Patient Positioning and Its Influence on BIS, NOL, and Cerebral Oxygenation in Anesthetized Patients

NCT07013734 | Not Yet Recruiting

• 1 other identifier: 2025-3803
• Study Type: observational
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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 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 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. 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

Outcome Measures

Primary Outcomes (1)

• Variation in Bispectral Index (BIS)

  Perioperative period

Secondary Outcomes (2)

• Variation of Nociception Level (NOL) Index

  Perioperative period

• Variation of the patient's cerebral saturation measured with cerebral oximetry

  Perioperative period

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients from Maisonneuve-Rosemont Hospital undergoing elective surgery.

You may qualify if:

• Fully consented, adult patients above 18 years old;
• Supine positioning during the surgery;
• Surgery requiring patient positioning with Vacuform mats.

You may not qualify if:

• Patient with Body Mass Index (BMI) ≥ 35;
• Patients over 80 years old.

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: June 10, 2025
• Study Start: August 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-04