PRO STRESS Trial: Proactive Low-Dose Norepinephrine to Reduce Intraoperative Fluid Administration in Patients at High-Risk for Postoperative Pulmonary Complications Undergoing Laparoscopic Abdominal Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuez Canal University

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

Qualifiers

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

Treatments tested in this trial

  • Norepinephrine
  • Placebo

Treatment groups

130 Participants
are divided into 2 treatment groups

Sponsors and collaborators