General Anesthetics-related Changes in Prefrontal EEG During Pediatric Surgical Anesthesia

• ClinicalTrials.gov Identifier: NCT05210764
• Recruitment Status: Not yet recruiting
• First Posted: January 27, 2022
• Last Update Posted: April 20, 2022
• Sponsor: Peking University First Hospital
• Information provided by (Responsible Party): Dong-Xin Wang, Peking University First Hospital

Tracking Information

• First Submitted Date: January 9, 2022
• First Posted Date: January 27, 2022
• Last Update Posted Date: April 20, 2022
• Estimated Study Start Date: June 2022
• Estimated Primary Completion Date: March 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 14, 2022)

• phase-amplitude coupling [ Time Frame: induction and maintenance of anesthesia ]
  phase-amplitude coupling
• bicoherence [ Time Frame: induction and maintenance of anesthesia ]
  bicoherence

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: General Anesthetics-related Changes in Prefrontal EEG During Pediatric Surgical Anesthesia
• Official Title: General Anesthetics-related Changes in Prefrontal EEG During Pediatric Surgical Anesthesia
• Brief Summary: The change profiles of indices derived from pEEG such as phase-amplitude coupling and bicoherence based on individual general anesthetics in children have not been examined in previous literature. Whether those indices have the abilities to predict individual drug-related anesthesia depth in children need to be explored.
• Detailed Description: The need to maintain a proper depth of general anesthesia during pediatric surgery is an important aspect of anesthesiology. An inappropriate anesthesia depth increases the risk of intraoperative awareness or delay in recovery in children undergoing surgery. Current modalities for anesthesia depth monitoring showed limited accuracy in children. The electroencephalogram (EEG) can be analyzed in its raw form for characteristic drug-induced patterns of change or summarized using mathematical parameters as a processed electroencephalogram (pEEG). The change profiles of indices derived from pEEG such as phase-amplitude coupling and bicoherence based on individual general anesthetics in children have not been examined in previous literature. Whether those indices have the abilities to predict individual drug-related anesthesia depth in children need to be explored.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Children aged 3-7 years, American Society of Anesthesiologists Physical Status I-II, scheduled for elective surgery in Peking University First Hospital

Condition

• General Anesthetic
• Electroencephalogram

Intervention

• Drug: propofol
  General anesthesia is induced and maintained mainly with propofol.
  Other Name: Propofol anesthesia group
• Drug: sevoflurane
  General anesthesia is induced and maintained mainly with sevoflurane.
  Other Name: Sevoflurane anesthesia group
• Drug: S-ketamine
  General anesthesia is induced mainly with S-ketamine and maintained mainly with propofol.
  Other Name: S-ketamine anesthesia group

Study Groups/Cohorts

• propofol
  General anesthesia is induced and maintained mainly with propofol.
  Intervention: Drug: propofol
• sevoflurane
  General anesthesia is induced and maintained mainly with sevoflurane.
  Intervention: Drug: sevoflurane
• ketamine
  General anesthesia is induced mainly with S-ketamine and maintained mainly with propofol.
  Intervention: Drug: S-ketamine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: January 14, 2022): 90
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2024
• Estimated Primary Completion Date: March 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Children aged 3-7 years, American Society of Anesthesiologists Physical Status I-II, scheduled for elective surgery in Peking University First Hospital.

Exclusion Criteria:

• Preterm patients;
• Height and weight not within the standard ranges for respective ages;
• Surgery for head or heart;
• Operation duration of <20min or >2h;
• Patients with muscular, neurologic or psychiatric diseases;
• Patients with Congenital anomaly or hereditary diseases;
• Patients with medication abuse;
• Allergy to medication including propofol, sevoflurane, and ketamine;
• Allergy to beans;
• Refusal to participate the study by guardians.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 3 Years to 7 Years (Child)
• Accepts Healthy Volunteers: No

Contacts

Contact: Linlin Song, MD; 86-13501309217; songlinlinlynkia@163.com

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05210764
• Other Study ID Numbers: 2022-01-08
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Dong-Xin Wang, Peking University First Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Peking University First Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Dong-Xin Wang, MD, PhD; Peking University First Hospital

• PRS Account: Peking University First Hospital
• Verification Date: April 2022