Bispectral Index Throughout Esophageal Cancer Operation

Not Applicable

Completed

• Conditions: Esophageal Cancer
• Interventions: Device: BIS

• Registration Number: NCT03397745
• Lead Sponsor: Samsung Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2018-01
• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-12
• Study Start: 2018-01-15
• Primary Completion: 2018-08-03
• Study Completion: 2018-08-03
• Last Update Submitted: 2018-08-30
• Last Update Posted: 2018-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

the patients who are planned the esophageal cancer operation

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BIS group	BIS	Patients who received the esophageal surgery

Primary Outcome Measures

Name	Time	Method
Change in Bispectral index score	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

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

Trial Locations

Locations (1)

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of