Comparison of Perioperative Standard Fluid Management and Goal-Directed Fluid Management
- Conditions
- Perioperative Fluid Management
- Interventions
- Other: Crystalloid solutionOther: Colloid solution
- Registration Number
- NCT04728178
- Lead Sponsor
- Istanbul University
- Brief Summary
To compare the goal-directed fluid therapy based on the data obtained from the hemodynamic monitoring system, which provides continuous CO, SV and SVV measurements through arterial pressure wave with standard fluid therapy in perioperative fluid management of patients undergoing head and neck surgery.
- Detailed Description
Following the ethics committee approval and patients consent, the study was completed with a total of ASA I-III, 60 patients over the age of 18 who will undergo head and neck surgery.After randomization, patients underwent arterial cannulation. The arterial cannulas of the study group patients were integrated into the hemodynamic monitoring system with a special transducer, and their fluid management was planned to achieve a target value of 13% or less through SVV monitoring. In the control group, fluid management was set as MAP (Mean arterial pressure) 65 mmHg and above and diuresis 0.5ml/kg/hour and above. Crystalloid infusion at 7ml/kg/hour was started in both groups. When SVV value increased to 13% and over in the study group, 250 ml of crystalloid was given in the first stage, and if it continued to be 13% and over, 250 ml of colloid bolus was given. Vasoconstrictor agent was used when SVV was below 13% and MAP was below 65 mmHg. The patients in the control group were given 250 ml of crystalloid in the first stage if the MAP was below 65 mmHg, and 250 ml of colloid bolus if the hypotensive episode continued. If hypotension persisted despite these fluid boluses, a vasoconstrictor agent was used. In addition, when the diuresis of the patients was detected at 0.5mg/kg/hr or less, 250 ml of colloid bolus was administered.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Volunteering to participate in the study
- ASA classification 1, 2 or 3
- The patients who will undergo head and neck surgery
- Being under the age of 18 or over the age of 80
- Presence of serious cardiac, renal and liver pathology ( ejection fraction< %35 and/or glomerular filtration rate< 30ml/kg/min, kreatinin>2,5mg/dl and/or abnormal liver function test)
- The patients who have heart rhythm problems such as atrial fibrillation, sinus tachycardia, ventricular extrasystoles
- The patients who have a peripheral arterial disease
- Being a morbid obese ( BMI>40 kg/m2)
- the patients who may have considered difficult airway
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description study group Crystalloid solution In the control group, fluid management was set as MAP (Mean arterial pressure) 65 mmHg and above and diuresis 0.5ml/kg/hour and above. Crystalloid infusion at 7ml/kg/hour was started. When SVV value increased to 13% and over in the study group, 250 ml of crystalloid was given in the first stage, and if it continued to be 13% and over, 250 ml of colloid bolus was given. Vasoconstrictor agent was used when SVV was below 13% and MAP was below 65 mmHg. study group Colloid solution In the control group, fluid management was set as MAP (Mean arterial pressure) 65 mmHg and above and diuresis 0.5ml/kg/hour and above. Crystalloid infusion at 7ml/kg/hour was started. When SVV value increased to 13% and over in the study group, 250 ml of crystalloid was given in the first stage, and if it continued to be 13% and over, 250 ml of colloid bolus was given. Vasoconstrictor agent was used when SVV was below 13% and MAP was below 65 mmHg. control group Crystalloid solution In the control group, fluid management was set as MAP (Mean arterial pressure) 65 mmHg and above and diuresis 0.5ml/kg/hour and above. Crystalloid infusion at 7ml/kg/hour was started. They were given 250 ml of crystalloid in the first stage if the MAP was below 65 mmHg, and 250 ml of colloid bolus if the hypotensive episode continued. If hypotension persisted despite these fluid boluses, a vasoconstrictor agent was used. In addition, when the diuresis of the patients was detected at 0.5mg/kg/hr or less, 250 ml of colloid bolus was administered. control group Colloid solution In the control group, fluid management was set as MAP (Mean arterial pressure) 65 mmHg and above and diuresis 0.5ml/kg/hour and above. Crystalloid infusion at 7ml/kg/hour was started. They were given 250 ml of crystalloid in the first stage if the MAP was below 65 mmHg, and 250 ml of colloid bolus if the hypotensive episode continued. If hypotension persisted despite these fluid boluses, a vasoconstrictor agent was used. In addition, when the diuresis of the patients was detected at 0.5mg/kg/hr or less, 250 ml of colloid bolus was administered.
- Primary Outcome Measures
Name Time Method Intraoperative fluid balance during surgery the total and additional amount of crystalloid and colloid fluid fluid given during the surgery
- Secondary Outcome Measures
Name Time Method Prolonged oxygen demand during 8 hours after surgery The need for additional oxygen application with a mask for 8 hours or more in patients who are taken into postoperative service follow-up.
Heart rate during surgery EKG
Prolonged IMV demand during 8 hours after surgery The need for artificial respiration for 8 hours or more in patients admitted to the postoperative intensive care unit.
hypoxia during surgery blood gas machine
hypercarbia during surgery blood gas machine
pulmonary infection postoperative period (up to 6 weeks) sputum culture test
Blood Pressure during surgery Arterial line and pressure transducer
hospitalisation time postoperative period (up to 6 weeks) calendar
lenght of stay in ICU postoperative period (up to 6 weeks) calendar
Trial Locations
- Locations (1)
Istanbul University, Department of Anesthesiology
🇹🇷Istanbul, Fatih, Turkey