Changes of Cognitive Function and Orphanin FQ in Diabetic Patients Under General Anesthesia.

October 30, 2021 updated by: Zheng Guo, Second Hospital of Shanxi Medical University

Changes of Cognitive Function and Serum Levels of Calcium, Inflammatory Factors and Orphanin fQ in Diabetic Patients Under General Anesthesia

This study is the first to investigate the relationship between the changes of serum calcium and orphanin fq and the changes of cognitive function in patients with diabetes.To general anesthesia surgery of patients with diabetes as research group (group A), and to the non-general anesthesia surgery of diabetic patients as control group (group B), and then measured preoperative serum calcium ion concentration in patients with general anesthesia, inflammatory factor and solitary brown peptide content, intraoperative calcium ion concentration in serum, inflammatory factor and solitary brown peptide content, and postoperative serum calcium ion, inflammatory factor and solitary brown peptide content.Postoperative cognitive function were evaluated in both groups.Finally, the two groups of patients were screened and the inconsistent medical records were eliminated.Observation indicators: Endothelin, C-reactive protein, nitric oxide, interleukin-6, calcium ion concentration, orphanin fq concentration, glycated hemoglobin value and blood glucose value were observed before, during and after operation.The cognitive function of diabetic patients after surgery was observed. The cognitive function was evaluated with the cognitive function assessment scale 24 hours after surgery, respectively, and scores were obtained.Expected results: The comparison of clinical data between the control group and the study group showed that the cognitive function of patients in the study group was lower than that in the control group; the analysis showed that the serum content of orphanin fq in the study group was higher than that in the control group, the content of related inflammatory factors was higher than that in the control group, and the content of calcium ion was lower than that in the control group, and the differences were statistically significant.The results showed that when the cognitive function decreased, the content of orphanin fq increased, the corresponding inflammatory factors increased and the content of calcium decreased, indicating that the change of consciousness state and cognitive function were correlated with the orphanin fQ system.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objective: To investigate the changes of cognitive function in diabetic patients under general anesthesia, and test whether the changes of serum calcium ion, inflammatory factors and orphanin fQ are correlated. By prospective case study controlled study of diabetes (research group) general anesthesia surgery and the non-general anesthesia surgery of diabetes patients (control group), through the assessment of cognitive function and serum calcium ion, inflammation factors and the change of isolated brown peptide content to watch, in order to obtain reliable data to explore consciousness change changes of cognitive function in patients with diabetes and cognitive function in the process of the change of serum calcium ion concentration, the corresponding inflammation factors and solitary brown peptide content if there is a corresponding changes.The medical records of the patients were recorded. General information of the selected patients was recorded: gender, age, relevant medical history;Test results: blood glucose, hemoglobin , blood pressure;Drug use of patients: blood pressure drugs, hypoglycemic drugs, insulin, etc.;To observe and compare the changes of cognitive function between the control group and the study group, to detect the levels of calcium ion and orphanin fQ, and to conduct correlation analysis.To seek new theoretical basis and take corresponding treatment measures to improve the prognosis of patients with diabetic cognitive dysfunction and the quality of anesthesia surgery.

Objective: To investigate the changes of cognitive function and serum levels of calcium, inflammatory factors and orphanin fQ in diabetic patients under general anesthesia and non-general anesthesia.

Methods: the general anesthesia surgery of patients with diabetes is set to the team (group A), and to the general anesthesia surgery of diabetic patients as control group (group B), and then measured preoperative serum calcium ion concentration in patients with general anesthesia and solitary brown peptide content, intraoperative blood serum calcium ion concentration and solitary fei peptide content, and postoperative serum calcium and solitary brown peptide content. Postoperative cognitive function were evaluated in both groups.Finally, the two groups of patients were screened and the inconsistent medical records were eliminated.Observation indicators: Endothelin, C-reactive protein, nitric oxide, interleukin-6, calcium ion concentration, orphanin fq concentration, glycated hemoglobin value and blood glucose value were observed before, during and after operation.

