Patient Positioning and Its Influence on BIS, NOL, and Cerebral Oxygenation in Anesthetized Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Monitoring of Depth of Anesthesia. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Variation in Bispectral Index (BIS) [Time frame: Perioperative period]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- Adult patients above 18 years old able to consent;
- Supine or lithotomy positioning during the surgery;
Exclusion criteria
- Patient with Body Mass Index (BMI) ≥ 35;
- Patients over 80 years old.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07013734 · 2025-3803