Postoperative ComplicationsNCT02190903
A Trial To Assess Risk of Delirium in Older Adults Undergoing Hip Fracture Surgery With Spinal or General Anesthesia
A study testing General endotracheal anesthesia and Regional (spinal) Anesthesia in people with Postoperative Complications and Hip Fracture, run by University of Pennsylvania at 1 site in United States.
Trial summary
This pilot project will address the gaps in knowledge regarding the effect of anesthetic technique on the risk of delirium through an adequately-powered trial employing standardized regimens for treatment and outcome assessment to test the hypothesis that use of spinal versus general anesthesia decreases the risk of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Hip Fracture, Delirium
- What is being tested?
- General endotracheal anesthesia and Regional (spinal) Anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Apr 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is aged 18 and older.
- Subject is scheduled to undergo surgical treatment of an acute femoral neck or pertrochanteric hip fracture.
- Subject can speak English
- Subject has ability to sign informed consent
Who cannot join
- Subject has a pathological or periprosthetic fracture.
- Subject has concurrent conditions anticipated at the time of admission to require surgical treatment (e.g. multiple trauma, acute cholecystitis).
- Subject has severe cognitive impairment, as evidenced by a Montreal Cognitive Assessment Score (MOCA) of 15 or less.
- Subject has clinical findings of delirium prior to surgery, as evidenced by a positive Confusion Assessment Method (CAM) evaluation;
- Subject has contraindications to spinal anesthesia or volatile general anesthetics.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hosptial of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Controlled Trial To Assess Risk of Delirium in Older Adults Undergoing Hip Fracture Surgery With Spinal or General Anesthesia
This pilot project will address the gaps in knowledge regarding the effect of anesthetic technique on the risk of delirium through an adequately-powered trial employing standardized regimens for treatment and outcome assessment to test the hypothesis that use of spinal versus general anesthesia decreases the risk of delirium after hip fracture surgery.
Read the detailed description
Objectives Overall objectives Overall Objectives Specific Aims
- To compare the effect of spinal versus general anesthesia on rates of postoperative delirium after hip fracture surgery. We hypothesize that rates of delirium after hip fracture surgery will be lower among patients receiving spinal versus general anesthesia.
- To develop, field-test, and conduct a qualitative evaluation of protocols and procedures for a planned multicenter trial to test the association of anesthesia technique with survival and recovery of function in activities of daily living ambulatory ability at six months after hip fracture.
Primary outcome variable(s) The primary outcome variable is the rate of delirium after hip fracture surgery.
Background Delirium, or a disturbance of consciousness and a change in cognition that develop over a short period of time, (1) complicates 2.6 million hospitalizations among U.S. adults aged 65 or older each year. (2,3) Patients who experience delirium during hospitalization face increased risks morbidity, mortality, and functional disability. (4) Each year, delirium accounts for $6.9 billion in Medicare hospital expenditures. (5) Delirium occurs in 35% to 65% of the 320,000 older U.S. adults hospitalized for hip fracture each year. (6) While adverse survival and functional outcomes are common after hip fracture, (7) a single episode of delirium doubles the odds of both new functional dependence and new ambulatory disability at six months after fracture, and triples the odds of death or new nursing home placement. (8) Compared to general endotracheal anesthesia, spinal anesthesia may decrease the incidence of postoperative delirium after hip fracture surgery. Small randomized trials of anesthesia type for hip fracture have suggested a 50% lower risk of acute confusion after hip fracture surgery with spinal anesthesia, (9) but the heterogeneity of outcome definitions and measurement strategies employed by past trials, along with their use of historical anesthesia practices limit their applicability to current practice.
