Hip FractureNCT02458547
Effect of Anesthesia Technique on Outcome After Hip Fracture Surgery in Elderly Adult Patients
A study testing Desflurane, Propofol and Bupivacaine in people with Hip Fracture, run by Yonsei University at 1 site in South Korea.
Trial summary
Despite many previous studies, whether anesthetic technique will significantly affect overall patient outcome, morbidity and mortality in elderly hip fracture patients is controversial. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Desflurane, Propofol and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2015to 21 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 1. Patients older than 65 years scheduled for elective or emergency hip fracture surgery.
Who cannot join
- Patient refusal
- Inflammation or wound at puncture site, increased intracranial pressure, bleeding diathesis
- Allergies to propofol or its ingredients, soybeans or peanuts
- Patients with altered mental status
- Illiterate patients or foreigners
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System
Seoul, 120-752
About this study
Despite many previous studies, whether anesthetic technique will significantly affect overall patient outcome, morbidity and mortality in elderly hip fracture patients is controversial. Due to old age, poor patient condition and emergent clinical settings, patients undergoing surgical procedures for hip fracture management are often subject to poor postoperative outcome and high mortality rates. While many studies have reported that regional anesthesia leads to improved postoperative outcome after hip fracture surgery, others have concluded otherwise. Moreover, because the majority of these previous studies are retrospective cohorts or systemic reviews, there is a need for randomized clinical trials to provide high quality evidence. This study aims to compare patient outcome between three different anesthetic techniques in elderly patients undergoing surgery for hip fracture management by evaluating proinflammatory cytokines, chemistry lab testing and clinical outcome between general anesthesia with either desflurane or propofol-based TIVA and spinal anesthesia with bupivacaine.
- Conditions
- Hip Fracture
- Being tested
- Desflurane, Propofol, Bupivacaine
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Inhalation anesthesia with desflurane at age-adjusted MAC of 0.8~1.0
PropofolDrug
Total intravenous anesthesia with propofol target controlled infusion
BupivacaineDrug
Spinal anesthesia with 0.5% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group D | Experimental | General anesthesia with desflurane Receives: Drug: Desflurane |
| Group P | Active comparator | General anesthesia with propofol total intravenous anesthesia Receives: Drug: Propofol |
| Group S | Active comparator | Spinal anesthesia with 0.5% bupivacaine Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
HMGB1
Measured: from preoperative baseline to 72hours
IL-6
Measured: from preoperative baseline to 72hours
NT-proBNP
Measured: from preoperative baseline to 72hours
hemoglobin
Measured: from preoperative baseline to 72hours
total lymphocyte count
Measured: from preoperative baseline to 72hours
albumin
Measured: from preoperative baseline to 72hours
creatinine
Measured: from preoperative baseline to 72hours
potassium
Measured: from preoperative baseline to 72hours
troponin-T
Measured: from preoperative baseline to 72hours
CRP
Measured: from preoperative baseline to 72hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startMay 2015
- Primary completion21 Jan 2019
- Study completion21 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458547
- Sponsor's protocol ID
- 4-2015-0088
- Status last verified
- Mar 2019
- First submitted
- 26 May 2015
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anesthesia Technique on Outcome After Hip Fracture Surgery in Elderly Adult Patients
- ClinicalTrials.gov ID
- NCT02458547
- Acronym / sponsor ID
- 4-2015-0088
- Conditions
- Hip Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 21 Jan 2019 (actual)
- Study completion
- 21 Jan 2019 (actual)
- First posted
- 1 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite many previous studies, whether anesthetic technique will significantly affect overall patient outcome, morbidity and mortality in elderly hip fracture patients is controversial. Due to old age, poor patient condition and emergent clinical settings, patients undergoing surgical procedures for hip fracture management are often subject to poor postoperative outcome and high mortality rates. While many studies have reported that regional anesthesia leads to improved postoperative outcome after hip fracture surgery, others have concluded otherwise. Moreover, because the majority of these previous studies are retrospective cohorts or systemic reviews, there is a need for randomized clinical trials to provide high quality evidence. This study aims to compare patient outcome between three different anesthetic techniques in elderly patients undergoing surgery for hip fracture management by evaluating proinflammatory cytokines, chemistry lab testing and clinical outcome between general anesthesia with either desflurane or propofol-based TIVA and spinal anesthesia with bupivacaine.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group D | Experimental | Drug: DesfluraneGeneral anesthesia with desflurane |
| Group P | Active comparator | Drug: PropofolGeneral anesthesia with propofol total intravenous anesthesia |
| Group S | Active comparator | Drug: BupivacaineSpinal anesthesia with 0.5% bupivacaine |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 1. Patients older than 65 years scheduled for elective or emergency hip fracture surgery.
Key exclusion criteria (5 listed)
- Patient refusal
- Inflammation or wound at puncture site, increased intracranial pressure, bleeding diathesis
- Allergies to propofol or its ingredients, soybeans or peanuts
- Patients with altered mental status
- Illiterate patients or foreigners
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 |
|---|---|---|
| DesfluraneInhalation anesthesia with desflurane at age-adjusted MAC of 0.8~1.0 | Drug | Group D |
| PropofolTotal intravenous anesthesia with propofol target controlled infusion | Drug | Group P |
| BupivacaineSpinal anesthesia with 0.5% bupivacaine | Drug | Group S |
Primary outcome
HMGB1
Time frame: from preoperative baseline to 72hours
IL-6
Time frame: from preoperative baseline to 72hours
NT-proBNP
Time frame: from preoperative baseline to 72hours
hemoglobin
Time frame: from preoperative baseline to 72hours
total lymphocyte count
Time frame: from preoperative baseline to 72hours
albumin
Time frame: from preoperative baseline to 72hours
creatinine
Time frame: from preoperative baseline to 72hours
potassium
Time frame: from preoperative baseline to 72hours
troponin-T
Time frame: from preoperative baseline to 72hours
CRP
Time frame: from preoperative baseline to 72hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desflurane, Propofol and Bupivacaine in people with Hip Fracture, run by Yonsei University at 1 site in South Korea.
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 1 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 19 Mar 2019. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HMGB1 (time frame: from preoperative baseline to 72hours). The study lists 10 primary outcomes in all. 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 19 Mar 2019.