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Clinical Trials/NCT03397745
NCT03397745CompletedNot Applicable

Which Bispectral Index Score is Reliable Throughout Esophageal Cancer Operation?

Samsung Medical Center2 sites in 1 country44 target enrollmentStarted: January 15, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
44
Locations
2
Primary Endpoint
Change in Bispectral index score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

BIS group

Other

Patients who received the esophageal surgery

Intervention: BIS (Device)

Outcomes

Primary Outcomes

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 Outcomes

  • oxygenation and BIS(intraoperative)
  • the asymmetry of BIS(after supine position 5 mins, 10 mins, 20 mins, 30 mins)
  • The changes of BIS(intraoperative)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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