As a result of these limitations, clinical equipoise continues to exist regarding the optimal anesthetic technique for hip fracture care. Compared to general anesthesia, spinal anesthesia may offer potential benefits not limited to decreased delirium. These may include decreased intraoperative blood loss, and decreased risks of postoperative thromboembolic events, respiratory infections and malignant hyperthermia. At the same time, spinal anesthesia may be associated with greater hypotension than general anesthesia, and may carry small risks of bleeding and infection at the site of the spinal injection and discomfort during block placement. Relative to spinal anesthesia, general anesthesia may offer benefits of hemodynamic stability. At present, while spinal anesthesia has been demonstrated in a retrospective observational study to be associated with lower in-hospital mortality after hip fracture (10), a meta-analysis of randomized trials was inconclusive with regard to mortality differences. (9) Reflecting this state of clinical equipoise patterns of anesthesia care differ widely by country and by provider, reflecting a large role of provider practice style in determining anesthesia care for hip fracture. For example, in a recent survey of UK anesthesiologists, 76% indicated that they routinely performed hip fracture surgeries with spinal anesthesia (11). In contrast, recent U.S. data suggest that approximately 80% of hip fracture surgeries are performed with general anesthesia, with wide variability in practice across hospitals.(10) While these variations may in part reflect differences in patient preferences, the current state of knowledge regarding the risks and benefits of differing types of anesthesia is inadequate to support appropriately informed medical decision-making by either patients or health care providers. The UKs national institute for Health and Care Excellence (NICE) strongly recommend further clinical trials to provide additional information regarding the clinical and cost effectiveness of differing anesthesia types for hip fracture, stating that they were unable to identify any recent randomised controlled trialsthat fully address this question and that the [available] evidence is old and does not reflect current practice.
Study Design Phase II
Design This is a randomized, controlled trial of spinal versus general anesthesia to test the effect of anesthesia type on rates of postoperative delirium after hip fracture surgery.
Study duration It is expected that this study will begin enrollment in June 2013. The enrollment of all subjects is projected to be completed in May 2014 with data analysis to follow. The study will hope to be completed by June 2015.
The length of participation for each subject will be about 5 days.
- Conditions
- Postoperative Complications, Hip Fracture, Delirium
- Being tested
- General endotracheal anesthesia, Regional (spinal) Anesthesia
- Keywords
- delirium, hip fracture, general anesthesia, spinal anesthesia, postoperative complications
- Medical subject headings
- Postoperative Complications, Hip Fractures, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General endotracheal anesthesiaOther
General Anesthesia
Patients randomized to receive general anesthesia induction of anesthesia with intravenous lidocaine, propofol, fentanyl citrate and vecuronium or cisatracurium, following dosing guidelines defined by protocol. Following tracheal intubation, anesthesia will be maintained with sevoflurane in oxygen and air as defined by protocol. End-tidal gas monitoring (for carbon dioxide and sevoflurane) and maintenance, monitoring, and reversal of neuromuscular blockade will be as per HUP and PPMC routine. Immediate postoperative analgesia will be via IV dilaudid dosed intraoperatively as defined by protocol.
Regional (spinal) AnesthesiaOther
Patients randomized to receive spinal anesthesia will undergo spinal blockade using standard techniques and medications dosed as per protocol, and will include hyperbaric bupivicaine or tetracaine, fentanyl citrate, and epinephrine; algorithms for management of spinal-related hypotension will be defined by protocol. Intraoperative sedation will be achieved via continuous intravenous propofol infusion; supplemental oxygen will be provided by nasal cannula or facemask as needed.
| Study group | Role | What they receive |
|---|---|---|
| General endotracheal anesthesia | Active comparator | Standard care general endotracheal anesthesia Receives: Other: General endotracheal anesthesia |
| Regional (spinal) anesthesia | Active comparator | Standard care spinal anesthesia Receives: Other: Regional (spinal) Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Postoperative Delirium After Hip Fracture Surgery
Delirium will be assessed by the Confusion Assessment Method Instrument (CAM), a validated method of assessing delirium based on the presence of both (1) an acute onset of signs and symptoms with a fluctuating course AND (2) inattention; PLUS (3) disorganized thinking OR (4) an altered level of consciousness.
Measured: Up to 5 days post hip fracture surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startOct 2013
- Primary completionApr 2015
- Study completionApr 2015
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.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Neuman, University of Pennsylvania
- Investigators
- Mark D Neuman, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190903
- Sponsor's protocol ID
- 818017
- Status last verified
- Jul 2018
- First submitted
- 30 Jun 2014
- Last updated
- 30 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
American Psychiatric Association. Delirium, Dementia, and Amnestic and Other Cognitive Disorders. In: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision). Washington, D.C.: American Psychiatric Association; 2000.
Russo CA, Elixhauser A. Hospitalizations in the Elderly Population, 2003. 2006 May. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #6. Available from http://www.ncbi.nlm.nih.gov/books/NBK63501/
PubMed 21938846Fong TG, Tulebaev SR, Inouye SK. Delirium in elderly adults: diagnosis, prevention and treatment. Nat Rev Neurol. 2009 Apr;5(4):210-20. doi: 10.1038/nrneurol.2009.24.
