An interventional study of Norepinephrine and Placebo in Intraoperative Hypotension, Postoperative Pulmonary Complications (PPCs) and Fluid Over-load, sponsored by Suez Canal University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Suez Canal University · Not applicable, Interventional, and Treatment
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.
885 studies on the registry are indexed under Hypotension; 195 are open to participants now.
This study's planned enrollment of 130 is above the median of 87 across 590 interventional studies indexed under Hypotension.
Browse Hypotension studies →Suez Canal University is the lead sponsor of 164 studies on the registry; 38 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive continuous norepinephrine infusion at a fixed dose of 0.03 µg/kg/min initiated immediately after induction of anesthesia and continued until skin closure within a protocolized hemodynamic management strategy.
Drug: Norepinephrine
Participants will receive an equivalent volume normal saline infusion initiated immediately after induction of anesthesia and continued until skin closure within the same protocolized hemodynamic management strategy.
Other: Placebo
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.
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)
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
Time frame: Within seven postoperative days
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.
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)
Duration of Rescue Norepinephrine Requirement
Cumulative duration of rescue open-label norepinephrine infusion for persistent hemodynamic instability measured in minutes.
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 using nvasive arterial blood pressure monitoring.
Time frame: From induction of anesthesia until skin closure (Intraoperative period)
Number of Participants Admitted to the Intensive Care Unit
Number of participants requiring admission to the intensive care unit during the postoperative period.
Time frame: Within seven postoperative days
Duration of Postoperative Hospital Stay
Total postoperative hospital stay measured in days during the first seven postoperative days
Time frame: Within seven postoperative days
Number of Participants With 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
Plan to share: No
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Norepinephrine