EXPERIMENTAL

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); Device: depth of anesthesia monitor (BIS); Procedure: BP management; Procedure: General anesthesia; Drug: propofol; Drug: fentanyl; Drug: sevoflurane

Mini Mental State Exam

ACTIVE COMPARATOR

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; Drug: propofol; Drug: fentanyl; Drug: sevoflurane

Tested and Excluded

OTHER

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; Drug: propofol; Drug: fentanyl; Drug: sevoflurane

Interventions

cerebral oximeter (Fore-Sight) DEVICE

The cerebral oximeter will be monitored in the optimized care group and cerebral oxygenation will be maintained at 60% or higher.

Optimized general anesthesia care

depth of anesthesia monitor (BIS) DEVICE

The depth of anesthesia will be maintained between 40 and 60 in the optimized care group.

Optimized general anesthesia care

BP management PROCEDURE

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

Optimized general anesthesia care

General anesthesia PROCEDURE

General anesthesia will be used in both groups

Mini Mental State Exam; Optimized general anesthesia care; Tested and Excluded; Usual general anesthesia care

propofol DRUG

propofol per protocol

Also known as: diprivan

Mini Mental State Exam; Optimized general anesthesia care; Tested and Excluded; Usual general anesthesia care

fentanyl DRUG

fentanyl per protocol

Also known as: sublimaze

Mini Mental State Exam; Optimized general anesthesia care; Tested and Excluded; Usual general anesthesia care

sevoflurane DRUG

maintenance of anesthesia with inhaled sevoflurane

Also known as: ultane

Mini Mental State Exam; Optimized general anesthesia care; Tested and Excluded; Usual general anesthesia care

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Hospitals

Columbia, Missouri, 65203, United States

Location

MeSH Terms

Conditions

Hip Fractures; Delirium

Interventions

Anesthesia, General; Propofol; Fentanyl; Sevoflurane

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Limitations and Caveats

Limited availability of subjects meeting inclusion criteria resulting in early termination (lack of funding) before meeting target enrollment.

Results Point of Contact

• Title: Dr. Quinn Johnson
• Organization: University of Missouri

johnsonql@health.missouri.edu

573-882-2568

Study Officials

• Quinn L Johnson, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The individuals assessing the patients for delirium after surgery will be unaware of the treatment in the operating room.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Anesthesiology

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 13, 2015
• Study Start: June 1, 2015
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: October 17, 2023
• Results First Posted: October 17, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)