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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
130
Continuous norepinephrine infusion administered at a fixed dose of 0.03 µg/kg/min from induction of anesthesia until skin closure.
Equivalent 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.
Suez Canal University Hospitals
Ismailia, Ismailia Governorate, Egypt
Total intraoperative crystalloid administration
Total volume of crystalloid administered intraoperatively from induction of anesthesia until skin closure, measured in milliliters.
Time frame: From induction of anesthesia until skin closure (intraoperative period)
Postoperative Pulmonary Complications
Incidence of postoperative pulmonary complications defined according to European Perioperative Clinical Outcome (EPCO) criteria using clinical, radiological, and laboratory findings
Time frame: Within seven postoperative days
Acute Kidney Injury
Incidence of acute kidney injury defined according to KDIGO criteria based on serum creatinine changes and urine output.
Time frame: Within seven postoperative days
Lactate Levels
Arterial lactate concentration measured in mmol/L serially during the perioperative period
Time frame: After induction of anesthesia, at the end of surgery, and 24 hours postoperatively
Urine Output
Hourly intraoperative urine output measured from urinary catheter collection and expressed as total mL/kg/hour.
Time frame: From induction of anesthesia until skin closure (Intraoperative period)
Intraoperative Blood Loss
Estimated intraoperative blood loss measured in milliliters using suction canister volume after subtraction of irrigation fluids in addition to surgical field assessment.
Time frame: From surgical incision until skin closure (Intraoperative period)
Rescue Norepinephrine Requirement
Requirement for rescue open-label norepinephrine infusion for persistent hemodynamic instability including cumulative duration of infusion measured in minute
Time frame: From induction of anesthesia until skin closure (Intraoperative period)
Duration of Intraoperative Hypotension
Cumulative duration of intraoperative hypotension defined as mean arterial pressure below 65 mmHg, measured in minutes and recorded from invasive arterial blood pressure monitoring.
Time frame: From induction of anesthesia until skin closure (Intraoperative period)
Intensive Care Unit Admission
Admission to the intensive care unit during the postoperative period.
Time frame: Within seven postoperative days
Length of Hospital Stay
Total postoperative hospital stay measured in days during the first seven postoperative days
Time frame: Within seven postoperative days
Postoperative Surgical Complications
Incidence of postoperative surgical complications assessed according to Clavien-Dindo classification grade II or higher during the first seven postoperative days.
Time frame: Within seven postoperative days
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