Post-auricular Versus Frontal Bispectral Index

NCT05451823 | Completed

• 1 other identifier: post-auricular bispectral
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

frontal bispectral index; post-auricular

Outcome Measures

Primary Outcomes (1)

• Post-auricular and frontal BIS values

  Post-auricular and frontal BIS values

  5 minutes before induction of aneasthesia

Study Arms (1)

Post auriclar-frontal

EXPERIMENTAL

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.

Device: Post auriclar-frontal

Interventions

Post auriclar-frontal DEVICE

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.

Post auriclar-frontal

Eligibility Criteria

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

You may qualify if:

• Patients aged≥18 years
• ASA I-III
• patients scheduled for elective renal surgeries

You may not qualify if:

• Patients with disabling central nervous system
• cerebrovascular disease
• those currently taking psychiatric medication
• those with a history of neurosurgical intervention
• those with contraindications for the placement of electrodes over forehead and post-auricular area (e.g., having skin infections)

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine, Tantan University Hospital

Tanta, Egypt

Location

Related Publications (1)

• Abdelrahman AMF, Elbadry AA, Omara AF. Comparison of post-auricular and frontal bispectral index values obtained during renal surgeries. BMC Anesthesiol. 2023 Dec 19;23(1):417. doi: 10.1186/s12871-023-02372-x.

  PMID: 38114941 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of anesthesiology, intensive care, and pain medicine

Study Record Dates

• First Submitted: June 26, 2022
• First Posted: July 11, 2022
• Study Start: July 1, 2022
• Primary Completion: January 30, 2023
• Study Completion: February 27, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)