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

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ClinicalTrials.gov Identifier: NCT05210764
Recruitment Status : Not yet recruiting
First Posted : January 27, 2022
Last Update Posted : April 20, 2022
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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