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

NCT04576767 | Unknown DMC

• 1 other identifier: hanyi20200701
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Dysfunction

Keywords

The orphanin system; calcium ion; inflammatory factor

Outcome Measures

Primary Outcomes (2)

• Score of the cognitive function of diabetic patients after surgery .

  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

  change from the baseline Orphanin-FQ blood level at 24 hours after the treatment

Study Arms (2)

Experimental group

interventions:general anesthesia drugs:propofol、muscle relaxant、pain relievers(fentanbyl、sufentanil)

Other: anaesthetic

control group

interventions:intraspinal anesthesia drugs:ropivacaine、pain relievers(fentanbyl、sufentanil)

Other: anaesthetic

Interventions

anaesthetic OTHER

different states of consciousness

Experimental group; control group

Eligibility Criteria

• Age: 40 Years - 90 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Hospital of Shanxi Medical University: lead

Study Sites (1)

Second of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Anesthetics

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Guo zhen, doctor

  Second Hospital of Shanxi Medical University

  STUDY CHAIR

Central Study Contacts

yi a han, doctor

CONTACT

13753171979; 13753171979@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigation

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: October 6, 2020
• Study Start: October 20, 2020
• Primary Completion: December 20, 2021
• Study Completion: December 30, 2021
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

CN (1)