Cognitive DysfunctionNCT04576767
Changes of Cognitive Function and Orphanin FQ in Diabetic Patients Under General Anesthesia.
An observational study of Cognitive Dysfunction, run by Second Hospital of Shanxi Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction
- What is being tested?
- anaesthetic
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2020to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second of Shanxi Medical University
Taiyuan, Shanxi, 030001
Zheng Guo, 13753171979, 13753171979@163.com
Zheng Guo
About this study
Official title: 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.
Read the 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.
- Conditions
- Cognitive Dysfunction
- Being tested
- anaesthetic
- Keywords
- The orphanin system, calcium ion, inflammatory factor
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anaestheticOther
different states of consciousness
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | interventions:general anesthesia drugs:propofol、muscle relaxant、pain relievers(fentanbyl、sufentanil) Receives: Other: anaesthetic | |
| control group | interventions:intraspinal anesthesia drugs:ropivacaine、pain relievers(fentanbyl、sufentanil) Receives: Other: anaesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.）
Measured: change from the baseline score at 24 hours after the treatment
the Orphanin-FQ blood level
Measured: change from the baseline Orphanin-FQ blood level at 24 hours after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start20 Oct 2020
- Primary completion20 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Guo, Second Hospital of Shanxi Medical University
- Investigators
- Guo zhen, doctor, Study chair, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576767
- Sponsor's protocol ID
- hanyi20200701
- Status last verified
- Oct 2021
- First submitted
- 19 Jul 2020
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The consent of the participants has not been obtained
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Cognitive Function and Serum Levels of Calcium, Inflammatory Factors and Orphanin fQ in Diabetic Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT04576767
- Acronym / sponsor ID
- hanyi20200701
- Conditions
- Cognitive Dysfunction
- Keywords
- The orphanin system, calcium ion, inflammatory factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 6 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Other: anaestheticinterventions:general anesthesia drugs:propofol、muscle relaxant、pain relievers(fentanbyl、sufentanil) |
| control group | – | Other: anaestheticinterventions:intraspinal anesthesia drugs:ropivacaine、pain relievers(fentanbyl、sufentanil) |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anaestheticdifferent states of consciousness | Other | Experimental group, control group |
Primary outcome
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.）
the Orphanin-FQ blood level
Time frame: change from the baseline Orphanin-FQ blood level at 24 hours after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Individual participant dataSharing planned: Undecided. The consent of the participants has not been obtained
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guo zhen, doctor study chair
Second Hospital of Shanxi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Dysfunction, run by Second Hospital of Shanxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yi a han, doctor (13753171979 ext. 086, 13753171979@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of the cognitive function of diabetic patients after surgery . (time frame: change from the baseline score at 24 hours after the treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.