- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03397745
Bispectral Index Throughout Esophageal Cancer Operation
Which Bispectral Index Score is Reliable Throughout Esophageal Cancer Operation?
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMC2017-12-033
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
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OHSU Knight Cancer InstituteOregon Health and Science UniversityWithdrawnStage IIB Esophageal Cancer AJCC v7 | Stage III Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IIIC Esophageal Cancer AJCC v7
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