Ignite Creation Date:
2025-12-18 @ 9:34 AM
Ignite Modification Date:
2025-12-23 @ 11:15 PM
Study NCT ID:
NCT04728178
Status:
None
Last Update Posted:
2021-01-28 00:00:00
First Post:
2021-01-20 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Perioperative Standard Fluid Management and Goal-Directed Fluid Management
Sponsor:
None
Organization:
Study Overview
Official Title:
Comparison of Perioperative Standard Fluid Management and Goal-Directed Fluid Management in Patients Undergoing Head and Neck Surgery: A Prospective Randomized Clinical Trial
Status:
None
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: