The Effects on Major Organ Complications on Esophagectomy of New Anesthetic ERAS Strategy: a Prospective Investigation

Not Applicable

• Conditions: Esophageal Cancer; Anesthesia; Complication, Postoperative
• Interventions: Procedure: Fluid therapy optimization

• Registration Number: NCT03176680
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The goals of this study are to testify the effectiveness on enhancement recovery by new anesthetic ERAS (Enhanced recovery after surgery) strategy.

Detailed Description

ERAS (Enhanced recovery after surgery) strategy is extremely important for patients receiving esophagectomy including the preoperative preparation (smoking cessation, exercise prescription and nutrition prescription), intraoperative management, and postoperative analgesia and respiratory rehabilitation. However, despite the less invasive thoracoscopic esophagectomy and laparoscopic gastric tube reconstruction was developed, respiratory complications including acute lung injury (ALI) were observed up to 20% and associate with 50% of mortality. A new preventive anesthetic ERAS strategy including precise perioperative fluid management and preventive management after tracheal extubation should be developed.

Previous report indicated that none of the variables studied except fluid administration were shown as a risk factor for the development of respiratory complications on the multivariate analysis on esophageal surgery. However, there are rare prospective investigations of perioperative fluid administration strategy on postoperative complications after esophagectomy. Our group has studied on goal-directed fluid optimization and we found that the goal of optimization may differ for specific surgery. For esophagectomy, new anesthetic ERAS strategy should include precise preoptimized circulatory management and aggressive postoperative pulmonary care. Based on Frank-Starling law (stroke volume, SV, response to fluid therapy), a precise goal for perioperative goal-directed fluid therapy (GDFT) becomes possible in anesthetic practice. However, the effects of preoperative maximization of SV remain unknown. Following our study in last year, we planned to randomize 120 esophagectomy patients in the following 3 years into different GDFT groups (SV maximization and SV normalization groups). Postoperative THRIVE (Transnasal Humidified Rapid-Insufflation Ventilatory Exchange) therapy will be take place immediately after tracheal extubation. Blood samples will be obtained preoperatively to postoperative day 1 to measure lung injuries, kidney injuries as well as the inflammatory and oxidative markers. The clinical records will be collected (including extubation time, ICU stay, hospitalization days, 30-day mortality, 90-day mortality, readmission, postoperative cardiovascular, pulmonary, and renal complications, gastric tube related complications etc. ). The goals of this study are to testify the effectiveness on enhance recovery by new anesthetic ERAS strategy.

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-06-02
• Last Update Submitted: 2017-06-02
• Study First Posted: 2017-06-05
• Last Update Posted: 2017-06-05
• Study Start: 2017-06-15
• Primary Completion: 2020-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluid therapy optimization	Fluid therapy optimization	Fluid loading to optimize stroke volume after induction.

Primary Outcome Measures

Name	Time	Method
Postoperative complications	within 1 year after operation	Length of ICU stay, total hospitalization days, 30-day mortality, 90-day mortality, postoperative pulmonary complications, cardiovascular complications, renal complications, prolonged extubation, readmission, gastric tube related complications

Secondary Outcome Measures

Name	Time	Method
Inflammatory markers	Preoperative to postoperative day 1	Change in cytokines
Kidney injuries	Preoperative to postoperative day 1	Elevated plasma creatinine
Lung injuries	Preoperative to postoperative day 1	Change in the (PF ratio): ratio of arterial oxygen partial pressure (PaO2) to fractional inspired oxygen (FiO2)

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Test2, Taiwan