UnknownNot Applicable

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

388 participantsStarted 2024-06-01

Plain-language 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?

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 fo…

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in perioperative core body temperature in diabetic patients

Timeframe: 12 hours before surgery,during operation,12 hours after surgery

Trial details

NCT IDNCT06432270

SponsorZhujiang Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-05-01

Contact for this trial

Xinying Wang, Master

86-13539410563 597436551@qq.com

View on ClinicalTrials.gov More Diabetic Autonomic Neuropathy Type 2 trials