Femoral Neck FracturesPhase 4NCT01934049
Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty
A Phase 4 study testing hip arthroplasty and Total Intravenous Anesthesia and Peripheral nerve blocks in people with Femoral Neck Fractures and Postoperative Complications, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Hip fractures incidence grows rapidly with the aging of the population. After indicated surgical treatment, hip fracture patients experience high rates of postoperative complications, postoperative delirium (PD), postoperative cognitive dysfunction (POCD), leading to poor postoperative recovery during hospitalization… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Femoral Neck Fractures, Postoperative Complications, Inflammatory Response
- What is being tested?
- hip arthroplasty and Total Intravenous Anesthesia and Peripheral nerve blocks
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Jun 2014
- Phase
- Phase 4
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age > 75years old
- Patients with femoral neck fractures
- Undergoing hip hemi-arthroplasty surgery
- American Society of Anesthesiologists (ASA) physical status II-IV
- MoCA being more than 23
Who cannot join
- Patient refusal to participate in the study
- Patient refusal or failure of regional block
- allergic to local anesthetics or general anesthetics
- history of opioid dependence
- contraindications to nerve blocks (coagulation defects, infection at puncture site, preexisting neurological deficits in the lower extremities)
- current severe psychiatric disease or alcoholism or drug dependence
- severe visual or auditory disorder
Trial locations and contacts
1 site in 1 country.
yuan weixiu, ph.d contact
China1 site, 1 recruiting
- Recruiting
Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital
Beijing, 100853
Zhang Hong, ph.d, 0086-10-66937462, mazuimao301@yahoo.com.cn
Yuan Weixiu, Ph.d, 0086-10-66938052, yuanweixiu301@126.com
About this study
Official title: The Effect of Dexmedetomidine on Postoperative Recovery in Elderly Patients With Femoral Neck Fracture Undergoing Hip Hemi-arthroplasty
Hip fractures incidence grows rapidly with the aging of the population. After indicated surgical treatment, hip fracture patients experience high rates of postoperative complications, postoperative delirium (PD), postoperative cognitive dysfunction (POCD), leading to poor postoperative recovery during hospitalization, which can cause disability, distress for both patients and their families, are associated with other medical complications and account for significant additional health care costs. We currently use dexmedetomidine in elderly patients with hip fractures undergoing hip hemi-arthroplasty in order to improve postoperative recovery and prevent and treating PD and POCD.
Dexmedetomidine is a drug used for sedation in critically ill patients that provides some pain relief and controls the bodies response to stress. The sedation produced by dexmedetomidine appears more similar to natural sleep than any other drug used for anesthesia and postoperative sedation. Data suggesting that dexmedetomidine can prevent delirium following cardiac surgery and the developing understanding of the causes of PD and POCD suggest that dexmedetomidine will be particularly effective.
- Conditions
- Femoral Neck Fractures, Postoperative Complications, Inflammatory Response, Postoperative Delirium, Postoperative Cognitive Dysfunction
- Being tested
- hip arthroplasty, Total Intravenous Anesthesia and Peripheral nerve blocks
- Medical subject headings
- Femoral Neck Fractures, Postoperative Complications, Emergence Delirium, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hip arthroplastyProcedure or surgery
Every patient with femoral neck fractures must undergo hip hemi-arthroplasty.
Total Intravenous Anesthesia and Peripheral nerve blocksDrug
Every patient receives Peripheral nerve blocks and Total Intravenous Anesthesia with propofol
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | Dexmedetomidine in dex group is administered as 1ug/kg by intravenous infusion 10 min and then 0.6 ug/kg until 30 minutes before the operation finishes. Receives: Procedure: hip arthroplasty; Drug: Total Intravenous Anesthesia and Peripheral nerve blocks |
| Saline | Placebo comparator | Participants in con group receive placebo(saline) as the same dose at the same time as dex group. Receives: Procedure: hip arthroplasty; Drug: Total Intravenous Anesthesia and Peripheral nerve blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative cognitive dysfunction(POCD)
POCD is assessed by Montreal Cognitive Assessment(MoCA), which was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration,executive functions, memory, language,visuoconstructional skills, conceptual thinking,calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal.
