Hip ArthropathyNCT03162861
Lumbar Plexus-sciatic Nerve Block With Sevoflurane on Cognitive Function in Elderly Patients After Hip Arthroplasty
A study testing sevoflurane inhalation for anesthesia and propofol for anesthesia in people with Hip Arthropathy, run by Qinghai University.
Trial summary
To assume that lumbar plexus-sciatic nerve block combined with sevoflurane can effectively diminish the incidence of cognitive dysfunction in elderly patients after hip arthroplasty. Read more about this study
- Who is it for?
- Ages 60 to 70 years
- Conditions the study is for
- Hip Arthropathy
- What is being tested?
- sevoflurane inhalation for anesthesia and propofol for anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2018
- 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 60 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: 60-70 years
- American Society of Anesthesiologists (ASA) classification: Class II and class III
- Unilateral hip arthroplasty
- Educational level: Junior high school and above, no cognitive dysfunction before surgery
- Hip joint disease treatment for the first time
- All patients or family members signed the informed consent
Who cannot join
- Nervous system disease or psychosis
- Allergy to anesthesia
- Poor compliance
- Cardiovascular system disease, severe primary liver and kidney diseases
- Other diseases affecting cognitive function or cognitive dysfunction
About this study
Official title: Effects of Lumbar Plexus-sciatic Nerve Block Combined With Sevoflurane on Cognitive Function in Elderly Patients After Hip Arthroplasty: Study Protocol for a Prospective, Single-center, Open-label, Randomized, Controlled, Clinical Trial
To assume that lumbar plexus-sciatic nerve block combined with sevoflurane can effectively diminish the incidence of cognitive dysfunction in elderly patients after hip arthroplasty.
Read the detailed description
History and current related studies Elderly patients after total hip arthroplasty often experience postoperative cognitive dysfunction (POCD) and disorders of brain function, such as memories, memory storage and concentration, perception and behavioral disorders. POCD is often transient, can be effectively controlled if measures can be taken timely; otherwise, POCD can become permanent, which may greatly affect the patient's quality of life. At present, pathogenesis and therapeutic effect of POCD are not clear in elderly patients undergoing total hip arthroplasty.
With the help of a nerve stimulator, lumbar plexus combined with sciatic nerve block achieves the precise positioning of the nerve puncture site, and achieves unilateral limb complete anesthesia. The scope of the block is limited, and it has little influence on circulation. Lumbar plexus and sacral sciatic nerve block can effectively suppress stress response to surgery and pain and improve cognitive dysfunction in patients after surgery. Basic fibroblast growth factor (bFGF) has been shown to be associated with cognitive function. The decreased bFGF expression can directly affect the function of nerve cells and cause a decrease in cognitive ability. Sevoflurane can improve cognitive dysfunction after surgery. However, whether sevoflurance can reduce the occurrence of POCD after hip arthroplasty has not been reported.
Adverse events
- To record adverse events, including incision pain, waist-dorsal muscle pain, spinal cord and nerve injury, hypotension, nausea and vomiting, dyspnea, and bradycardia.
- If severe adverse events occur, investigators will report details including the date of occurrence and measures taken to treat the adverse events to the principle investigator and the institutional review board within 24 hours.
Data collection, management, analysis, open access
- Data collection: Case report forms will be collected, processed using Epidata software (Epidata Association, Odense, Denmark), collated, and then recorded electronically by data managers using a double-data entry strategy.
- Data management: The locked electronic database will be accessible and locked only by the project manager. This arrangement will not be altered. The Affiliated Hospital of Qinghai University, China will preserve all of the data regarding this trial.
- Data analysis: A professional statistician will statistically analyze the electronic database and will create an outcome analysis report that will be submitted to the lead researchers. An independent data monitoring committee will supervise and manage the trial data, ensuring a scientific and stringent trial that yields accurate and complete data.
- Data open access: Anonymized trial data will be published at www.figshare.com.
Statistical analysis
- Statistical analysis will be performed using SPSS 19.0 software (IBM, Armonk, NY, USA) and will follow the intention-to-treat principle.
- Measurement data will be normally distributed and expressed as the mean ± standard deviation. Count data will be expressed as constituent ratio or rate.
- bFGF expression, Mini-Mental State Examination (MMSE) score and Montreal Cognitive Assessment (MoCA) score in both groups will be compared using two-sample t-test. Above indexes at three time points in the same group will be will be compared using repeated measures analysis of variance. The incidence of adverse reactions in both groups will be compared using Pearson X2 test.
