Fluid Over-load, Intraoperative Hypotension, Postoperative Pulmonary Complications (PPCs)
Conditions
Keywords
Norepinephrine, Fluid Therapy, Pulmonary Complications, Abdominal Surgery, Vasopressor
Brief summary
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.
Interventions
DRUGNorepinephrine
Continuous norepinephrine infusion administered at a fixed dose of 0.03 µg/kg/min from induction of anesthesia until skin closure.
OTHERPlacebo
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.
Sponsors
Suez Canal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * End-stage renal disease. * Requirement for vasopressor support before induction of anesthesia. * Emergency surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total intraoperative crystalloid administration | From induction of anesthesia until skin closure (intraoperative period) | Total volume of crystalloid administered intraoperatively from induction of anesthesia until skin closure, measured in milliliters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Postoperative Pulmonary Complications | Within seven postoperative days | 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 | Within seven postoperative days | Incidence of acute kidney injury defined according to KDIGO criteria based on serum creatinine changes and urine output. |
| Lactate Levels | After induction of anesthesia, at the end of surgery, and 24 hours postoperatively | Arterial lactate concentration measured in mmol/L serially during the perioperative period |
| Urine Output | From induction of anesthesia until skin closure (Intraoperative period) | Hourly intraoperative urine output measured from urinary catheter collection and expressed as total mL/kg/hour. |
| Intraoperative Blood Loss | From surgical incision until skin closure (Intraoperative period) | Estimated intraoperative blood loss measured in milliliters using suction canister volume after subtraction of irrigation fluids in addition to surgical field assessment. |
| Duration of Rescue Norepinephrine Requirement | From induction of anesthesia until skin closure (Intraoperative period) | Cumulative duration of rescue open-label norepinephrine infusion for persistent hemodynamic instability measured in minutes. |
| Duration of Intraoperative Hypotension | From induction of anesthesia until skin closure (Intraoperative period) | Cumulative duration of intraoperative hypotension defined as mean arterial pressure below 65 mmHg, measured in minutes using nvasive arterial blood pressure monitoring. |
| Number of Participants Admitted to the Intensive Care Unit | Within seven postoperative days | Number of participants requiring admission to the intensive care unit during the postoperative period. |
| Duration of Postoperative Hospital Stay | Within seven postoperative days | Total postoperative hospital stay measured in days during the first seven postoperative days |
| Number of Participants With Postoperative Surgical Complications | Within seven postoperative days | Incidence of postoperative surgical complications assessed according to Clavien-Dindo classification grade II or higher during the first seven postoperative days. |
Countries
Egypt
Contacts
CONTACTMohammad Elhossieny Salama, MD
CONTACTMahmoud Hosny Ahmed, MD
Outcome results
None listed