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Post-auricular Versus Frontal Bispectral Index

NCT05451823 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-09-11

No results posted yet for this study

Summary

Electroencephalogram (EEG) derived monitors during practice of general anesthesia; allow the titration and maintenance of an adequate depth of anesthesia, advantages from reducing the recovery time after waking, as well as the risk of anesthetics adverse events .

There are various types of EEG-derived monitoring devices that are used to monitor the depth of anesthesia, and among the established devices is bispectral index (BIS) monitor. It is a quantitative electroencephalographic device that is widely used to assess the hypnotic component of anesthesia, and a level between 40 and 60 is recommended for an adequate level of the hypnotic state.

However, the use of BIS in certain surgeries is challenging because of the proximity of the forehead sensor to the surgical site. There are high possibilities of interruption of BIS recording due to contamination of the forehead sensor with blood or antiseptic cleaning solution. At the same time, the design and size of a BIS forehead sensor in the form of a long strip can also interfere with the site of surgical incision.

Several alternative BIS sensor placements have been studied for cases in which the frontal setup is not feasible. However, few studies studied the placement of the BIS sensor at the post-auricular area as an alternative method of monitoring the depth of anesthesia.

Conditions

  • Renal Surgeries

Interventions

DEVICE

Post auriclar-frontal

Frontal sensors will be applied with lead 1 at the center of the forehead; lead 2, 2.8 cm lateral to lead 1; and lead 3 at the temporal area between the lateral canthus and the hairline. Post auriclar sensors will be applied to the same side of the face, with lead 1 approximately 2.5 cm medial to the mastoid area, post-auricularly next to the hairline. Lead 2 will be attached at the mastoid area and lead 3 will be attached on the same side at the temporal area between the lateral canthus and the hairline.

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2023-01-30
Completion
2023-02-27

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05451823 on ClinicalTrials.gov