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

NCT06432270 | Not Yet Recruiting DMC

• 1 other identifier: 2022-KY-209-02
• Study Type: observational
• Target: 388
• Locations: 0 countries
• Sites: N/A

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?

Conditions

Diabetic Autonomic Neuropathy Type 2; Perioperative Complication; Temperature Change, Body

Keywords

diabetes; general anesthesia; Cardiac autonomic dysfunction; perioperative temperature

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• time to onset of temperature drop

  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

  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

  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)

  12 hours before surgery,12 hours after surgery

Other Outcomes (3)

• Age

  the preoperative visit period

• Height

  the preoperative visit period

• BMI

  the preoperative visit period

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

MeSH Terms

Conditions

Body Temperature Changes; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Zhujiang Hospital of Southern Medical University

  Southern Medical University, China

  STUDY CHAIR

Central Study Contacts

Xinying Wang, Master

CONTACT

86-13539410563; 597436551@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 29, 2024
• Study Start: June 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-05