- The correlation between serum bFGF expression and cognitive function will be analyzed using Pearson correlation analysis.
- The significance level will be α = 0.05.
- Conditions
- Hip Arthropathy
- Being tested
- sevoflurane inhalation for anesthesia, propofol for anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sevoflurane inhalation for anesthesiaDrug
Also called sevoflurane group
The elderly patients undergoing unilateral total hip arthroplasty will be randomized to assigned to the observation group. In the observation group, tracheal intubation will be conducted for general anesthesia after lumbar plexus-sciatic nerve block, accompanying sevoflurane inhalation for anesthesia maintenance.
propofol for anesthesiaDrug
Also called propofol group
The elderly patients undergoing unilateral total hip arthroplasty will be randomized to assigned to the control group. In the control group, tracheal intubation will be conducted for general anesthesia, accompanying intravenous administration of propofol for anesthesia maintenance.
| Study group | Role | What they receive |
|---|---|---|
| the observation group | Experimental | The elderly patients undergoing unilateral total hip arthroplasty will be randomized to assigned to the observation group. In the observation group, tracheal intubation will be conducted for general anesthesia after lumbar plexus-sciatic nerve block, accompanying sevoflurane inhalation for anesthesia maintenance. Receives: Drug: sevoflurane inhalation for anesthesia |
| the control group | Experimental | The elderly patients undergoing unilateral total hip arthroplasty will be randomized to assigned to the control group. In the control group, tracheal intubation will be conducted for general anesthesia, accompanying intravenous administration of propofol for anesthesia maintenance. Receives: Drug: propofol for anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination
To assess cognitive function. Mini-Mental State Examination (MMSE) items include memory, attention and computing ability, orientation, recall ability and language skill. Score range: 0-30. MMSE score < 25 is considered as cognitive dysfunction. All of the above tests will be performed by the same professional attending physician in patients with mental emotional stability.
Measured: Change from Baseline Mini-Mental State Examination at 3 day
Secondary outcomes (1)
Montreal Cognitive Assessment
To assess cognitive function. Montreal Cognitive Assessment (MoCA) items include execution and visual space function, language expression, attention, naming, delayed recall, abstract thinking, and orientation. Score range: 0-30. MoCA score < 26 is considered as cognitive dysfunction. All of the above tests will be performed by the same professional attending physician in patients with mental emotional stability.
Measured: day 1 and day 3 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study startJan 2016
- Primary completionJun 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthropathyStudies 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
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qinghai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Guo, Qinghai University
- Investigators
- Yanhong Guo, Ph.D, Principal investigator, Affiliated Hospital, Qinghai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162861
- Sponsor's protocol ID
- QinghaiUH_007
- Status last verified
- May 2017
- First submitted
- 26 Apr 2017
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lumbar Plexus-sciatic Nerve Block Combined With Sevoflurane on Cognitive Function in Elderly Patients After Hip Arthroplasty: Study Protocol for a Prospective, Single-center, Open-label, Randomized, Controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT03162861
- Acronym / sponsor ID
- QinghaiUH_007
- Conditions
- Hip Arthropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Qinghai UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 May 2017 (actual)
- 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.
To assume that lumbar plexus-sciatic nerve block combined with sevoflurane can effectively diminish the incidence of cognitive dysfunction in elderly patients after hip arthroplasty.
Detailed description
History and current related studies Elderly patients after total hip arthroplasty often experience postoperative cognitive dysfunction (POCD) and disorders of brain function, such as memories, memory storage and concentration, perception and behavioral disorders. POCD is often transient, can be effectively controlled if measures can be taken timely; otherwise, POCD can become permanent, which may greatly affect the patient's quality of life. At present, pathogenesis and therapeutic effect of POCD are not clear in elderly patients undergoing total hip arthroplasty.
With the help of a nerve stimulator, lumbar plexus combined with sciatic nerve block achieves the precise positioning of the nerve puncture site, and achieves unilateral limb complete anesthesia. The scope of the block is limited, and it has little influence on circulation. Lumbar plexus and sacral sciatic nerve block can effectively suppress stress response to surgery and pain and improve cognitive dysfunction in patients after surgery. Basic fibroblast growth factor (bFGF) has been shown to be associated with cognitive function. The decreased bFGF expression can directly affect the function of nerve cells and cause a decrease in cognitive ability. Sevoflurane can improve cognitive dysfunction after surgery. However, whether sevoflurance can reduce the occurrence of POCD after hip arthroplasty has not been reported.
