Norepinephrine Prevent Post-induction Hypotension in High-risk Patients

Launched by FIRST AFFILIATED HOSPITAL OF KUNMING MEDICAL UNIVERSITY · Aug 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether giving a medication called norepinephrine before and after the start of general anesthesia can help prevent low blood pressure (hypotension) in patients who are at high risk. The researchers want to see if this treatment can make surgeries safer for older adults, especially those with certain heart or blood pressure conditions.

To participate in this study, patients need to be over 65 years old or over 45 with specific heart-related problems, such as high blood pressure or diabetes. They should be scheduled for major surgery that lasts more than two hours. However, some people may not be eligible, including those with certain heart rates or blood pressure levels, recent serious health issues, or specific allergies. If someone joins, they will receive the norepinephrine infusion during their surgery, and the doctors will monitor their blood pressure closely to see how well it works. This trial aims to improve safety and outcomes for patients undergoing significant surgeries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients aged above 65 years or those above 45 years with at least one of the following preoperative cardiovascular diseases: essential hypertension, coronary artery disease, stroke, or type I/II diabetes mellitus.
• • Patients who will receive major noncardiac surgery as open or laparoscopic abdominal surgeries with an anticipated operative duration over two hours, including gastrointestinal, liver, pancreatic, bladder, and uterine/adnexal surgeries.
• Exclusion Criteria:
• • Patients who declined to participate in the present study.
• • Patients enrolled in another ongoing clinical study.
• • Patients with systolic arterial pressure (SAP) below 90 mmHg or above 160 mmHg, or heart rate (HR) over 100 beats per minute (bpm) before anesthesia induction.
• • Patients who have experienced any type of shock within 30 days before surgery.
• • Patients with circulatory instability require continuous or intermittent positive inotropic and/or vasopressors within 24 hours before surgery.
• • Patients receive continuous or intermittent intravenous antihypertensive agents within 24 hours before surgery.
• • Patients underwent coronary artery bypass grafting, coronary angiography, or coronary stenting within 180 days before surgery.
• • Patients who were diagnosed with new-onset tachyarrhythmia within 180 days before surgery, such as atrial fibrillation, atrial flutter, and premature ventricular contractions.
• • Patients with preoperative alanine aminotransferase \>80 international units and/or glomerular filtration rate \< 80 ml/min within the 180 days before surgery.
• • Patients are ineligible for intraoperative invasive radial artery blood pressure monitoring.
• • Patients with a known history of allergy to norepinephrine.
• • Patients who were planned for rapid sequence induction.
• • Patients who were scheduled for awake tracheal intubation.
• • Patients who were scheduled for double-lumen endotracheal intubation. Pregnant or lactating patients.