Measured: 7days
Secondary outcomes (2)
Postoperative recovery
The postoperative recovery is assessed by the Post-operative Quality Recovery Scale (PQRS),which is a research tool designed to measure postoperative quality of recovery in multiple domains and over multiple time periods. Recovery domains include physiological, emotive (depression and anxiety), nociceptive (pain and nausea), cognitive, activities of daily living (ADL), and overall patient perspective (including satisfaction).
Measured: 7days
Postoperative Delirium(PD)
The postoperative Delirium is assessed by the Confusion Assessment Method (CAM)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junle Liu, Chinese PLA General Hospital
- Investigators
- zhang hong, ph.d, Study chair, Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934049
- Sponsor's protocol ID
- Dex-THR
- Status last verified
- Sep 2013
- First submitted
- 21 Aug 2013
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine on Postoperative Recovery in Elderly Patients With Femoral Neck Fracture Undergoing Hip Hemi-arthroplasty
- ClinicalTrials.gov ID
- NCT01934049
- Acronym / sponsor ID
- Dex-THR
- Conditions
- Femoral Neck Fractures, Postoperative Complications, Inflammatory Response, Postoperative Delirium, Postoperative Cognitive Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 4 Sep 2013 (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.
Hip fractures incidence grows rapidly with the aging of the population. After indicated surgical treatment, hip fracture patients experience high rates of postoperative complications, postoperative delirium (PD), postoperative cognitive dysfunction (POCD), leading to poor postoperative recovery during hospitalization, which can cause disability, distress for both patients and their families, are associated with other medical complications and account for significant additional health care costs. We currently use dexmedetomidine in elderly patients with hip fractures undergoing hip hemi-arthroplasty in order to improve postoperative recovery and prevent and treating PD and POCD.
Dexmedetomidine is a drug used for sedation in critically ill patients that provides some pain relief and controls the bodies response to stress. The sedation produced by dexmedetomidine appears more similar to natural sleep than any other drug used for anesthesia and postoperative sedation. Data suggesting that dexmedetomidine can prevent delirium following cardiac surgery and the developing understanding of the causes of PD and POCD suggest that dexmedetomidine will be particularly effective.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Procedure: hip arthroplasty, Drug: Total Intravenous Anesthesia and Peripheral nerve blocksDexmedetomidine in dex group is administered as 1ug/kg by intravenous infusion 10 min and then 0.6 ug/kg until 30 minutes before the operation finishes. |
| Saline | Placebo comparator | Procedure: hip arthroplasty, Drug: Total Intravenous Anesthesia and Peripheral nerve blocksParticipants in con group receive placebo(saline) as the same dose at the same time as dex group. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age > 75years old
- Patients with femoral neck fractures
- Undergoing hip hemi-arthroplasty surgery
- American Society of Anesthesiologists (ASA) physical status II-IV
- MoCA being more than 23
Key exclusion criteria (7 listed)
- Patient refusal to participate in the study
- Patient refusal or failure of regional block
- allergic to local anesthetics or general anesthetics
- history of opioid dependence
- contraindications to nerve blocks (coagulation defects, infection at puncture site, preexisting neurological deficits in the lower extremities)
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 |
|---|---|---|
| hip arthroplastyEvery patient with femoral neck fractures must undergo hip hemi-arthroplasty. | Procedure or surgery | Dexmedetomidine, Saline |
| Total Intravenous Anesthesia and Peripheral nerve blocksEvery patient receives Peripheral nerve blocks and Total Intravenous Anesthesia with propofol | Drug | Dexmedetomidine, Saline |
Primary outcome
postoperative cognitive dysfunction(POCD)
Time frame: 7days
POCD is assessed by Montreal Cognitive Assessment(MoCA), which was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration,executive functions, memory, language,visuoconstructional skills, conceptual thinking,calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal.
2 secondary outcomes
Postoperative recovery
Time frame: 7days
Postoperative Delirium(PD)
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
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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.
yuan weixiu, ph.d contact
zhang hong, ph.d study chair
Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hip arthroplasty and Total Intravenous Anesthesia and Peripheral nerve blocks in people with Femoral Neck Fractures and Postoperative Complications, run by Chinese PLA General Hospital at 1 site in China.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Sep 2013. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhang hong, ph.d (0086-10-66937462, mazuimao301@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative cognitive dysfunction(POCD) (time frame: 7days). 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 10 Sep 2013.