Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432270
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-07
Brief Title:
Effect of Diabetes Mellitus on Cardiac Autonomic Function in Surgical Patients Undergoing General Anesthesia
Sponsor:
Zhujiang Hospital
Organization:
Zhujiang Hospital
Study Overview
Official Title:
A Prospective Cohort Study of the Effect of Diabetes Mellitus on Cardiac Autonomic Function in Surgical Patients Undergoing General Anesthesia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Because autonomic neuropathy affects the constriction of thermoregulatory blood vessels it is more difficult for diabetic patients to maintain their own body temperature in cold environments than normal people and therefore it is more difficult for diabetic patients to maintain a relatively constant body temperature regardless of the temperature of the environment than normal people So are diabetic patients under general anesthesia more susceptible to intraoperative hypothermia How does heart rate variability change in diabetic patients under general anesthesia If diabetic patients are more susceptible to intraoperative hypothermia under general anesthesia is this related to their cardiac autonomic dysfunction
Detailed Description:
According to the latest version of data released by the International Diabetes Federation IDF in 2021 it can be seen that the number of people with diabetes globally or in China is high and the percentage is increasingIn 2021 there are 537 million people with diabetes globally and there are about 141 million in China which is an increase of about 2155 compared with 2019 Perioperative hypothermia is a clinical phenomenon in which a patients core body temperature is below 36C for non-medical purposes during the perioperative period with an incidence of about 7-90 which can lead to a variety of adverse outcomesIn hot environments sweating and vasodilation are severely compromised in diabetic patients due to autonomic neuropathy which prevents the body from transferring heat from the inside of the body to the skin through vasodilation increased blood flow and sweating Similarly because autonomic neuropathy affects the constriction of thermoregulatory blood vessels it is more difficult for diabetic patients to maintain their own body temperature in cold environments than normal people and therefore it is more difficult for diabetic patients to maintain a relatively constant body temperature regardless of the temperature of the environment than normal people On the other hand general anesthesia and external environmental factors in the operating room increase the incidence of intraoperative hypothermia and theoretically diabetic patients are more prone to dramatic fluctuations in their own body temperature during surgery making it difficult for them to adapt to changes in the external environment Due to the complex pathophysiological mechanism of diabetes which affects multiple systems throughout the body there are currently more than 100 complications of diabetes of which autonomic neuropathy has the most serious impact on diabetic patients Cardiac autonomic neuropathy is one of the most common and serious complications of diabetic autonomic neuropathy with a prevalence of 63 And heart rate variability is one of the most common tests for diabetic cardiac autonomic dysfunction So are diabetic patients under general anesthesia more susceptible to intraoperative hypothermia How does heart rate variability change in diabetic patients under general anesthesia If diabetic patients are more susceptible to intraoperative hypothermia under general anesthesia is this related to their cardiac autonomic dysfunction However there are still no studies and little attention has been paid to it
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None