Adverse events
- To record adverse events, including incision pain, waist-dorsal muscle pain, spinal cord and nerve injury, hypotension, nausea and vomiting, dyspnea, and bradycardia.
- If severe adverse events occur, investigators will report details including the date of occurrence and measures taken to treat the adverse events to the principle investigator and the institutional review board within 24 hours.
Data collection, management, analysis, open access
- Data collection: Case report forms will be collected, processed using Epidata software (Epidata Association, Odense, Denmark), collated, and then recorded electronically by data managers using a double-data entry strategy.
- Data management: The locked electronic database will be accessible and locked only by the project manager. This arrangement will not be altered. The Affiliated Hospital of Qinghai University, China will preserve all of the data regarding this trial.
- Data analysis: A professional statistician will statistically analyze the electronic database and will create an outcome analysis report that will be submitted to the lead researchers. An independent data monitoring committee will supervise and manage the trial data, ensuring a scientific and stringent trial that yields accurate and complete data.
- Data open access: Anonymized trial data will be published at www.figshare.com.
Statistical analysis
- Statistical analysis will be performed using SPSS 19.0 software (IBM, Armonk, NY, USA) and will follow the intention-to-treat principle.
- Measurement data will be normally distributed and expressed as the mean ± standard deviation. Count data will be expressed as constituent ratio or rate.
- bFGF expression, Mini-Mental State Examination (MMSE) score and Montreal Cognitive Assessment (MoCA) score in both groups will be compared using two-sample t-test. Above indexes at three time points in the same group will be will be compared using repeated measures analysis of variance. The incidence of adverse reactions in both groups will be compared using Pearson X2 test.
- The correlation between serum bFGF expression and cognitive function will be analyzed using Pearson correlation analysis.
- The significance level will be α = 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the observation group | Experimental | Drug: sevoflurane inhalation for anesthesiaThe elderly patients undergoing unilateral total hip arthroplasty will be randomized to assigned to the observation group. In the observation group, tracheal intubation will be conducted for general anesthesia after lumbar plexus-sciatic nerve block, accompanying sevoflurane inhalation for anesthesia maintenance. |
| the control group | Experimental | Drug: propofol for anesthesiaThe elderly patients undergoing unilateral total hip arthroplasty will be randomized to assigned to the control group. In the control group, tracheal intubation will be conducted for general anesthesia, accompanying intravenous administration of propofol for anesthesia maintenance. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age range: 60-70 years
- American Society of Anesthesiologists (ASA) classification: Class II and class III
- Unilateral hip arthroplasty
- Educational level: Junior high school and above, no cognitive dysfunction before surgery
- Hip joint disease treatment for the first time
Key exclusion criteria (5 listed)
- Nervous system disease or psychosis
- Allergy to anesthesia
- Poor compliance
- Cardiovascular system disease, severe primary liver and kidney diseases
- Other diseases affecting cognitive function or cognitive dysfunction
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 |
|---|---|---|
| sevoflurane inhalation for anesthesiaAlso: sevoflurane groupThe elderly patients undergoing unilateral total hip arthroplasty will be randomized to assigned to the observation group. In the observation group, tracheal intubation will be conducted for general anesthesia after lumbar plexus-sciatic nerve block, accompanying sevoflurane inhalation for anesthesia maintenance. | Drug | the observation group |
| propofol for anesthesiaAlso: propofol groupThe elderly patients undergoing unilateral total hip arthroplasty will be randomized to assigned to the control group. In the control group, tracheal intubation will be conducted for general anesthesia, accompanying intravenous administration of propofol for anesthesia maintenance. | Drug | the control group |
Primary outcome
Mini-Mental State Examination
Time frame: Change from Baseline Mini-Mental State Examination at 3 day
To assess cognitive function. Mini-Mental State Examination (MMSE) items include memory, attention and computing ability, orientation, recall ability and language skill. Score range: 0-30. MMSE score < 25 is considered as cognitive dysfunction. All of the above tests will be performed by the same professional attending physician in patients with mental emotional stability.
1 secondary outcome
Montreal Cognitive Assessment
Time frame: day 1 and day 3 after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Yanhong Guo, Ph.D principal investigator
Affiliated Hospital, Qinghai University
Questions about this trial
What is this clinical trial studying?
A study testing sevoflurane inhalation for anesthesia and propofol for anesthesia in people with Hip Arthropathy, run by Qinghai University.
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 6 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: status not confirmed, as of the sponsor's last update on 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Mini-Mental State Examination (time frame: Change from Baseline Mini-Mental State Examination at 3 day). 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 22 May 2017.