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Bispectral Index Throughout Esophageal Cancer Operation

Primary Purpose

Esophageal Cancer

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

BIS

About this trial

This is an interventional other trial for Esophageal Cancer focused on measuring bispectral index, lateral decubitus position, one lung ventilation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Samsung medical center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

BIS group

Arm Description

Patients who received the esophageal surgery

Outcomes

Primary Outcome Measures

Change in Bispectral index score

The difference of both side BIS value on lateral decubitus position

Secondary Outcome Measures

the asymmetry of BIS

The difference of BIS on supine position

oxygenation and BIS

the effects of arterial blood gas analysis (O2 mmH2O and CO2 mmH2O) on BIS

The changes of BIS

the difference of BIS divided to 3 BIS level ( <40,40-60,>60)

Full Information

NCT ID

NCT03397745

First Posted

January 2, 2018

Last Updated

August 30, 2018

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03397745

Brief Title

Bispectral Index Throughout Esophageal Cancer Operation

Official Title

Which Bispectral Index Score is Reliable Throughout Esophageal Cancer Operation?

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

January 15, 2018 (Actual)

Primary Completion Date

August 3, 2018 (Actual)

Study Completion Date

August 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer

Keywords

bispectral index, lateral decubitus position, one lung ventilation

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BIS group

Arm Type

Other

Arm Description

Patients who received the esophageal surgery

Intervention Type

Device

Intervention Name(s)

BIS

Intervention Description

All patients applied BIS on both side (Left and Right)

Primary Outcome Measure Information:

Title

Change in Bispectral index score

Description

The difference of both side BIS value on lateral decubitus position

Time Frame

after lateral decubitus position 5 mins, 10 mins, 20 mins, 30 mins

Secondary Outcome Measure Information:

Title

the asymmetry of BIS

Description

The difference of BIS on supine position

Time Frame

after supine position 5 mins, 10 mins, 20 mins, 30 mins

Title

oxygenation and BIS

Description

the effects of arterial blood gas analysis (O2 mmH2O and CO2 mmH2O) on BIS

Time Frame

intraoperative

Title

The changes of BIS

Description

the difference of BIS divided to 3 BIS level ( <40,40-60,>60)

Time Frame

intraoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Samsung medical center

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

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Bispectral Index Throughout Esophageal Cancer Operation

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