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Comparison of Bi spectral Index Electrode Placements at Frontal?Mandibular and Frontal?Postauricular sites with an intergroup and an intra group analysis for signal superiority in ASA I and II Adult neurosurgery patients

Analyzing bispectral index electrode placement: Comparisons between frontal and mandibular v/s frontal and postauricular locations, followed by intergroup analysis - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094482
Enrollment
130
Registered
2025-09-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhere

Interventions

Intervention1: Post auricular electrode: The post auricular electrode will be compared with the standard frontal electrode Intervention2: Mandibular electrode: The mandibular electrode will be placed

Sponsors

Artemis Health Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 and above and below 65 yrs 2. ASA physical status I or II 3. Scheduled for various neurosurgical , cranial and spinal procedures

Exclusion criteria

Exclusion criteria: 1. Presence of skin lesions or scars at potential sensor sites that could impede sensor placement or function. 2. Allergies: Known hypersensitivity to adhesives or materials used in BIS sensors. 3. Bearded individuals for mandibular placement of electrodes? 4. GCS less than 15

Design outcomes

Primary

MeasureTime frame
The primary aim of this study is to evaluate the validity of alternative placements of the Bispectral Index sensor?specifically the mandibular and post auricular positions?compared to the traditional frontal placement, in measuring the depth of anesthesia during surgical procedures. Timepoint: The time points would be the following 1. Baseline 2. 90 seconds after administration of fentanyl and propofol 3. 3 mins after giving muscle relaxant 4. At intubation 5. At the time of first pain stimulus 6. Every 30 s into the procedure 7. At extubation

Secondary

MeasureTime frame
Practicality of Sensor Placement: Evaluate the practicality of each sensor placement in terms of ease of application, stability of the sensor during operation, & incidence of needing to reposition the sensor. Impact on Clinical Decision-Making: Investigate whether the sensor placement impacts clinical decision-making, particularly decisions regarding adjustments in anesthetic dosage based on BIS readings & arrive at recommendations.Timepoint: Baseline 2. 90 seconds after administration of fentanyl & propofol 3. 3 mins after giving muscle relaxant 4. At intubation 5. At the time of first pain stimulus 6. Every 30 s into the procedure 7. At extubation

Countries

India

Contacts

Public ContactShivani Fotedar

Artemis Health Institute

dr.shivani.fotedar@gmail.com01244511111

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026