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

Launched by ZHUJIANG HOSPITAL · May 22, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to understand how diabetes affects heart and body temperature control in patients who are having surgery while under general anesthesia. Researchers want to find out if people with diabetes are more likely to get too cold during surgery and how their heart rate changes in this situation. This is important because diabetes can interfere with the body’s ability to manage temperature, which might lead to complications during surgery.

To participate in this study, you need to be between 18 and 80 years old, have a body mass index (BMI) between 18 and 35, and have been diagnosed with diabetes. Additionally, you must be scheduled for elective abdominal surgery that will last between 2 and 6 hours. If you join the trial, you will be monitored closely during your surgery to assess your heart rate and body temperature. It's worth noting that there are some health conditions that could exclude you from participating, such as certain heart problems or recent central nervous system issues. Overall, this study aims to improve understanding of how diabetes impacts surgical experiences, which could lead to better care for diabetic patients in the future.

Gender

ALL

Eligibility criteria

• 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.