Clinical trial

Continuous Norepinephrine Infusion Before General Anesthesia to Prevent Post-induction Hypotension in High-risk Patients Undergoing Major Noncardiac Surgery

Name

2023-L-126

Description

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.

Trial arms

Trial start

2023-10-01

Estimated PCD

2024-04-01

Trial end

2024-10-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

Norepinephrine Hydrochloride

Both arms of patients will receive standard anesthesia and surgical management. Radial artery cannulation and invasive blood pressure monitoring will be perform. Norepinephrine will be pumped at a rate of 10 ml/h for 5 minutes before anesthesia induction to skin incision.

Arms:

Norepinephrine

Placebo

Normal saline will be pumped at a rate of 10 ml/h for 5 minutes before anesthesia induction to skin incision.

Arms:

Placebo

Size

180

Primary endpoint

Incidence of post-induction hypotension

From induction of general anesthesia to skin incision (up to one hour from induction of general anesthesia)

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 180, 'type': 'ESTIMATED'}}

Updated at

2023-09-08

1 organization

1 product

1 drug

3 indications

Organization

First Affiliated Hospital of Kunming Medical University

Product

Indication

Indication

Indication

Drug