Effect of Diabetes Mellitus on Cardiac Autonomic Function in Surgical Patients Undergoing General Anesthesia

A Prospective Cohort Study of the Effect of Diabetes Mellitus on Cardiac Autonomic Function in Surgical Patients Undergoing General Anesthesia

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Temperature Change, Body; Perioperative Complication; Diabetic Autonomic Neuropathy Type 2

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 increasing.In 2021, there are 537 million people with diabetes globally, and there are about 141 million in China, which is an increase of about 21.55% compared with 2019 . Perioperative hypothermia is a clinical phenomenon in which a patient's core body temperature is below 36°C for non-medical purposes during the perioperative period, with an incidence of about 7-90%, which can lead to a variety of adverse outcomes.In 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 Type: Observational
• Enrollment (Estimated): 388

Contacts and Locations

• Study Contact: Name: Xinying Wang, Master; Phone Number: 86-13539410563; Email: 597436551@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This study is expected to collect patients who are hospitalized in Zhujiang Hospital of Southern Medical University and are proposed to undergo surgery

Description

Inclusion Criteria:

• 18 years old ≤ age ≤ 80 years old, gender is not limited;
• BMI index of 18-35 kg/m2 (including 18 kg/m2 and 35 kg/m2 );
• Diagnosed with diabetes mellitus;
• ASA Ⅰ - Ⅱ;
• Elective laparoscopic abdominal surgery under general anesthesia;
• Operating time >2 hours and <6 hours;
• Voluntary participation and signing of an informed consent form;
• Ability to be followed up in a timely manner.

Exclusion Criteria:

• Abnormally elevated preoperative inflammatory indicators;
• Core body temperature ≥37.5 degrees Celsius;
• Patients with previous clear central nervous system disease, history of psychiatric disorders, or epilepsy;
• Patients with verbal communication or hearing or visual impairment, who were unable to communicate well and had poor compliance;
• Intraoperative use of vasodilator (uradil, sodium nitroprusside, nitroglycerin);
• Any high-risk subjects with complete atrioventricular block or complete atrioventricular conduction tissue without implanted pacemakers, multiple premature ventricular beats, single premature ventricular beats (heart rate <45 beats/min), heart failure in NYHA (New York Heart Association) class III or higher;
• Subjects with any other clinically significant 12-lead electrocardiogram (ECG) or echocardiogram abnormality at the time of screening, ejection fraction (EF) <40%, or any other significant abnormality in the opinion of the investigator;
• Subjects deemed by the investigator to be unfit for this clinical trial for any other reason (anesthesia assessment unfit for surgery or preanesthetic hypertension).

Withdrawal Criteria:

• Serious adverse events, abnormal laboratory tests, or other conditions that indicate no further benefit or increased risk to the subject's safety from continued participation in the study;
• Incomplete recording of critical data (temperature or heart rate variability);
• Unstable condition requiring further admission to the intensive care unit;
• Intraoperative use of dexmedetomidine; 5. Perioperative nerve block.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
diabetic group; Patients with a diagnosis of diabetes mellitus who are about to undergo general anesthesia who are expected to undergo laparoscopic surgery
Non-diabetic group; Nondiabetic patients anticipating laparoscopic surgery who are about to undergo general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in perioperative core body temperature in diabetic patients	The study was conducted by using a perioperative core body temperature monitoring system to continuously monitor and record core body temperature data for 12 hours preoperatively - intraoperatively - 12 hours postoperatively, and then calculating the mean core body temperature per minute at 12 hours preoperatively, intraoperatively, and 12 hours postoperatively, respectively, to compare whether diabetic patients had lower mean core body temperature per minute intraoperatively than non-diabetic patients, and whether diabetic patients had a decrease in intraoperative body temperature compared to 12 hours preoperatively and 12 hours postoperatively. Mean intraoperative core body temperature per minute (°C/min) = Mean intraoperative core body temperature/operating time.	12 hours before surgery,during operation,12 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to onset of temperature drop	observing the time period during which diabetic and non-diabetic patients began to drop below the mean temperature at 12 hours preoperatively and comparing how early or late the temperature began to drop in both groups	Baseline and 12 hours before surgery,0-30 minutes after induction ,30-60 minutes after induction,60-90 minutes after induction,90-120 minutes after induction,120-150 minutes after induction,150-180 minutes after induction,12 hours after surgery
time to temperature drop to nadir	Observing the period of time during which diabetic and non-diabetic patients experienced a drop in temperature to nadir, and comparing how fast or slow the temperature dropped to the lowest point	Baseline and 12 hours before surgery,0-30 minutes after induction ,30-60 minutes after induction,60-90 minutes after induction,90-120 minutes after induction,120-150 minutes after induction,150-180 minutes after induction,12 hours after surgery
The magnitude of body temperature decline	Comparing whether the average core body temperature of diabetic patients was lower than that of non-diabetic patients at each time period after induction.	Baseline and 12 hours before surgery,0-30 minutes after induction ,30-60 minutes after induction,60-90 minutes after induction,90-120 minutes after induction,120-150 minutes after induction,150-180 minutes after induction,12 hours after surgery
Changes in heart rate variability (HRV)	using 24-hour Holter ECG to collect HRV data from 12 hours before surgery to induction (first administration of medication), and from the time the patients left the recovery room to 12 hours after surgery, and observing the changes in HRV data of the patients of the two groups in the two time periods	12 hours before surgery,12 hours after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age of the participants(years)	the preoperative visit period
Height	Height of the participants(meters)	the preoperative visit period
BMI	BMI of the participants(kg/m2)	the preoperative visit period

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Investigators: Study Chair: Zhujiang Hospital of Southern Medical University, Southern Medical University, China

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: diabetes; general anesthesia; Cardiac autonomic dysfunction; perioperative temperature
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetes Mellitus; Diabetic Neuropathies; Body Temperature Changes
• Other Study ID Numbers: 2022-KY-209-02

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