Bispectral Index Throughout Esophageal Cancer Operation

August 30, 2018 updated by: Samsung Medical Center

Which Bispectral Index Score is Reliable Throughout Esophageal Cancer Operation?

The investigators try to conduct a study to assess the impact of changing patients' lateral decubitus position on BIS readings during esophageal cancer operation. Also, the investigators evaluate the effects of one-lung ventilation and total lung ventilation on BIS value with inhalation agent.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bispectral index (BIS) was developed to monitor a patient's level of consciousness under general anesthesia. Several factors have been found to alter BIS readings without affecting the depth of anesthesia.Changing a patient's position (head up and head down) significantly affects the BIS values, which might affect the interpretation of anesthetic depth.

During esophageal cancer surgery, there were several factors which could affect to BIS values.First, the surgical positions are consisted with supine and lateral decubitus position more than 1 h. Thus, the investigators compare the BIS value of both side on supine and lateral decubitus position by both side approach. Second, the one lung ventilation was applied for surgical filed. It alters the oxygenation and the cerebral flow. Because of these effects, the BIS monitoring can differ by the period of surgery. Thus, in this study, the BIS value of both side monitor throughout the surgery.

Study Type

Interventional

Enrollment (Actual)

44

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.

Study Locations

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

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

the patients who are planned the esophageal cancer operation

Exclusion Criteria:

  • patient who has dermatitis
  • patient who refuse to participate in this study

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: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: BIS group
Patients who received the esophageal surgery
All patients applied BIS on both side (Left and Right)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Bispectral index score
Time Frame: after lateral decubitus position 5 mins, 10 mins, 20 mins, 30 mins
The difference of both side BIS value on lateral decubitus position
after lateral decubitus position 5 mins, 10 mins, 20 mins, 30 mins

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the asymmetry of BIS
Time Frame: after supine position 5 mins, 10 mins, 20 mins, 30 mins
The difference of BIS on supine position
after supine position 5 mins, 10 mins, 20 mins, 30 mins
oxygenation and BIS
Time Frame: intraoperative
the effects of arterial blood gas analysis (O2 mmH2O and CO2 mmH2O) on BIS
intraoperative
The changes of BIS
Time Frame: intraoperative
the difference of BIS divided to 3 BIS level ( <40,40-60,>60)
intraoperative

Collaborators and Investigators

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

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 (Actual)

January 15, 2018

Primary Completion (Actual)

August 3, 2018

Study Completion (Actual)

August 3, 2018

Study Registration Dates

First Submitted

January 2, 2018

First Submitted That Met QC Criteria

January 11, 2018

First Posted (Actual)

January 12, 2018

Study Record Updates

Last Update Posted (Actual)

September 4, 2018

Last Update Submitted That Met QC Criteria

August 30, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Esophageal Cancer

Clinical Trials on BIS

3
Subscribe