Varied Remimazolam Dosages for Pediatric Endoscopy
China180 participantsStarted 2023-06-01
Plain-language summary
This prospective, randomized, comparative study aims to compare the efficacy and safety of three different doses of remimazolam (0.2 mg/kg, 0.3 mg/kg, and 0.4 mg/kg) combined with sufentanil and propofol for painless gastroscopy in pediatric patients. The study will assess sedation quality, propofol consumption, hemodynamic stability, and adverse event profiles to identify an optimal remimazolam dosing regimen.
Who can participate
Age range3 Years – 17 Years
SexALL
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Inclusion Criteria:
* Patients scheduled for elective gastrointestinal endoscopy under anesthesia.
* Patients classified as American Society of Anesthesiologists (ASA) physical status I or II.
* Patients aged 3 to under 18 years of age.
* Written informed consent provided by parents or legal guardians.
Exclusion Criteria:
* Patients with known or suspected difficult airway, severe systemic disease (ASA ≥ III).
* Uncorrected significant abnormal liver or kidney function that could significantly alter drug metabolism (e.g., AST/ALT \> 2x upper limit of normal, eGFR \< 30 mL/min/1.73m²).
* Known allergy to study medications (remimazolam, propofol, sufentanil, or their components including egg or soy for propofol).
* Congenital illnesses such as severe congenital heart disease, or other conditions that may impact treatment observation or increase anesthetic risk.
* Patients who were obese (defined as BMI \> 95th percentile for age and sex) or severely malnourished (BMI \< 3rd percentile for age and sex).
* Patients who had taken sedatives, opioid analgesics (other than prescribed for chronic pain), or psychotropic medications (e.g., antidepressants, antipsychotics) within 24 hours prior to the procedure (unless part of their regular, stable medication regimen for a chronic condition, as assessed and deemed safe by the anesthesiologist).
* Patients with pre-existing severe, uncontrolled mental illness or significant cognitive dysfunction that would preclude assessment of sedati…
What they're measuring
1
Total Propofol Dosage
Timeframe: Periprocedural (during the gastroscopy procedure, lasting approximately 15-30 minutes)
2
Incidence of Hypotension
Timeframe: From induction of anesthesia through discharge from the Post-Anesthesia Care Unit (up to approximately 2 hours)