Ultrasound Lung Evaluation of Different Fluid Management Protocols in Patients Undergoing Laparoscopic Hysterectomy.
| Registry | NCT03429751 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, diagnostic |
| Enrollment | 48 (Actual) |
| Sponsor | Alaa Mazy (Other) |
| Conditions | Fluid Overload |
| Interventions | 30 ml/Kg/h crystalloid, 10 ml/Kg/h crystalloid (Drug) |
| Dates | start 2016-07-10, primary completion 2017-07-10, completion 2017-09-01, first posted 2018-02-12, last updated 2018-02-12 |
| Locations | 1 site in Egypt |
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Bedside lung ultrasound can detect pulmonary congestion by detecting the appearance of B-lines. Pulmonary edema may occur even without cardiomyopathy or heart failure, especially after excessive fluid administration. B-lines have been acknowledged as sonographic signs of pulmonary interstitial and alveolar edema in critical and emergency care. Limited scientific evidence on optimal intraoperative fluid management has resulted in large variations of administered fluid regimens in daily practice. The restricted perioperative intravenous fluid regimen reduces complications after elective surgeries, however other studies had shown that intraoperative liberal fluid administration improves postoperative organ functions and recovery and shortens hospital stay after elective surgeries.
A review of patients undergoing major abdominal surgery, excluding high-risk patients, compared liberal and restrictive fluid regimens; concluded that it is difficult to define 'liberal' or 'restrictive' protocols in clinical practice. patients undergoing moderate-risk surgery seem to benefit from the more liberal fluid administration, while patients undergoing high-risk or major surgery seem to benefit from restrictive or conservative strategies. Lung ultrasound used for comparison between liberal and restrictive fluid therapy in laparoscopic hysterectomy patients by detecting the B-lines intraoperatively or immediately postoperatively. The aim is to evaluate the lung ultrasound as a guide for intraoperative fluid management, being an index for increased extravascular lung water (ECLW). This operation is a moderately complex procedure that implies the Trendelenburg position. This position - in addition to liberal fluids - will increase venous return and increase the challenge on the cardiac muscle under anesthesia in these patients.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Liberal fluid group | Experimental | Drug: 30 ml/Kg/h crystalloid | received 30 ml/Kg/h crystalloid for maximum 3 hours. |
| Restrictive fluid group | Active comparator | Drug: 10 ml/Kg/h crystalloid | received 10 ml /Kg/h crystalloids for maximum 3 hours. |
Sex: Female, ages: 18 Years to 50 Years
Inclusion Criteria: * Female patients scheduled for an elective laparoscopic hysterectomy. * American society of anesthesiologists status I-II. Exclusion Criteria: * Patient refusal. * Severe cardiac insufficiency (New York Heart Association IV, myocardial infarction 3 months). * Valvular heart diseases. * Renal insufficiency (GFR<60 ml/kg/1.73m2). * Hepatic insufficiency (Albumin less than 3). * Patient with previous or current history of pulmonary disease. * History of allergy to anesthetic drugs. * Obese patients (BMI>30).
| Facility | City | Country | Status |
|---|---|---|---|
| Oncology Center Mansoura University. | Al Mansurah, Dakahlia Governorate | Egypt |