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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05644535
Other study ID # 202201
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2022
Est. completion date May 31, 2023

Study information

Verified date November 2022
Source First People's Hospital of Chenzhou
Contact Zhiming Zhang
Phone +8613875555649
Email otc0735@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study was to measure cerebrospinal fluid density in aged patients and to see if there was a correlation between these factors and cerebrospinal fluid density by using the electronic medical record system to understand the patient's gender, blood glucose, blood biochemical electrolytes and blood levels.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date May 31, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - Receiving combined spinal and epidural anesthesia or subarachnoid anesthesia ASA ? or ? 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Cerebrospinal fluid densitometry
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 ?=m/v.
blood routine examination
After obtaining the patient's blood specimens, they were sent to the laboratory for blood routine examination.
Blood electrolyte examination
After obtaining the patient's blood specimens, they were sent to the laboratory for blood electrolyte examination.

Locations

Country Name City State
China Zhiming Zhang Chenzhou Hunan

Sponsors (1)

Lead Sponsor Collaborator
First People's Hospital of Chenzhou

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cerebrospinal fluid density After obtaining the mass of cerebrospinal fluid, the density was calculated from ?=m/v baseline (before anesthesia)
Secondary Blood sugar Plasma glucose level baseline (before anesthesia)
Secondary Plasma K+ concentration Plasma K+ concentration baseline (before anesthesia)
Secondary Plasma Cl- concentration Plasma Cl- concentration baseline (before anesthesia)
Secondary WBC Leukocyte concentration in blood baseline (before anesthesia)
Secondary Neutrophil concentration in blood Neutrophil concentration in blood baseline (before anesthesia)
Secondary Lymphocyte concentration in blood Lymphocyte concentration in blood baseline (before anesthesia)
Secondary C-reactive protein (CRP) C-reactive protein concentration in plasma baseline (before anesthesia)
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