Clinical trial NCT06028256: Norepinephrine Prevent Post-induction Hypotension in High-risk Patients
Official title: Continuous Norepinephrine Infusion Before General Anesthesia to Prevent Post-induction Hypotension in High-risk Patients Undergoing Major Noncardiac Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Anesthesia
Blood Pressure
Norepinephrine
Keywords: intraoperative hypotension
arterial pressure
general surgery
general anesthesia
noncardiac surgery
Lead sponsor: First Affiliated Hospital of Kunming Medical University
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 180
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators aimed to investigate the effects of continuous infusion of norepinephrine before and after general anesthesia induction on the occurrence of post-induction hypotension.

Detailed description: Intraoperative hypotension is common after general anesthesia induction and is associated with adverse postoperative events. Norepinephrine is one of the most applied vasopressors in clinical to treat intraoperative hypotension. Due to the absence of effective measures for predicting intraoperative hypotension, infusing norepinephrine before and during anesthesia induction may reduce intraoperative hypotension. There is currently a lack of research regarding whether continuous norepinephrine infusion before and during the induction of general anesthesia can mitigate or prevent post-induction hypotension. The investigators aim to investigate the effects of continuous infusion of norepinephrine before and after general anesthesia induction on the occurrence of post-induction hypotension.

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.

Primary outcomes:
measure: Incidence of post-induction hypotension
timeFrame: From induction of general anesthesia to skin incision (up to one hour from induction of general anesthesia)
Secondary outcomes:
measure: Incidence of the following abnormal vital signs
timeFrame: From induction of general anesthesia to skin incision (up to one hours from induction of general anesthesia)
measure: Incidence of the following abnormal vital signs
timeFrame: From surgical incision to the end of surgery (up to six hours from surgical incision)
measure: Incidence of the following abnormal vital signs
timeFrame: from the end of surgery until leaving the post-anesthesia care unit (up to four hours from the end of surgery)
measure: Postoperative major adverse cardiac events
timeFrame: Within 30 days after surgery
Other outcomes:
Locations:
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