Esophageal CancerNCT03397745
Bispectral Index Throughout Esophageal Cancer Operation
A study testing BIS in people with Esophageal Cancer, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- BIS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jan 2018to 3 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patients who are planned the esophageal cancer operation
Who cannot join
- patient who has dermatitis
- patient who refuse to participate in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Which Bispectral Index Score is Reliable 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.
Read the 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.
- Conditions
- Esophageal Cancer
- Being tested
- BIS
- Keywords
- bispectral index, lateral decubitus position, one lung ventilation
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BISDevice
All patients applied BIS on both side (Left and Right)
| Study group | Role | What they receive |
|---|---|---|
| BIS group | Other | Patients who received the esophageal surgery Receives: Device: BIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bispectral index score
The difference of both side BIS value on lateral decubitus position
Measured: after lateral decubitus position 5 mins, 10 mins, 20 mins, 30 mins
Secondary outcomes (3)
the asymmetry of BIS
The difference of BIS on supine position
Measured: after supine position 5 mins, 10 mins, 20 mins, 30 mins
oxygenation and BIS
the effects of arterial blood gas analysis (O2 mmH2O and CO2 mmH2O) on BIS
Measured: intraoperative
The changes of BIS
the difference of BIS divided to 3 BIS level ( <40,40-60,>60)
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start15 Jan 2018
- Primary completion3 Aug 2018
- Study completion3 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397745
- Sponsor's protocol ID
- SMC2017-12-033
- Status last verified
- Jan 2018
- First submitted
- 2 Jan 2018
- Last updated
- 4 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Bispectral Index Score is Reliable Throughout Esophageal Cancer Operation?
- ClinicalTrials.gov ID
- NCT03397745
- Acronym / sponsor ID
- SMC2017-12-033
- Conditions
- Esophageal Cancer
- Keywords
- bispectral index, lateral decubitus position, one lung ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 3 Aug 2018 (actual)
- Study completion
- 3 Aug 2018 (actual)
- First posted
- 12 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIS group | Other | Device: BISPatients who received the esophageal surgery |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- the patients who are planned the esophageal cancer operation
Key exclusion criteria (2 listed)
- patient who has dermatitis
- patient who refuse to participate in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BISAll patients applied BIS on both side (Left and Right) | Device | BIS group |
Primary outcome
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
3 secondary outcomes
the asymmetry of BIS
Time frame: after supine position 5 mins, 10 mins, 20 mins, 30 mins
oxygenation and BIS
Time frame: intraoperative
The changes of BIS
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIS in people with Esophageal Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bispectral index score (time frame: after lateral decubitus position 5 mins, 10 mins, 20 mins, 30 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2018.