A Clinical Investigation of Varied Remimazolam Dosages With Sufentanil and Propofol for Painless Pediatric Gastrointestinal Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Total Propofol Dosage
研究概览
简要总结
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.
详细描述
Pediatric patients undergoing gastrointestinal endoscopy often require deep sedation. Propofol is commonly used but can cause injection pain, respiratory depression, and hemodynamic instability. Remimazolam, a novel ultra-short-acting benzodiazepine, offers rapid onset, predictable recovery, and potentially better hemodynamic stability. This study investigates three doses of remimazolam (0.2 mg/kg, 0.3 mg/kg, and 0.4 mg/kg) co-administered with sufentanil (0.1 µg/kg) and titrated propofol to achieve a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤ 2 in 180 pediatric patients (ASA I-II, aged <18 years) undergoing gastroscopy. Patients are randomly assigned to one of three remimazolam dose groups. The study will evaluate total propofol dosage, hemodynamic changes (blood pressure, heart rate), time to sedation, awakening and recovery times, incidence of adverse events (e.g., hypotension, respiratory depression, injection pain), and satisfaction scores. The goal is to determine a remimazolam dose that provides effective sedation with reduced propofol requirements and an improved safety profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Remimazolam 0.2 mg/kg Group (R2)
Experimental. Patients receive remimazolam 0.2 mg/kg.
干预措施: Remimazolam (Drug)
Remimazolam 0.2 mg/kg Group (R2)
Experimental. Patients receive remimazolam 0.2 mg/kg.
干预措施: Propofol (Drug)
Remimazolam 0.2 mg/kg Group (R2)
Experimental. Patients receive remimazolam 0.2 mg/kg.
干预措施: Sufentanil (Drug)
Remimazolam 0.3 mg/kg Group (R3)
Experimental. Patients receive remimazolam 0.3 mg/kg.
干预措施: Remimazolam (Drug)
Remimazolam 0.3 mg/kg Group (R3)
Experimental. Patients receive remimazolam 0.3 mg/kg.
干预措施: Propofol (Drug)
Remimazolam 0.3 mg/kg Group (R3)
Experimental. Patients receive remimazolam 0.3 mg/kg.
干预措施: Sufentanil (Drug)
Remimazolam 0.4 mg/kg Group (R4)
Experimental. Patients receive remimazolam 0.4 mg/kg.
干预措施: Remimazolam (Drug)
Remimazolam 0.4 mg/kg Group (R4)
Experimental. Patients receive remimazolam 0.4 mg/kg.
干预措施: Propofol (Drug)
Remimazolam 0.4 mg/kg Group (R4)
Experimental. Patients receive remimazolam 0.4 mg/kg.
干预措施: Sufentanil (Drug)
结局指标
主要结局
Total Propofol Dosage
时间窗: Periprocedural (during the gastroscopy procedure, lasting approximately 15-30 minutes)
Total amount of propofol (mg) administered during the gastroscopy procedure to maintain MOAA/S score ≤ 2.
Incidence of Hypotension
时间窗: From induction of anesthesia through discharge from the Post-Anesthesia Care Unit (up to approximately 2 hours)
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.
次要结局
- Hemodynamic Stability: Systolic Blood Pressure (SBP)(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))
- Awakening Time(Immediately following the end of the procedure)
- Recovery Time in PACU(Throughout the Post-Anesthesia Care Unit stay (up to 90 minutes))
- Number of Patients Requiring Supplemental Propofol Boluses(During the gastroscopy procedure)
- Incidence of Respiratory Depression(From induction of anesthesia until emergence)
- Incidence of Injection Pain(During intravenous drug administration at induction)
- 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).)
- Incidence of Postoperative Nausea and Vomiting (PONV)(Assessed in the Post-Anesthesia Care Unit and at 24 hours post-procedure)
- Incidence of Dizziness/Vertigo(Assessed in the Post-Anesthesia Care Unit and at 24 hours post-procedure)
- Satisfaction Scores(Assessed once at the time of discharge from the Post-Anesthesia Care Unit (PACU), which occurs approximately 30 to 90 minutes after the end of the procedure.)
研究者
Wenjing Chen
Principal investigator
Children's Hospital of Hebei Province