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Bispectral Index Throughout Esophageal Cancer Operation

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ClinicalTrials.gov Identifier: NCT03397745
Recruitment Status : Completed
First Posted : January 12, 2018
Last Update Posted : September 4, 2018
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Device: BIS Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Which Bispectral Index Score is Reliable Throughout Esophageal Cancer Operation?
Actual Study Start Date : January 15, 2018
Actual Primary Completion Date : August 3, 2018
Actual Study Completion Date : August 3, 2018

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Arms and Interventions
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Arm Intervention/treatment
BIS group
Patients who received the esophageal surgery
 Device: BIS
All patients applied BIS on both side (Left and Right)


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. the asymmetry of BIS [ Time Frame: after supine position 5 mins, 10 mins, 20 mins, 30 mins ]
    The difference of BIS on supine position

  2. oxygenation and BIS [ Time Frame: intraoperative ]
    the effects of arterial blood gas analysis (O2 mmH2O and CO2 mmH2O) on BIS

  3. The changes of BIS [ Time Frame: intraoperative ]
    the difference of BIS divided to 3 BIS level ( <40,40-60,>60)


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397745


Locations
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Korea, Republic of
Samsung medical center
Seoul, Korea, Republic of, 06351
Sponsors and Collaborators
Samsung Medical Center
More Information
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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03397745    
Other Study ID Numbers: SMC2017-12-033
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: September 4, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samsung Medical Center:
bispectral index
lateral decubitus position
one lung ventilation
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases