Noradrenaline Versus Standard Blood Pressure Management for Perioperative Hypotension in Non-cardiac Surgery
The Effect of Noradrenaline Infusion Versus Standard Blood Pressure Management on Perioperative HYPotension in NOn-caRdiac Surgery HYP-NOR Trial
Jagiellonian University
750 participants
Jun 25, 2025
INTERVENTIONAL
Conditions
Summary
The effect of noradrenaline infusion versus standard blood pressure management on perioperative HYPotension in NOn-caRdiac surgery. The study aims to determine whether perioperative noradrenaline infusion is superior to standard blood pressure management for the occurrence of perioperative hypotension.
Eligibility
Inclusion Criteria5
- ≥45 years old
- Elective or accelerated* non-cardiac surgery expected to last ≥1 hour and requiring general, neuraxial, or combined general with neuraxial anesthesia
- Expected to stay overnight in the hospital after surgery
- Written informed consent to participate in the HYP-NOR Trial provided
- American Society of Anesthesiologists (ASA) physical status class II or higher.
Exclusion Criteria18
- Newly diagnosed, untreated, or uncontrolled hypertension -in two measurements on the day before surgery Systolic Blood Pressure (SBP) ≥180 mm Hg or Diastolic Blood Pressure (DBP) ≥110 mm Hg
- Persistent difference in recorded SBP between right and left upper limb >10 mm Hg
- Persistent atrial fibrillation
- Have a documented history of dementia
- Have language, vision, or hearing impairments that may compromise cognitive assessments
- Have a condition that precludes routine blood pressure management such as surgeon request for relative hypotension
- Receiving irreversible nonselective monoamine oxidase inhibitors (e.g. tranylcypromine, phenelzine) within 2 weeks preceding study enrolment
- The use of tricyclic antidepressants
- Have Prinzmetal angina
- Have contraindications to noradrenaline per clinician judgement
- Noradrenaline infusion started before surgery or plan to use continuous noradrenaline infusion throughout the procedure
- Treating physician (surgeon/anaesthetist) decides on the necessity of extended continuous hemodynamic monitoring during or after surgery
- Severe kidney disease (MDRD creatinine clearance <15 mL/min/1.73m2) or renal replacement therapy
- End-stage heart failure: defined as NYHA Class IV - severe limitations in daily activity. Patients experience symptoms even while at rest. Mostly bedbound patients.
- Known severe liver disease: defined as the presence of liver cirrhosis or any of the symptoms of severe liver dysfunction: portal hypertension (esophageal varices, ascites), hepatocellular insufficiency (e.g., jaundice, hepatic encephalopathy) and coagulopathy (prolonged INR/APTT associated with known liver dysfunction).
- Emergency and urgent surgery defined as performed within 24 hours of sudden illness/unplanned admission to hospital
- Have previously participated in the trial: patient already took a part in the HYP-NOR trial in the past
- Pregnant or breastfeeding women.
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Interventions
A single concentration of noradrenaline (10 μg/ml) will be initiated 15-60 seconds prior to the induction of anaesthesia, then titrated and maintained until 4 hours after surgery to meet pre-specified mean arterial pressure (MAP) targets. The drug infusion will be started at a dose of 0.01 μg/kg/min and will be titrated to a maximum of 0.1 μg/kg/min. Anaesthesiologists will be advised to use the lowest possible dose of noradrenaline. Avoidance of MAP decreases of \>20% from baseline values or \<60-70 mm Hg will be required in both groups. Individual baseline MAP value will be defined as resting blood pressure obtained in at least two measurements at the surgery ward on the day before surgery. Noradrenaline will be administered peripherally in all patients who do not have a central venous catheter in place.
Patients in the control group will receive standard blood pressure management reactive to blood pressure values. In the light of the current ESA/ESC 2022 guidelines, all patients in the control group will be treated to avoid MAP \<60-70 mm Hg. Ephedrine boluses (5 mg each, up to 25 mg total intravenous dose) will be recommended as a first-line hypotension treatment. Subsequent treatment will involve administering peripheral noradrenaline. Notwithstanding, there is a variation in clinical practice regarding the choice and timing of vasopressors and fluids to be administered during and after surgery, therefore, hypotension treatment will not be further protocolized to increase the feasibility and generalizability of the trial.
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06885268