Different Anesthetic Managements of Esophageal Resection and Reconstruction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Anesthesia, Esophagus Cancer, Postoperative Complications

Intervention / Treatment
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* Other: Cardiac Output Maximization
* Other: Cardiac Output Normalization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac Output Maximization<br>maximize stroke volume, and maintain cardiac index and stroke volume variation during the whole operation | Other: Cardiac Output Maximization<br>* 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.<br>|
| Active Comparator: Cardiac Output Normalization<br>keep cardiac index (CI) ≥ 2.2, and maintain CI and stroke volume variation during the whole operation | Other: Cardiac Output Normalization<br>* The investigator will administer intravenous fluids to keep cardiac index (CI) ≥ 2.2, and maintain CI and stroke volume variation during the whole operation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative complication | Perioperative mortality, anastomotic leakage, pneumonia, respiratory failure, renal dysfunction, and surgical site infection | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative hemodynamic stability | Incidence of intraoperative shock, use of vasopressor or inotropic agents | 1 day | 
| Length of stay | Intensive care unit length of stay and hospital stay | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Outcome