- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05644535
Cerebrospinal Fluid Gravity Correlation Analysis
Correlation Between Blood Biochemical Indicators and Cerebrospinal Fluid Gravity in Aged Patients
Study Overview
Status
Conditions
Detailed Description
Hip joint injury is one of the common injuries in the elderly, and hip arthroplasty is a treatment method that allows patients to get out of bed and return to social life as soon as possible. Currently, the common position for hip arthroplasty is the lateral position; and combined spinal and epidural anesthesia or subarachnoid anesthesia is also the common anesthesia method for hip arthroplasty. In the lateral position, the patient's affected limb is often on top and the healthy limb is on the bottom; the healthy side position is also the usual position for hip arthroplasty. In this position, it may be optimal to use a lighter specific gravity local anesthetic drug because it tends to anesthetize only the upper affected limb and does not require a return to the supine position after anesthesia due to changes in the plane of block, minimizing pain and hemodynamic fluctuations during anesthesia and position changes.
Currently, light specific gravity is more of a concept. Because in the available data, only the range of cerebrospinal fluid density of ordinary healthy adults is available, there is little literature and data to describe and analyze what the cerebrospinal fluid density of elderly patients actually is. Therefore, when we administer subarachnoid anesthesia to elderly patients, we cannot determine whether the dispensed local anesthetic drug is a light specific gravity.
In this study, we intend to collect cerebrospinal fluid from elderly patients who underwent hip arthroplasty under combined lumbar and rigid anesthesia or subarachnoid anesthesia, and measure the cerebrospinal fluid density in elderly patients, and observe whether there is a correlation between the above factors and cerebrospinal fluid density through the electronic medical record system to understand the patient's gender, blood glucose, blood biochemical electrolytes and routine blood levels; thus, we can better guide the use of lighter specific gravity drugs in clinical practice.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Zhiming Zhang
- Phone Number: +8613875555649
- Email: otc0735@163.com
Study Contact Backup
- Name: Yuan Qin
- Phone Number: 13657381087
- Email: uscqinyuan@163.com
Study Locations
-
-
Hunan
-
Chenzhou, Hunan, China, 423000
- Zhiming Zhang
-
Contact:
- Zhiming Zhang, M.D.
- Phone Number: +8613875555649
- Email: otc0735@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Receiving combined spinal and epidural anesthesia or subarachnoid anesthesia ASA Ⅰ or Ⅱ patients No significant neurological pathology No recent history of cerebral infarction No recent history of cerebral hemorrhage No central nervous system inflammation No spinal inflammatory disease No history of spinal surgery Patients who have given pre-operative informed written consent
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group A
Patients were aged 60-69 years
|
After obtaining the patient's cerebrospinal fluid specimen, the actual mass of the cerebrospinal fluid was measured by pipetting 1000 μL of cerebrospinal fluid specimen on an analytical balance using a pipette gun, and all specimens were measured three times and the average of the three times was taken as the final mass of 1000 μL of that specimen.
After the mass measurement, the residual cerebrospinal fluid was disposed of as medical waste.
The density of each specimen was obtained according to the density to mass conversion formula ρ=m/v.
After obtaining the patient's blood specimens, they were sent to the laboratory for blood routine examination.
After obtaining the patient's blood specimens, they were sent to the laboratory for blood electrolyte examination.
|
|
Group B
Patients were aged 70-79 years
|
After obtaining the patient's cerebrospinal fluid specimen, the actual mass of the cerebrospinal fluid was measured by pipetting 1000 μL of cerebrospinal fluid specimen on an analytical balance using a pipette gun, and all specimens were measured three times and the average of the three times was taken as the final mass of 1000 μL of that specimen.
After the mass measurement, the residual cerebrospinal fluid was disposed of as medical waste.
The density of each specimen was obtained according to the density to mass conversion formula ρ=m/v.
After obtaining the patient's blood specimens, they were sent to the laboratory for blood routine examination.
After obtaining the patient's blood specimens, they were sent to the laboratory for blood electrolyte examination.
|
|
Group C
Patients were aged 80-89 years
|
After obtaining the patient's cerebrospinal fluid specimen, the actual mass of the cerebrospinal fluid was measured by pipetting 1000 μL of cerebrospinal fluid specimen on an analytical balance using a pipette gun, and all specimens were measured three times and the average of the three times was taken as the final mass of 1000 μL of that specimen.
After the mass measurement, the residual cerebrospinal fluid was disposed of as medical waste.
The density of each specimen was obtained according to the density to mass conversion formula ρ=m/v.
After obtaining the patient's blood specimens, they were sent to the laboratory for blood routine examination.
After obtaining the patient's blood specimens, they were sent to the laboratory for blood electrolyte examination.
|
|
Group D
Patient age > 90 years
|
After obtaining the patient's cerebrospinal fluid specimen, the actual mass of the cerebrospinal fluid was measured by pipetting 1000 μL of cerebrospinal fluid specimen on an analytical balance using a pipette gun, and all specimens were measured three times and the average of the three times was taken as the final mass of 1000 μL of that specimen.
After the mass measurement, the residual cerebrospinal fluid was disposed of as medical waste.
The density of each specimen was obtained according to the density to mass conversion formula ρ=m/v.
After obtaining the patient's blood specimens, they were sent to the laboratory for blood routine examination.
After obtaining the patient's blood specimens, they were sent to the laboratory for blood electrolyte examination.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cerebrospinal fluid density
Time Frame: baseline (before anesthesia)
|
After obtaining the mass of cerebrospinal fluid, the density was calculated from ρ=m/v
|
baseline (before anesthesia)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood sugar
Time Frame: baseline (before anesthesia)
|
Plasma glucose level
|
baseline (before anesthesia)
|
|
Plasma K+ concentration
Time Frame: baseline (before anesthesia)
|
Plasma K+ concentration
|
baseline (before anesthesia)
|
|
Plasma Cl- concentration
Time Frame: baseline (before anesthesia)
|
Plasma Cl- concentration
|
baseline (before anesthesia)
|
|
WBC
Time Frame: baseline (before anesthesia)
|
Leukocyte concentration in blood
|
baseline (before anesthesia)
|
|
Neutrophil concentration in blood
Time Frame: baseline (before anesthesia)
|
Neutrophil concentration in blood
|
baseline (before anesthesia)
|
|
Lymphocyte concentration in blood
Time Frame: baseline (before anesthesia)
|
Lymphocyte concentration in blood
|
baseline (before anesthesia)
|
|
C-reactive protein (CRP)
Time Frame: baseline (before anesthesia)
|
C-reactive protein concentration in plasma
|
baseline (before anesthesia)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 202201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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