Comparison of Perioperative Standard Fluid Management and Goal-Directed Fluid Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-05-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Perioperative Fluid Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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study group

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.

Group Type ACTIVE_COMPARATOR

Crystalloid solution

Intervention Type OTHER

Crystalloid solution is a true solution and is able to pass through a semipermeable membrane.

Colloid solution

Intervention Type OTHER

Colloid solution is a heterogeneous mixture whose particle size is intermediate between those of a solution and a suspension.

control group

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.

Group Type PLACEBO_COMPARATOR

Crystalloid solution

Intervention Type OTHER

Crystalloid solution is a true solution and is able to pass through a semipermeable membrane.

Colloid solution

Intervention Type OTHER

Colloid solution is a heterogeneous mixture whose particle size is intermediate between those of a solution and a suspension.

Interventions

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Crystalloid solution

Crystalloid solution is a true solution and is able to pass through a semipermeable membrane.

Intervention Type OTHER

Colloid solution

Colloid solution is a heterogeneous mixture whose particle size is intermediate between those of a solution and a suspension.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Volunteering to participate in the study
2. ASA classification 1, 2 or 3
3. The patients who will undergo head and neck surgery

Exclusion Criteria

1. Being under the age of 18 or over the age of 80
2. 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)
3. The patients who have heart rhythm problems such as atrial fibrillation, sinus tachycardia, ventricular extrasystoles
4. The patients who have a peripheral arterial disease
5. Being a morbid obese ( BMI\>40 kg/m2)
6. the patients who may have considered difficult airway

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No