MedPath

Esmketamine for profound and moderate sedation in pediatric patients.

Phase 4
Conditions
Outpatient Child sedation
Registration Number
ChiCTR2400088919
Lead Sponsor
Maternal and Child Health Hospital of Hubei Province
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) American Society of Anesthesiologists (ASA) grade ?-?; <br>(2) Children aged 0-5 years old; <br>(3) There were no gender restrictions for the subjects; <br>(4) No recent history of sedative usage; <br>(5) Body mass index (BMI) less than 25; <br>(6) No history of mental illness; <br>(7) Legal guardians must provide informed consent for sedation.<br>

Exclusion Criteria
  1. The family members of the children declined to provide informed consent for their participation in the trial.<br>2) Previous history of allergy to narcotic drugs, active ingredients, and excipients is present.<br>3) Patients with severe congenital heart disease and abnormal liver and kidney function are excluded.<br>4) Children with gastroesophageal reflux are not eligible for inclusion.<br>5) The presence of conscious disturbance is considered an exclusion criterion.<br>6) A history of nervous system disorders and mental illness is taken into account as an exclusion factor.<br>7) Individuals at serious risk of elevated blood pressure or intracranial pressure are excluded from the study.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
heart rate;oxygen saturation;blood pressure;
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath