Hip FracturesOPCareNCT02604459
Does Optimized General Anesthesia Care Reduce Postoperative Delirium?
A study testing cerebral oximeter (Fore-Sight), depth of anesthesia monitor (BIS) and BP management in people with Hip Fractures and Anesthesia, run by University of Missouri-Columbia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Anesthesia, Delirium
- What is being tested?
- cerebral oximeter (Fore-Sight), depth of anesthesia monitor (BIS) and BP management
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2015to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Inability to follow directions or comprehend the English language
- Severe uncorrected visual or auditory handicaps
- Delirium at screening or baseline
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Hospitals
Columbia, Missouri, 65203
About this study
Official title: 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.
Read the 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.
- Conditions
- Hip Fractures, Anesthesia, Delirium
- Being tested
- cerebral oximeter (Fore-Sight), depth of anesthesia monitor (BIS), BP management, General anesthesia, propofol
- Medical subject headings
- Hip Fractures, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
depth of anesthesia monitor (BIS)Device
The depth of anesthesia will be maintained between 40 and 60 in the optimized care group.
BP managementProcedure or surgery
The systolic blood pressure will be maintained within 20% of preoperative levels in the optimized care group.
General anesthesiaProcedure or surgery
General anesthesia will be used in both groups
propofolDrug
Also called diprivan
propofol per protocol
fentanylDrug
Also called sublimaze
fentanyl per protocol
sevofluraneDrug
Also called ultane
maintenance of anesthesia with inhaled sevoflurane
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: 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 Receives: Procedure: General anesthesia; Drug: propofol; Drug: fentanyl; Drug: sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 postoperative days
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 3 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study start1 Jun 2015
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Why it stopped: Limited availability of subjects meeting inclusion criteria resulting in early termination (lack of funding) before meeting target enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quinn Johnson, University of Missouri-Columbia
- Investigators
- Quinn L Johnson, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604459
- Sponsor's protocol ID
- 1212915
- Acronym
- OPCare
- Status last verified
- Sep 2023
- First submitted
- 4 Nov 2015
- Last updated
- 17 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Optimized General Anesthesia Care Reduce Postoperative Delirium In Older Patients Undergoing Hip Fracture Repair?
- ClinicalTrials.gov ID
- NCT02604459
- Acronym / sponsor ID
- OPCare / 1212915
- Conditions
- Hip Fractures, Anesthesia, Delirium
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Limited availability of subjects meeting inclusion criteria resulting in early termination (lack of funding) before meeting target enrollment.
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Posted 17 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Usual general anesthesia care | Active comparator | Procedure: General anesthesia, Drug: propofol, Drug: fentanyl, Drug: sevofluraneSubjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane |
| Optimized general anesthesia care | Experimental | Device: cerebral oximeter (Fore-Sight), Device: depth of anesthesia monitor (BIS), Procedure: BP management, Procedure: General anesthesia, Drug: propofol, Drug: fentanyl, Drug: sevofluraneThe 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. |
| Mini Mental State Exam | Active comparator | Procedure: General anesthesia, Drug: propofol, Drug: fentanyl, Drug: sevofluraneSubjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane |
| Tested and Excluded | Other | Procedure: General anesthesia, Drug: propofol, Drug: fentanyl, Drug: sevofluraneSubjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Inability to follow directions or comprehend the English language
- Severe uncorrected visual or auditory handicaps
- Delirium at screening or baseline
- Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Optimized general anesthesia care |
| depth of anesthesia monitor (BIS)The depth of anesthesia will be maintained between 40 and 60 in the optimized care group. | Device | Optimized general anesthesia care |
| BP managementThe systolic blood pressure will be maintained within 20% of preoperative levels in the optimized care group. | Procedure or surgery | Optimized general anesthesia care |
| General anesthesiaGeneral anesthesia will be used in both groups | Procedure or surgery | Mini Mental State Exam, Optimized general anesthesia care, Tested and Excluded, Usual general anesthesia care |
| propofolAlso: diprivanpropofol per protocol | Drug | Mini Mental State Exam, Optimized general anesthesia care, Tested and Excluded, Usual general anesthesia care |
| fentanylAlso: sublimazefentanyl per protocol | Drug | Mini Mental State Exam, Optimized general anesthesia care, Tested and Excluded, Usual general anesthesia care |
| sevofluraneAlso: ultanemaintenance of anesthesia with inhaled sevoflurane | Drug | Mini Mental State Exam, Optimized general anesthesia care, Tested and Excluded, Usual general anesthesia care |
Primary outcome
Severity of Postoperative Delirium
Time frame: 5 postoperative days
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.
3 secondary outcomes
Number of Patients Who Presented With Postoperative Delirium
Time frame: 5 postoperative days
Perioperative Inflammatory Response
Time frame: preoperative, day of surgery, and postoperative day 2
Number of Patients Who Experienced Postoperative Complications
Time frame: 3 months and 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quinn L Johnson, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cerebral oximeter (Fore-Sight), depth of anesthesia monitor (BIS) and BP management in people with Hip Fractures and Anesthesia, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Postoperative Delirium (time frame: 5 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.