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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Active Comparator | 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 | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crystalloid solution | Other | Crystalloid solution is a true solution and is able to pass through a semipermeable membrane. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative fluid balance | the total and additional amount of crystalloid and colloid fluid fluid given during the surgery | during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Prolonged IMV demand | The need for artificial respiration for 8 hours or more in patients admitted to the postoperative intensive care unit. | during 8 hours after surgery |
| Prolonged oxygen demand |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Demet Altun Bingol, Assoc. Prof. | Istanbul University | Principal Investigator |
| Nuray Turkut, MD | Istanbul University | Principal Investigator |
| Cansu Uzuntürk, Resident | Istanbul University | Principal Investigator |
| Emre Çamcı, Prof. | Istanbul University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University, Department of Anesthesiology | Istanbul | Fatih | 34093 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23965199 | Background | Davies SJ, Minhas S, Wilson RJ, Yates D, Howell SJ. Comparison of stroke volume and fluid responsiveness measurements in commonly used technologies for goal-directed therapy. J Clin Anesth. 2013 Sep;25(6):466-74. doi: 10.1016/j.jclinane.2013.04.010. Epub 2013 Aug 17. | |
| 26665136 | Background | Funk D, Bohn J, Mutch W, Hayakawa T, Buchel EW. Goal-directed fluid therapy for microvascular free flap reconstruction following mastectomy: A pilot study. Plast Surg (Oakv). 2015 Winter;23(4):231-4. doi: 10.4172/plastic-surgery.1000937. |
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| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| ID | Term |
|---|---|
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Colloid solution | Other | Colloid solution is a heterogeneous mixture whose particle size is intermediate between those of a solution and a suspension. |
|
The need for additional oxygen application with a mask for 8 hours or more in patients who are taken into postoperative service follow-up.
| during 8 hours after surgery |
| Heart rate | EKG | during surgery |
| Blood Pressure | Arterial line and pressure transducer | during surgery |
| hospitalisation time | calendar | postoperative period (up to 6 weeks) |
| lenght of stay in ICU | calendar | postoperative period (up to 6 weeks) |
| hypoxia | blood gas machine | during surgery |
| hypercarbia | blood gas machine | during surgery |
| pulmonary infection | sputum culture test | postoperative period (up to 6 weeks) |