Different Anesthetic Managements of Esophageal Resection and Reconstruction

November 8, 2016 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cardiac Output Maximization
maximize stroke volume, and maintain cardiac index and stroke volume variation during the whole operation
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.
Active Comparator: Cardiac Output Normalization
keep cardiac index (CI) ≥ 2.2, and maintain CI and stroke volume variation during the whole operation
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative complication
Time Frame: 1 month
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
Time Frame: 1 day
Incidence of intraoperative shock, use of vasopressor or inotropic agents
1 day
Length of stay
Time Frame: 1 month
Intensive care unit length of stay and hospital stay
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

Ministry of Science and Technology, Taiwan

Investigators

  • Principal Investigator: Ya-jung Cheng, M.D., Ph.D, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

November 6, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (Estimate)

November 10, 2016

Study Record Updates

Last Update Posted (Estimate)

November 10, 2016

Last Update Submitted That Met QC Criteria

November 8, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201512052RINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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