Postoperative Complications, Pulmonary Complication
Conditions
Keywords
Norepinephrine, Goal-directed fluid therapy, Lung ultrasound, Hepatobiliary surgery, Assiut
Brief summary
This prospective randomized controlled study aims to compare the effect of low-dose norepinephrine combined with conservative goal-directed fluid therapy versus conventional fluid therapy on postoperative pulmonary complications assessed by lung ultrasound score in patients undergoing major hepatobiliary surgery.
Detailed description
Major hepatobiliary surgery is associated with significant fluid shifts and risk of postoperative pulmonary complications. Lung ultrasound score can quantify loss of lung aeration. This study will randomize adult patients undergoing elective major hepatobiliary surgery into two groups: one receiving conventional perioperative fluid management and the other receiving low-dose norepinephrine infusion combined with conservative goal-directed fluid therapy. Lung ultrasound score will be assessed at baseline and postoperatively.
Interventions
Standard perioperative fluid administration based on maintenance requirements, fasting deficit, and third-space losses at 6-8 mL/kg/h using crystalloid solutions.
DRUGLow-Dose Norepinephrine
Continuous intravenous infusion of norepinephrine starting at 0.03-0.05 µg/kg/min, titrated according to hemodynamic parameters.
OTHERConservative Goal-Directed Fluid Therapy
Restricted third-space fluid replacement at 2 mL/kg/h guided by stroke volume variation or pulse pressure variation.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients aged 18 years or older * Scheduled for elective major hepatobiliary surgery * ASA physical status I-III * Written informed consent
Exclusion criteria
* Emergency surgery * Pre-existing pulmonary disease * Preoperative B-lines ≥3 in any lung zone * Preoperative pulmonary infection or pneumonia * Compromised heart function (ejection fraction \<50%) * Chronic kidney disease (eGFR \<30 mL/min/1.73m²) * Known allergy or contraindication to study fluids * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in lung ultrasound score | At postoperative day 1 | Mean change in total lung ultrasound score from preoperative baseline to postoperative day 1. Total score is the sum of scores from 12 lung zones (range 0 to 36, higher scores indicate greater loss of lung aeration). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung ultrasound score | At postoperative day 3 | Mean total lung ultrasound score (range 0 to 36, higher scores indicate greater loss of lung aeration). |
| Number of patients with postoperative pulmonary complications | At 28 days | Number of patients who develop postoperative pulmonary complications within 28 days after surgery. |
| Serum creatinine | At postoperative day 1 | Mean serum creatinine level in milligrams per deciliter.. |
| Urine output | At postoperative day 1 | Mean urine output in milliliters per kilogram per hour. |
Contacts
CONTACTShimaa G Maher, Resident
STUDY_CHAIRSamy A Amr, prof
Anesthesia and postsurgical ICU and pain management Department, Assiut University Hospitals
Outcome results
None listed