EEG to Monitor Propofol Anesthetic Depth in Infants and Toddlers

NCT ID: NCT05701748

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-03
• Study Completion Date: 2025-01-01

Brief Summary

The goal of this study is monitor anesthetic depth of children undergoing propofol anesthesia using electroencephalography (EEG). The main questions it aims to answer are:

1. EEG spectral edge frequency (SEF95) readings where 50% of patients do not respond to three stimuli.

2. The propofol blood concentration that corresponds to each of the three EEG SEF95 readings Participants will undergo EEG monitoring, stimuli (placement of oral pacifier, electrical stimulation, and laryngoscopy), and blood collection.

Detailed Description

Sevoflurane inhalation and propofol intravenous anesthesia are the mainstays of delivering general anesthesia in children. Propofol anesthesia in children is gaining popularity due to fewer respiratory complications, less post-operative nausea vomiting and emergence delirium, compared to sevoflurane. However, unlike sevoflurane, the pharmacodynamics of propofol is less studied in infants and toddlers, particularly the biomarker for propofol brain effect site concentration (Ce), indicative of anesthetic depth. The lack of a real-time biomarker often results in over- or under-dosing of propofol in clinical practice. The goal of this study is to utilize electroencephalography (EEG) as the biomarker of propofol effect site concentration and clinical anesthetic depth, thereby improving the safety and efficacy of propofol anesthesia in this population. In infants and toddlers receiving propofol anesthesia, EEG will be recorded while the patient undergoes three stimuli used to assess anesthetic depth (placement of oral pacifier, electrical stimulation, and laryngoscopy). The EEG index (spectral edge frequency-SEF95) where 50% of patients (ED50) do not respond to each of the three stimuli will be determined as the biomarker of propofol clinical anesthetic depth. In the same cohort, the regression between EEG SEF95 and plasma propofol levels will be determined to assess relationship between EEG SEF95 and propofol Ce.

Conditions

Electroencephalography Spectral Edge Frequency; Anesthetic Depth

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EEG SEF95 values in response to stimuli

EEG SEF95 values that correspond to the three stimuli being applied, separately enrolled and analyzed for the 3-12mo and 13-24 age groups.

Group Type: EXPERIMENTAL

Stimuli

Intervention Type: OTHER

placement of oral pacifier, electrical stimulation, and laryngoscopy

Interventions

Stimuli

placement of oral pacifier, electrical stimulation, and laryngoscopy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Children 3 to 24 month old undergoing surgery.

2. Planned laryngoscopy and endotracheal intubation or laryngeal mask airway (LMA) placement for clinical care.

3. Planned propofol anesthesia for anesthesia maintenance.

4. American Society of Anesthesiologists (ASA ) < III.

5. Muscle relaxant not indicated per planned clinical care for laryngoscopy/intubation or LMA.

6. Anticipated surgery duration approximately < 2h40min

Exclusion Criteria

1. Patients undergoing emergency surgery.

2. Known severe neurological disease which might result in abnormal EEG SEF.

3. Deformities of forehead (difficult EEG sensor placement).

4. Known difficult airway.

5. Allergy to propofol.

6. Attending anesthesiologist on record caring for patient plans to administer additional IV medication besides propofol during study phase.

7. Currently on anti-seizure medication (might alter propofol pharmacodynamics).

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian Yuan, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

22-019941

Identifier Type: -

Identifier Source: org_study_id