The effect of noradrenaline infusion versus standard blood pressure management on perioperative HYPotension in NOncaRdiac surgery.

Phase 1

• Conditions: hypotension in non-cardiac surgery; MedDRA version: 21.0Level: LLTClassification code: 10056679Term: Intraoperative hypotension Class: 10022117; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-508255-39-00
• Lead Sponsor: niwersytet Jagiellonski Collegium Medicum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-26
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

=45years old, Elective or accelerated* for noncardiac surgery expected to last = 1 hour and requiring general, neuraxial, or combined general & neuraxial anaesthesia, Expected to require at least overnight hospital stay, Written informed consent to participate in the HYP-NOR Trial provided, American Society of Anesthesiologists (ASA) physical status class II or higher.

Exclusion Criteria

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, Receiving irreversible nonselective monoamine oxidase inhibitors (e.g. tranylcypromine, phenelzine) within 2 weeks preceding study enrolment, 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, Persistent difference in recorded SBP between right and left upper limb >10 mm Hg, Persistent atrial fibrillation, End-stage heart failure, Known severe liver disease, Emergency and urgent surgery defined as performed within 24 hours of sudden illness/unplanned admission to hospital, Have previously participated in the trial, Pregnant or breastfeeding women, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified