Different Anesthetic Managements of Esophageal Resection and Reconstruction

Anesthesia Clinical Trial

Official title:

The Effects of Different Anesthetic Managements on Inflammation, Oxidative Injuries, and Major Organ Complications: a Prospective Investigations on Esophageal Reconstruction and Intraoperative Shock

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02961140
• Other study ID #: 201512052RINB
• Status: Not yet recruiting
• Phase: N/A
• First received: November 6, 2016
• Last updated: November 8, 2016
• Start date: November 2016
• Est. completion date: November 2019

Study information

• Verified date: November 2016
• Source: National Taiwan University Hospital
• Contact: Ya-jung Cheng, M.D., Ph.D
• Phone: +886-2-23123456
• Email: chengyj[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

Anesthetic management and fluid therapy is crucial in esophageal resection and reconstruction, which is associated with high incidence of postoperative morbidity and mortality. This study aims to investigate the effect of goal directed fluid management on the postoperative outcome of esophageal resection and reconstruction.

Description:

Anesthetic management and fluid therapy is crucial in esophageal resection and reconstruction, which is associated with high incidence of postoperative morbidity and mortality. Excessive fluid administration may result in pulmonary complication, while extremely hypovolemia may lead to shock, circulatory dysfunction, and renal damage. Little is known about fluid status will have impact on anastomotic leakage. Goal-directed fluid therapy has shown to benefit perioperative outcome in major abdominal surgery. This study aims to investigate the effect of goal directed fluid management on the postoperative outcome of esophageal resection and reconstruction.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed as esophageal cancer

• Scheduled for minimally invasive esophageal resection and reconstruction

Exclusion Criteria:

• End-stage organ dysfunction, including heart failure, hepatic failure, renal failure

• Arrhythmia

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia
• Esophageal Neoplasms
• Esophagus Cancer
• Postoperative Complications

Intervention

Other:
• Cardiac Output Maximization
According to Frank-Starling law, the investigator will administer Voluven 6% 250 mL every 5 minute until stroke volume maximized (stabilized for 20 minutes), and maintain cardiac index and stroke volume variation during the whole operation.
• Cardiac Output Normalization
The investigator will administer intravenous fluids to keep cardiac index (CI) = 2.2, and maintain CI and stroke volume variation during the whole operation.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Ministry of Science and Technology, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative complication	Perioperative mortality, anastomotic leakage, pneumonia, respiratory failure, renal dysfunction, and surgical site infection	1 month	No
Secondary	Intraoperative hemodynamic stability	Incidence of intraoperative shock, use of vasopressor or inotropic agents	1 day	No
Secondary	Length of stay	Intensive care unit length of stay and hospital stay	1 month	No