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Completed

NCT Number: NCT03397745

Bispectral Index Throughout Esophageal Cancer Operation

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.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung medical center

Seoul, 06351, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIS

Device

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Which Bispectral Index Score is Reliable Throughout Esophageal Cancer Operation?

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 12, 2018
Registry last updated
Sep 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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