Monitoring of Depth of AnesthesiaNCT07013734
Patient Positioning and Its Influence on BIS, NOL, and Cerebral Oxygenation in Anesthetized Patients
An observational study of Monitoring of Depth of Anesthesia, run by Ciusss de L'Est de l'Île de Montréal.
Trial summary
The goal of this observational study is to find out how changes in body position during surgery might affect brain monitoring results in patients who are under general anesthesia.The main question it aims to answer is: Does patient positioning have an impact on Bispectral Index (BIS) and Nociception Level (NOL) index… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Monitoring of Depth of Anesthesia
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from Maisonneuve-Rosemont Hospital undergoing elective surgery.
Who may be able to join
- Adult patients above 18 years old able to consent;
- Supine or lithotomy positioning during the surgery;
Who cannot join
- Patient with Body Mass Index (BMI) ≥ 35;
- Patients over 80 years old.
About this study
The goal of this observational study is to find out how changes in body position during surgery might affect brain monitoring results in patients who are under general anesthesia.The main question it aims to answer is:
- Does patient positioning have an impact on Bispectral Index (BIS) and Nociception Level (NOL) index monitoring (which are values of awareness in anesthesized patients).
Read more
Participants will undergo their surgery as planned, except for these extra features:
- Extra monitors placed to check brain activity, pain response, and brain oxygen levels.
- Before and after the surgery, while the patient is asleep, the patient's table will be moved into two different positions for 2 minutes each to see if the values on the monitor change.
- Hard data of the monitors will be extracted and analyzed to evaluate any possible correlation between the position of the patient and brain monitoring results.
Participants will then have to answer a short questionnaire after surgery about their memories before and after the anesthesia.
- Conditions
- Monitoring of Depth of Anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in Bispectral Index (BIS)
Measured: Perioperative period
Secondary outcomes (2)
Variation of Nociception Level (NOL) Index
Measured: Perioperative period
Variation of the patient's cerebral saturation measured with cerebral oximetry
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study startAug 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monitoring of Depth of AnesthesiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013734
- Sponsor's protocol ID
- 2025-3803
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Positioning and Its Influence on BIS, NOL, and Cerebral Oxygenation in Anesthetized Patients
- ClinicalTrials.gov ID
- NCT07013734
- Acronym / sponsor ID
- 2025-3803
- Conditions
- Monitoring of Depth of Anesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 10 Jun 2025 (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 goal of this observational study is to find out how changes in body position during surgery might affect brain monitoring results in patients who are under general anesthesia.The main question it aims to answer is:
- Does patient positioning have an impact on Bispectral Index (BIS) and Nociception Level (NOL) index monitoring (which are values of awareness in anesthesized patients).
Participants will undergo their surgery as planned, except for these extra features:
- Extra monitors placed to check brain activity, pain response, and brain oxygen levels.
- Before and after the surgery, while the patient is asleep, the patient's table will be moved into two different positions for 2 minutes each to see if the values on the monitor change.
- Hard data of the monitors will be extracted and analyzed to evaluate any possible correlation between the position of the patient and brain monitoring results.
Participants will then have to answer a short questionnaire after surgery about their memories before and after the anesthesia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from Maisonneuve-Rosemont Hospital undergoing elective surgery.
Key inclusion criteria (2 listed)
- Adult patients above 18 years old able to consent;
- Supine or lithotomy positioning during the surgery;
Key exclusion criteria (2 listed)
- Patient with Body Mass Index (BMI) ≥ 35;
- Patients over 80 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Variation in Bispectral Index (BIS)
Time frame: Perioperative period
2 secondary outcomes
Variation of Nociception Level (NOL) Index
Time frame: Perioperative period
Variation of the patient's cerebral saturation measured with cerebral oximetry
Time frame: Perioperative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Monitoring of Depth of Anesthesia, run by Ciusss de L'Est de l'Île de Montréal.
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 2 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: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Variation in Bispectral Index (BIS) (time frame: Perioperative period). 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 7 Aug 2026.