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Bispectral Index Throughout Esophageal Cancer Operation

Which Bispectral Index Score is Reliable Throughout Esophageal Cancer Operation?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03397745
Enrollment
44
Registered
2018-01-12
Start date
2018-01-15
Completion date
2018-08-03
Last updated
2018-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

bispectral index, lateral decubitus position, one lung ventilation

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.

Interventions

DEVICEBIS

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

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change in Bispectral index scoreafter lateral decubitus position 5 mins, 10 mins, 20 mins, 30 minsThe difference of both side BIS value on lateral decubitus position

Secondary

MeasureTime frameDescription
the asymmetry of BISafter supine position 5 mins, 10 mins, 20 mins, 30 minsThe difference of BIS on supine position
oxygenation and BISintraoperativethe effects of arterial blood gas analysis (O2 mmH2O and CO2 mmH2O) on BIS
The changes of BISintraoperativethe difference of BIS divided to 3 BIS level ( \<40,40-60,\>60)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026