About this trial
Intraoperative hypotension is commonly treated with fluid administration; however, excessive fluid therapy may contribute to postoperative pulmonary complications. This randomized double-blind controlled trial evaluates whether proactive administration of fixed low-dose norepinephrine reduces intraoperative crystalloid administration while maintaining hemodynamic stability in high-risk patients undergoing laparoscopic abdominal surgery. One hundred and thirty patients will be randomized to receive either norepinephrine infusion (0.03 µg/kg/min) or placebo from induction until skin closure within a protocolized hemodynamic strategy guided by mean arterial pressure and pulse pressure variation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 18 years or older.
American Society of Anesthesiologists (ASA) physical status I-III.
Scheduled for elective laparoscopic major abdominal surgery under general anesthesia with an expected duration greater than 2 hours.
Patients with ARISCAT score ≥ 45 indicating high risk for postoperative pulmonary complications.
Disqualifiers
Known hypersensitivity to norepinephrine.
Severe left ventricular dysfunction with ejection fraction < 35%.
Significant cardiac arrhythmia.
Uncontrolled hypertension defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg.
Trial design
Parallel
Treatments tested in this trial
Norepinephrine
DrugContinuous norepinephrine infusion administered at a fixed dose of 0.03 µg/kg/min from induction of anesthesia until skin closure.
Placebo
Other interventionEquivalent volume normal saline infusion administered from induction of anesthesia until skin closure at the same infusion rate as the active intervention to maintain blinding within a protocolized hemodynamic management strategy.
Treatment groups
Trial outcomes
Primary outcomes
Total intraoperative crystalloid administration
Total volume of crystalloid administered intraoperatively from induction of anesthesia until skin closure, measured in milliliters.
Secondary outcomes
Number of Participants with Postoperative Pulmonary Complications
Incidence of postoperative pulmonary complications defined according to European Perioperative Clinical Outcome (EPCO) criteria using clinical, radiological, and laboratory findings
Number of Participants With Acute Kidney Injury
Incidence of acute kidney injury defined according to KDIGO criteria based on serum creatinine changes and urine output.
Lactate Levels
Arterial lactate concentration measured in mmol/L serially during the perioperative period
Urine Output
Hourly intraoperative urine output measured from urinary catheter collection and expressed as total mL/kg/hour.
Sponsors and contacts
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