PubMed 19347026Inouye SK, Rushing JT, Foreman MD, Palmer RM, Pompei P. Does delirium contribute to poor hospital outcomes? A three-site epidemiologic study. J Gen Intern Med. 1998 Apr;13(4):234-42. doi: 10.1046/j.1525-1497.1998.00073.x.
PubMed 9565386Inouye SK. Delirium in older persons. N Engl J Med. 2006 Mar 16;354(11):1157-65. doi: 10.1056/NEJMra052321. No abstract available.
PubMed 16540616Blackman DK, Kamimoto LA, Smith SM. Overview: surveillance for selected public health indicators affecting older adults--United States. MMWR CDC Surveill Summ. 1999 Dec 17;48(8):1-6.
PubMed 10634268Hung WW, Egol KA, Zuckerman JD, Siu AL. Hip fracture management: tailoring care for the older patient. JAMA. 2012 May 23;307(20):2185-94. doi: 10.1001/jama.2012.4842.
PubMed 22618926Marcantonio ER, Flacker JM, Michaels M, Resnick NM. Delirium is independently associated with poor functional recovery after hip fracture. J Am Geriatr Soc. 2000 Jun;48(6):618-24. doi: 10.1111/j.1532-5415.2000.tb04718.x.
PubMed 10855596Parker MJ, Handoll HH, Griffiths R. Anaesthesia for hip fracture surgery in adults. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD000521. doi: 10.1002/14651858.CD000521.pub2.
PubMed 15494999Neuman MD, Silber JH, Elkassabany NM, Ludwig JM, Fleisher LA. Comparative effectiveness of regional versus general anesthesia for hip fracture surgery in adults. Anesthesiology. 2012 Jul;117(1):72-92. doi: 10.1097/ALN.0b013e3182545e7c.
PubMed 22713634Sandby-Thomas M, Sullivan G, Hall JE. A national survey into the peri-operative anaesthetic management of patients presenting for surgical correction of a fractured neck of femur. Anaesthesia. 2008 Mar;63(3):250-8. doi: 10.1111/j.1365-2044.2007.05328.x.
PubMed 18289230National Clinical Guideline Centre (UK). The Management of Hip Fracture in Adults [Internet]. London: Royal College of Physicians (UK); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK83014/
PubMed 22420011Sieber FE, Zakriya KJ, Gottschalk A, Blute MR, Lee HB, Rosenberg PB, Mears SC. Sedation depth during spinal anesthesia and the development of postoperative delirium in elderly patients undergoing hip fracture repair. Mayo Clin Proc. 2010 Jan;85(1):18-26. doi: 10.4065/mcp.2009.0469.
PubMed 20042557Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PubMed 1202204Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.
PubMed 2240918
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial To Assess Risk of Delirium in Older Adults Undergoing Hip Fracture Surgery With Spinal or General Anesthesia
- ClinicalTrials.gov ID
- NCT02190903
- Acronym / sponsor ID
- 818017
- Conditions
- Postoperative Complications, Hip Fracture, Delirium
- Keywords
- delirium, hip fracture, general anesthesia, spinal anesthesia, postoperative complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Posted 30 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot project will address the gaps in knowledge regarding the effect of anesthetic technique on the risk of delirium through an adequately-powered trial employing standardized regimens for treatment and outcome assessment to test the hypothesis that use of spinal versus general anesthesia decreases the risk of delirium after hip fracture surgery.
Detailed description
Objectives Overall objectives Overall Objectives Specific Aims
- To compare the effect of spinal versus general anesthesia on rates of postoperative delirium after hip fracture surgery. We hypothesize that rates of delirium after hip fracture surgery will be lower among patients receiving spinal versus general anesthesia.
- To develop, field-test, and conduct a qualitative evaluation of protocols and procedures for a planned multicenter trial to test the association of anesthesia technique with survival and recovery of function in activities of daily living ambulatory ability at six months after hip fracture.
Primary outcome variable(s) The primary outcome variable is the rate of delirium after hip fracture surgery.
