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

Comparison of Perioperative Standard Fluid Management and Goal-Directed Fluid Management in Patients Undergoing Head and Neck Surgery: A Prospective Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04728178
Enrollment
60
Registered
2021-01-28
Start date
2017-10-01
Completion date
2019-05-01
Last updated
2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Fluid Management

Keywords

fluid therapy, prolonged oxygen demand, perioperative fluid balance

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.

Interventions

OTHERCrystalloid solution

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

OTHERColloid solution

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

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative fluid balanceduring surgerythe total and additional amount of crystalloid and colloid fluid fluid given during the surgery

Secondary

MeasureTime frameDescription
Prolonged oxygen demandduring 8 hours after surgeryThe need for additional oxygen application with a mask for 8 hours or more in patients who are taken into postoperative service follow-up.
Heart rateduring surgeryEKG
Blood Pressureduring surgeryArterial line and pressure transducer
hospitalisation timepostoperative period (up to 6 weeks)calendar
Prolonged IMV demandduring 8 hours after surgeryThe need for artificial respiration for 8 hours or more in patients admitted to the postoperative intensive care unit.
hypoxiaduring surgeryblood gas machine
hypercarbiaduring surgeryblood gas machine
pulmonary infectionpostoperative period (up to 6 weeks)sputum culture test
lenght of stay in ICUpostoperative period (up to 6 weeks)calendar

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026