- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04071834
Observation of Blood Orphanin and Norepinephrine Levels in Diabetic Patients Under Subarachnoid Anesthesia
June 30, 2020 updated by: Zheng Guo, Second Hospital of Shanxi Medical University
Effect of Subarachnoid Anesthesia on Blood Orphanin and Norepinephrine in Diabetic Patients
This study aims to investigate the Influence of Intraspinal anesthesia to the concentrations of blood orphanin, norepinephrine in patients with diabetes mellitus.
We hope to explain the relationship between sensory and sympathetic nerves in diabetic patients undergoing intraspinal anesthesia.
Study Overview
Study Type
Observational
Enrollment (Actual)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanxi
-
Taiyuan, Shanxi, China, 030001
- Second of Shanxi Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
primary care clinic
Description
Inclusion Criteria:
- Patients undergoing lower limb surgery under spinal anesthesia
Exclusion Criteria:
- Emergency surgery
- The operation time is more than 3 hours
- Combined general anesthesia or nerve block anesthesia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Diabetes mellitus group
Diabetic patients undergoing spinal anesthesia for lower extremity surgery
|
Detection of blood orphanin and norepinephrine in patients
|
Non-diabetic group
Non-diabetic patients undergoing spinal anesthesia for lower extremity surgery
|
Detection of blood orphanin and norepinephrine in patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood orphanin concentration
Time Frame: 24 hours
|
Concentration of blood orphanin in patients before and after anesthesia
|
24 hours
|
Blood norepinephrine concentration
Time Frame: 24 hours
|
Concentration of blood norepinephrine in patients before and after anesthesia
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Actual)
April 2, 2020
Study Completion (Actual)
June 1, 2020
Study Registration Dates
First Submitted
August 26, 2019
First Submitted That Met QC Criteria
August 26, 2019
First Posted (Actual)
August 28, 2019
Study Record Updates
Last Update Posted (Actual)
July 2, 2020
Last Update Submitted That Met QC Criteria
June 30, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- hanyi20190826
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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