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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

  1. To record adverse events, including incision pain, waist-dorsal muscle pain, spinal cord and nerve injury, hypotension, nausea and vomiting, dyspnea, and bradycardia.
  2. 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

  1. 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.
  2. 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.
  3. 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.
  4. Data open access: Anonymized trial data will be published at www.figshare.com.

Statistical analysis

  1. Statistical analysis will be performed using SPSS 19.0 software (IBM, Armonk, NY, USA) and will follow the intention-to-treat principle.
  2. Measurement data will be normally distributed and expressed as the mean ± standard deviation. Count data will be expressed as constituent ratio or rate.
  3. 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.
  4. The correlation between serum bFGF expression and cognitive function will be analyzed using Pearson correlation analysis.
  5. 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 groups in NCT03162861
Study groupRoleWhat they receive
the observation groupExperimentalThe 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 groupExperimentalThe 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.

  1. 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)
  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.

  1. First posted22 May 2017
  2. Study startJan 2016
  3. Primary completionJun 2017 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

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)
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

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.

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