Varied Remimazolam Dosages for Pediatric Endoscopy

NCT07083440 | Completed DMC

• 1 other identifier: ECH-2023-010
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastrointestinal Diseases

Keywords

Remimazolam; Painless gastrointestinal endoscopy; Sufentanil; Propofol; Pediatric

Outcome Measures

Primary Outcomes (2)

• Total Propofol Dosage

  Total amount of propofol (mg) administered during the gastroscopy procedure to maintain MOAA/S score ≤ 2.

  Periprocedural (during the gastroscopy procedure, lasting approximately 15-30 minutes)

• Incidence of Hypotension

  Percentage of patients experiencing hypotension, defined as a systolic blood pressure (SBP) decrease greater than 20% from baseline or below the 5th percentile for age, sustained for \>2 minutes, or requiring intervention.

  From induction of anesthesia through discharge from the Post-Anesthesia Care Unit (up to approximately 2 hours)

Secondary Outcomes (13)

• Hemodynamic Stability: Systolic Blood Pressure (SBP)

  From Baseline through discharge from the Post-Anesthesia Care Unit (up to approximately 2 hours post-procedure).

• Hemodynamic Stability: Diastolic Blood Pressure (DBP)

  From Baseline through discharge from the Post-Anesthesia Care Unit (up to approximately 2 hours post-procedure).

• Hemodynamic Stability: Heart Rate (HR)

  From Baseline through discharge from the Post-Anesthesia Care Unit (up to approximately 2 hours post-procedure).

• Success Rate of Sedation

  At the conclusion of the gastroscopy procedure

• Time to Induce Sedation

  During the induction of anesthesia (within the first 5 minutes)

Study Arms (3)

Remimazolam 0.2 mg/kg Group (R2)

EXPERIMENTAL

Experimental. Patients receive remimazolam 0.2 mg/kg.

Drug: Remimazolam; Drug: Propofol; Drug: Sufentanil

Remimazolam 0.3 mg/kg Group (R3)

EXPERIMENTAL

Experimental. Patients receive remimazolam 0.3 mg/kg.

Drug: Remimazolam; Drug: Propofol; Drug: Sufentanil

Remimazolam 0.4 mg/kg Group (R4)

EXPERIMENTAL

Experimental. Patients receive remimazolam 0.4 mg/kg.

Drug: Remimazolam; Drug: Propofol; Drug: Sufentanil

Interventions

Remimazolam DRUG

Intravenous bolus administered over 1 minute (prepared as a 1 mg/mL solution). Doses: 0.2 mg/kg, 0.3 mg/kg, or 0.4 mg/kg according to group allocation.

Remimazolam 0.2 mg/kg Group (R2); Remimazolam 0.3 mg/kg Group (R3); Remimazolam 0.4 mg/kg Group (R4)

Propofol DRUG

Intravenous (10 mg/mL emulsion), initial titrated dose ranging from 0.5 to 2 mg/kg, administered slowly until MOAA/S ≤ 2. Supplemental 0.5 mg/kg boluses as needed.

Remimazolam 0.2 mg/kg Group (R2); Remimazolam 0.3 mg/kg Group (R3); Remimazolam 0.4 mg/kg Group (R4)

Sufentanil DRUG

Intravenous dose of 0.1 µg/kg administered approximately 30 minutes before the start of the procedure.

Remimazolam 0.2 mg/kg Group (R2); Remimazolam 0.3 mg/kg Group (R3); Remimazolam 0.4 mg/kg Group (R4)

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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 sedation or cooperation.
• Patients who had participated in other clinical trials within the past 4 weeks.
• Contraindications to the planned endoscopic procedure (e.g., recent gastrointestinal perforation, bowel obstruction).

Sponsors & Collaborators

• Children's Hospital of Hebei Province: lead

Study Sites (1)

Hebei Children's Hospital

Shijiazhuang, Hebei, 050031, China

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

remimazolam; Propofol; Sufentanil

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 24, 2025
• Study Start: June 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: July 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)