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Opioid Analgesic

Tested and Excluded for Hip Fracture (OPCare Trial)

N/A
Waitlist Available
Led By Quinn L Johnson, MD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months and 1 year
Awards & highlights

OPCare Trial 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.

Eligible Conditions
  • Hip Fracture
  • Anesthesia
  • Delirium

OPCare Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months and 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Severity of Postoperative Delirium
Secondary outcome measures
Number of Patients Who Experienced Postoperative Complications
Number of Patients Who Presented With Postoperative Delirium
Perioperative Inflammatory Response

OPCare Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Tested and ExcludedExperimental Treatment4 Interventions
Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
Group II: Optimized general anesthesia careExperimental Treatment7 Interventions
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.
Group III: Mini Mental State ExamActive Control4 Interventions
Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
Group IV: Usual general anesthesia careActive Control4 Interventions
Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sevoflurane
FDA approved
Fentanyl
FDA approved
General anesthesia
2018
Completed Phase 4
~5550
Propofol
FDA approved

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
361 Previous Clinical Trials
627,849 Total Patients Enrolled
Quinn L Johnson, MDPrincipal InvestigatorUniversity of Missouri-Columbia
Terri G Monk, MDPrincipal InvestigatorUniversity of Missouri-Columbia
3 Previous Clinical Trials
364 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Does Optimized General Anesthesia Care Reduce Postoperative Delirium?
Quinn Johnson 2015. "Does Optimized General Anesthesia Care Reduce Postoperative Delirium?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02604459.
~15 spots leftby Apr 2025
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