Bispectral Index Throughout Esophageal Cancer Operation

Esophageal Cancer Clinical Trial

Official title:

Which Bispectral Index Score is Reliable Throughout Esophageal Cancer Operation?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03397745
• Other study ID #: SMC2017-12-033
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: August 3, 2018

Study information

• Verified date: January 2018
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 3, 2018
• Est. primary completion date: August 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Bispectral index score	The difference of both side BIS value on lateral decubitus position	after lateral decubitus position 5 mins, 10 mins, 20 mins, 30 mins
Secondary	the asymmetry of BIS	The difference of BIS on supine position	after supine position 5 mins, 10 mins, 20 mins, 30 mins
Secondary	oxygenation and BIS	the effects of arterial blood gas analysis (O2 mmH2O and CO2 mmH2O) on BIS	intraoperative
Secondary	The changes of BIS	the difference of BIS divided to 3 BIS level ( <40,40-60,>60)	intraoperative