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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Yonsei University
Information provided by (Responsible Party):
Yonsei University Identifier:
First received: November 18, 2013
Last updated: November 27, 2015
Last verified: November 2015
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.

Condition Intervention
General Anesthesia
Procedure: Standard fluid therapy
Procedure: Conservative fluid therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Length of hospital stay [ Time Frame: 1 month after surgery ]

Estimated Enrollment: 62
Study Start Date: November 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard 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.
Active Comparator: Conservative Procedure: 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.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02003066

Contact: Bon-Nyeo Koo, MD 82-2-2228-2420

Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Bon-Nyeo Koo, MD    82-2-2228-2420   
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Yonsei University Identifier: NCT02003066     History of Changes
Other Study ID Numbers: 4-2013-0638
Study First Received: November 18, 2013
Last Updated: November 27, 2015

Keywords provided by Yonsei University:
Fluid Therapy
Head and Neck Neoplasms
Surgical Flaps processed this record on May 25, 2017