Background Delirium, or a disturbance of consciousness and a change in cognition that develop over a short period of time, (1) complicates 2.6 million hospitalizations among U.S. adults aged 65 or older each year. (2,3) Patients who experience delirium during hospitalization face increased risks morbidity, mortality, and functional disability. (4) Each year, delirium accounts for $6.9 billion in Medicare hospital expenditures. (5) Delirium occurs in 35% to 65% of the 320,000 older U.S. adults hospitalized for hip fracture each year. (6) While adverse survival and functional outcomes are common after hip fracture, (7) a single episode of delirium doubles the odds of both new functional dependence and new ambulatory disability at six months after fracture, and triples the odds of death or new nursing home placement. (8) Compared to general endotracheal anesthesia, spinal anesthesia may decrease the incidence of postoperative delirium after hip fracture surgery. Small randomized trials of anesthesia type for hip fracture have suggested a 50% lower risk of acute confusion after hip fracture surgery with spinal anesthesia, (9) but the heterogeneity of outcome definitions and measurement strategies employed by past trials, along with their use of historical anesthesia practices limit their applicability to current practice.
As a result of these limitations, clinical equipoise continues to exist regarding the optimal anesthetic technique for hip fracture care. Compared to general anesthesia, spinal anesthesia may offer potential benefits not limited to decreased delirium. These may include decreased intraoperative blood loss, and decreased risks of postoperative thromboembolic events, respiratory infections and malignant hyperthermia. At the same time, spinal anesthesia may be associated with greater hypotension than general anesthesia, and may carry small risks of bleeding and infection at the site of the spinal injection and discomfort during block placement. Relative to spinal anesthesia, general anesthesia may offer benefits of hemodynamic stability. At present, while spinal anesthesia has been demonstrated in a retrospective observational study to be associated with lower in-hospital mortality after hip fracture (10), a meta-analysis of randomized trials was inconclusive with regard to mortality differences. (9) Reflecting this state of clinical equipoise patterns of anesthesia care differ widely by country and by provider, reflecting a large role of provider practice style in determining anesthesia care for hip fracture. For example, in a recent survey of UK anesthesiologists, 76% indicated that they routinely performed hip fracture surgeries with spinal anesthesia (11). In contrast, recent U.S. data suggest that approximately 80% of hip fracture surgeries are performed with general anesthesia, with wide variability in practice across hospitals.(10) While these variations may in part reflect differences in patient preferences, the current state of knowledge regarding the risks and benefits of differing types of anesthesia is inadequate to support appropriately informed medical decision-making by either patients or health care providers. The UKs national institute for Health and Care Excellence (NICE) strongly recommend further clinical trials to provide additional information regarding the clinical and cost effectiveness of differing anesthesia types for hip fracture, stating that they were unable to identify any recent randomised controlled trialsthat fully address this question and that the [available] evidence is old and does not reflect current practice.
Study Design Phase II
Design This is a randomized, controlled trial of spinal versus general anesthesia to test the effect of anesthesia type on rates of postoperative delirium after hip fracture surgery.
Study duration It is expected that this study will begin enrollment in June 2013. The enrollment of all subjects is projected to be completed in May 2014 with data analysis to follow. The study will hope to be completed by June 2015.
The length of participation for each subject will be about 5 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General endotracheal anesthesia | Active comparator | Other: General endotracheal anesthesiaStandard care general endotracheal anesthesia |
| Regional (spinal) anesthesia | Active comparator | Other: Regional (spinal) AnesthesiaStandard care spinal anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is aged 18 and older.
- Subject is scheduled to undergo surgical treatment of an acute femoral neck or pertrochanteric hip fracture.
- Subject can speak English
- Subject has ability to sign informed consent
Key exclusion criteria (5 listed)
- Subject has a pathological or periprosthetic fracture.
- Subject has concurrent conditions anticipated at the time of admission to require surgical treatment (e.g. multiple trauma, acute cholecystitis).
- Subject has severe cognitive impairment, as evidenced by a Montreal Cognitive Assessment Score (MOCA) of 15 or less.
- Subject has clinical findings of delirium prior to surgery, as evidenced by a positive Confusion Assessment Method (CAM) evaluation;
- Subject has contraindications to spinal anesthesia or volatile general anesthetics.