The cognitive function of diabetic patients after surgery was observed. The cognitive function was evaluated with the cognitive function assessment scale 24 hours after surgery, respectively, and scores were obtained.

Statistical processing: Statistical Product and Service Solutions （SPSS ）21.0 statistical software was used for data analysis. Measurement data consistent with normal distribution were expressed as (mean±SD). Independent sample T-test was used for data comparison between the two groups.Repeated measurement data were compared by repeated measurement anOVA, and P < 0.05 was considered statistically significant.

Expected results: Compared with the clinical data of the control group and the study group, the cognitive function of patients in the study group was lower than that in the control group, the serum levels of orphanin fq in the analysis group were higher than those in the control group, and the levels of calcium ions in the analysis group were lower than those in the control group, and the differences were statistically significant.The results showed that when the cognitive function decreased, the content of orphanin fq increased, the content of corresponding inflammatory factors increased, and the content of calcium decreased, indicating that the change of consciousness state and cognitive function were correlated with the orphanin fQ system.

Study Type

Observational

Enrollment (Anticipated)

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 Contact

Study Locations

  • China
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • Second of Shanxi Medical University
        • Principal Investigator:
          • Zheng Guo

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

40 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Diabetic patients under general anesthesia, diabetic patients of different ages, diabetic patients of different course of disease, diabetic patients with different blood glucose levels

Description

Inclusion Criteria:

  • The study group was diagnosed as type 2 diabetes by endocrinologist;
  • Patients aged 40 or above;
  • Patients with diabetes with a course of 5-10 years, 10-15 years or more;
  • Duration of operation is 2-3h, American Society of Anesthesiologists (ASA)grade II-III;
  • The blood glucose level of diabetic patients undergoing general anesthesia should be controlled within the normal range, and the hemoglobin of patients should be controlled within the normal range.

Exclusion Criteria:

  • A definite history of central nervous system (CNS) diseases that may cause cognitive changes, such as craniocerebral trauma, craniocerebral tumor, intracranial infection, Parkinson's disease, and CNS demyelination disease;
  • Mental retardation or congenital intelligence disorder, poor compliance;
  • Patients with alcohol dependence, drug addiction and long-term use of mental and other drugs that affect cognitive function;
  • Failure of major organs (heart, lung, liver, kidney) and critically ill patients (patients with severe trauma and infection);
  • Patients with hyperthyroidism, hypothyroidism and other thyroid dysfunction and parathyroid dysfunction;
  • Patients who need blood transfusion for treatment during hospitalization or have excessive blood loss during perioperative period;
  • Patients with electrolyte disturbance;Patients with abnormal clotting function;
  • Patients whose serum levels of endothelin, C-reactive protein, nitric oxide and interleukin-6 increased beyond the normal range after surgery.

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
Experimental group
interventions:general anesthesia drugs:propofol、muscle relaxant、pain relievers(fentanbyl、sufentanil)
Other: anaesthetic
different states of consciousness
control group
interventions:intraspinal anesthesia drugs:ropivacaine、pain relievers(fentanbyl、sufentanil)
Other: anaesthetic
different states of consciousness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of the cognitive function of diabetic patients after surgery .
Time Frame: change from the baseline score at 24 hours after the treatment
The cognitive function was evaluated with the cognitive function assessment scale 24 hours after surgery, and scores were obtained.（the Montreal Cognitive Assessment, MoCA. The highest score of the test is 30 points, which is higher than or equal to 26 points is the normal level.）
change from the baseline score at 24 hours after the treatment
the Orphanin-FQ blood level
Time Frame: change from the baseline Orphanin-FQ blood level at 24 hours after the treatment
change from the baseline Orphanin-FQ blood level at 24 hours after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Hospital of Shanxi Medical University

Investigators

  • Study Chair: Guo zhen, doctor, Second Hospital of Shanxi Medical University

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 20, 2020

Primary Completion (ANTICIPATED)

December 20, 2021

Study Completion (ANTICIPATED)

December 30, 2021

Study Registration Dates

First Submitted

July 19, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (ACTUAL)

October 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 30, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hanyi20200701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The consent of the participants has not been obtained

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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