MedDataX Logo

Different Anesthetic Managements of Esophageal Resection and Reconstruction

NCT ID: NCT02961140

Last Updated: 2016-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia Esophagus Cancer Postoperative Complications

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Outcome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cardiac Output Maximization

maximize stroke volume, and maintain cardiac index and stroke volume variation during the whole operation

Group Type EXPERIMENTAL

Cardiac Output Maximization

Intervention Type OTHER

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

keep cardiac index (CI) ≥ 2.2, and maintain CI and stroke volume variation during the whole operation

Group Type ACTIVE_COMPARATOR

Cardiac Output Normalization

Intervention Type OTHER

The investigator will administer intravenous fluids to keep cardiac index (CI) ≥ 2.2, and maintain CI and stroke volume variation during the whole operation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ya-jung Cheng, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ya-jung Cheng, M.D., Ph.D

Role: CONTACT

Phone: +886-2-23123456

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201512052RINB

Identifier Type: -

Identifier Source: org_study_id