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 |
|---|---|---|
| General endotracheal anesthesiaGeneral Anesthesia Patients randomized to receive general anesthesia induction of anesthesia with intravenous lidocaine, propofol, fentanyl citrate and vecuronium or cisatracurium, following dosing guidelines defined by protocol. Following tracheal intubation, anesthesia will be maintained with sevoflurane in oxygen and air as defined by protocol. End-tidal gas monitoring (for carbon dioxide and sevoflurane) and maintenance, monitoring, and reversal of neuromuscular blockade will be as per HUP and PPMC routine. Immediate postoperative analgesia will be via IV dilaudid dosed intraoperatively as defined by protocol. | Other | General endotracheal anesthesia |
| Regional (spinal) AnesthesiaPatients randomized to receive spinal anesthesia will undergo spinal blockade using standard techniques and medications dosed as per protocol, and will include hyperbaric bupivicaine or tetracaine, fentanyl citrate, and epinephrine; algorithms for management of spinal-related hypotension will be defined by protocol. Intraoperative sedation will be achieved via continuous intravenous propofol infusion; supplemental oxygen will be provided by nasal cannula or facemask as needed. | Other | Regional (spinal) anesthesia |
Primary outcome
Number of Participants With Postoperative Delirium After Hip Fracture Surgery
Time frame: Up to 5 days post hip fracture surgery
Delirium will be assessed by the Confusion Assessment Method Instrument (CAM), a validated method of assessing delirium based on the presence of both (1) an acute onset of signs and symptoms with a fluctuating course AND (2) inattention; PLUS (3) disorganized thinking OR (4) an altered level of consciousness.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundAmerican Psychiatric Association. Delirium, Dementia, and Amnestic and Other Cognitive Disorders. In: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision). Washington, D.C.: American Psychiatric Association; 2000.
- Background: PubMed 21938846Russo CA, Elixhauser A. Hospitalizations in the Elderly Population, 2003. 2006 May. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #6. Available from http://www.ncbi.nlm.nih.gov/books/NBK63501/
- Background: PubMed 19347026Fong TG, Tulebaev SR, Inouye SK. Delirium in elderly adults: diagnosis, prevention and treatment. Nat Rev Neurol. 2009 Apr;5(4):210-20. doi: 10.1038/nrneurol.2009.24.
- Background: PubMed 9565386Inouye SK, Rushing JT, Foreman MD, Palmer RM, Pompei P. Does delirium contribute to poor hospital outcomes? A three-site epidemiologic study. J Gen Intern Med. 1998 Apr;13(4):234-42. doi: 10.1046/j.1525-1497.1998.00073.x.
- Background: PubMed 16540616Inouye SK. Delirium in older persons. N Engl J Med. 2006 Mar 16;354(11):1157-65. doi: 10.1056/NEJMra052321. No abstract available.
- Background: PubMed 10634268Blackman DK, Kamimoto LA, Smith SM. Overview: surveillance for selected public health indicators affecting older adults--United States. MMWR CDC Surveill Summ. 1999 Dec 17;48(8):1-6.
- Background: PubMed 22618926Hung WW, Egol KA, Zuckerman JD, Siu AL. Hip fracture management: tailoring care for the older patient. JAMA. 2012 May 23;307(20):2185-94. doi: 10.1001/jama.2012.4842.
- Background: PubMed 10855596Marcantonio ER, Flacker JM, Michaels M, Resnick NM. Delirium is independently associated with poor functional recovery after hip fracture. J Am Geriatr Soc. 2000 Jun;48(6):618-24. doi: 10.1111/j.1532-5415.2000.tb04718.x.
- Background: PubMed 15494999Parker MJ, Handoll HH, Griffiths R. Anaesthesia for hip fracture surgery in adults. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD000521. doi: 10.1002/14651858.CD000521.pub2.
- Background: PubMed 22713634Neuman MD, Silber JH, Elkassabany NM, Ludwig JM, Fleisher LA. Comparative effectiveness of regional versus general anesthesia for hip fracture surgery in adults. Anesthesiology. 2012 Jul;117(1):72-92. doi: 10.1097/ALN.0b013e3182545e7c.
- Background: PubMed 18289230Sandby-Thomas M, Sullivan G, Hall JE. A national survey into the peri-operative anaesthetic management of patients presenting for surgical correction of a fractured neck of femur. Anaesthesia. 2008 Mar;63(3):250-8. doi: 10.1111/j.1365-2044.2007.05328.x.
- Background: PubMed 22420011National Clinical Guideline Centre (UK). The Management of Hip Fracture in Adults [Internet]. London: Royal College of Physicians (UK); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK83014/
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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.
Mark D Neuman principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General endotracheal anesthesia and Regional (spinal) Anesthesia in people with Postoperative Complications and Hip Fracture, run by University of Pennsylvania 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 30 Jul 2018. 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 30 Jul 2018). 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?
Number of Participants With Postoperative Delirium After Hip Fracture Surgery (time frame: Up to 5 days post hip fracture surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02190903, which also lists 21 linked publications.
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 30 Jul 2018.