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Lumbar Plexus-sciatic Nerve Block With Sevoflurane on Cognitive Function in Elderly Patients After Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT03162861
Recruitment Status : Unknown
Verified May 2017 by Yanhong Guo, Qinghai University.
Recruitment status was:  Active, not recruiting
First Posted : May 22, 2017
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
Yanhong Guo, Qinghai University

Tracking Information
First Submitted Date  ICMJE April 26, 2017
First Posted Date  ICMJE May 22, 2017
Last Update Posted Date May 22, 2017
Actual Study Start Date  ICMJE January 2016
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2017)
Montreal Cognitive Assessment [ Time Frame: day 1 and day 3 after surgery ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lumbar Plexus-sciatic Nerve Block With Sevoflurane on Cognitive Function in Elderly Patients After Hip Arthroplasty
Official Title  ICMJE 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
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hip Arthropathy
Intervention  ICMJE
  • Drug: sevoflurane inhalation for anesthesia
    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.
    Other Name: sevoflurane group
  • Drug: propofol for anesthesia
    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.
    Other Name: propofol group
Study Arms  ICMJE
  • Experimental: the observation 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.
    Intervention: Drug: sevoflurane inhalation for anesthesia
  • Experimental: the control 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.
    Intervention: Drug: propofol for anesthesia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 18, 2017)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03162861
Other Study ID Numbers  ICMJE QinghaiUH_007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Yanhong Guo, Qinghai University
Study Sponsor  ICMJE Qinghai University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yanhong Guo, Ph.D Affiliated Hospital, Qinghai University
PRS Account Qinghai University
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP