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NCT02003066 Clinical Trial

Effect of Goal-directed Fluid Therapy Using Stroke Volume Variation in Patients Undergoing Free Flap Reconstruction After Head and Neck Cancer Resection

General Anesthesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02003066
Other study ID # 4-2013-0638
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 20, 2014
Est. completion date March 8, 2016

Study information
Verified date January 2019
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigators hypothesized that goal-directed fluid therapy using stroke volume variation will improve postoperative recovery in patients undergoing free flap reconstruction after head and neck cancer resection. Investigators will compare the effect of goal-directed fluid therapy using stroke volume variation on recovery in patients undergoing free flap reconstruction after head and neck cancer resection.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date March 8, 2016
Est. primary completion date March 8, 2016
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- adult patients of age over 20 years scheduled for free flap reconstruction after head and neck cancer resection

Exclusion Criteria:

- valvular heart disease

- congestive heart failure

- liver failure

- renal failure

- pregnant woman

- allergy to hydroxyethyl starch solutions

- coagulation abnormalities

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Standard fluid therapy
In Standard fluid therapy group, the administration of fluid will be guided to maintain mean blood pressure more than 65 mmHg, urine output more than 0.5 ml/kg/hr, and central venous pressure less than 14 mmHg.
• Conservative fluid therapy
In Goal directed fluid therapy group, the administration of fluid will be guided by stroke volume variation. The anesthesiologist will infuse volulyte (Fresenius Kabi, Bad Homburg, Germany) 200 ml if stroke volume variation is over 12%. If cardiac index is below 2.5 l/min/m2 and stroke volume variation is below 12%, start dobutamine.

Locations
Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Yonsei University Health System Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Length of hospital stay 1 month after surgery
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