A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Hemodynamic Stability - Mean Arterial Pressure (MAP)
研究概览
简要总结
The goal of this prospective, randomized, controlled study is to compare remimazolam besilat/sufentanyl and propofol/sufentanyl in patients during colonoscopic polypectomies procedures.
Patients undergoing colonoscopic polypectomies in procedural sedation using remimazolam besylate/sufentanyl are circulatory and respiratory as or more stable when compared with propofol/sufentanyl sedation.
详细描述
Following the approval for the research by the Ethics Committee (Clinical Hospital Center, Zagreb, Croatia), a total of ninety (90) patients will be included in the research. Forty five (45) patients will be assigned to the study group (SG) and forty five (45) patients to the control group (CG).
Research Goals:
Primary goals
- Observe and compare circulatory and respiratory stability in patients undergoing procedural sedation with either remimazolam besylate or propofol during colonoscopic polypectomies
- Define and compare the incidence of hypotension between the study grou and the control group.
- Define and compare the incidence of respiratory depression between the study group and the control group.
Secondary goals
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 (Participant)
盲法说明
Considering that this is a single blind study, neither the controlled group nor the study group will be aware of which medication they are given because the method of administration is the same (therapeutic gold standard). The only individual who will know which medication is administered will be the primary researcher/anesthesiologist who will be administering the medication themselves.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients both male and female
- •ages 18 to 60 years,
- •with one or more colonic polyps confirmed by colonoscopy and scheduled for a colonoscopy and polypectomy
- •The duration of the colonoscopy ranges from 30 to 50 minutes.
- •ASA status (American Society of Anaesthesiologists physical status) I-III.
- •BMI (Body mass index) 18.5-29.9 kg/m
- •Only patients who signed an informed consent waiver and consented to participate in the research study.
排除标准
- •Patients aged >60 years
- •ASA status IV-V,
- •BMI >29.9 kg/m2,
- •a high risk of vomiting, regurgitation and/or aspiration of gastric contents.
- •Patients with:
- •uncontrolled hypertension (systolic pressure >160 mmHg),
- •heart disease (cardiomyopathy, cardiac-rhythm disorder, left ventricular ejection fraction <45%, stenosis or heart valve insufficiency and coronary heart disease)
- •lung disease (pneumonia, chronic obstructive pulmonary disease, asthma and pulmonary tumors),
- •kidney diseases (kidney failure, GF 30/59 ml/min/1.73m2),
- •liver diseases,
- •coagulation disorders
- •lymphatic tissue diseases
- •extended malignant disease.
- •History of allergy on nutritional allergens including soy bean, benzodiazepines, propofol or opioids.
- •Patients who currently use analgesic medications or other psycho-pharmaceuticals.
- •History of illicit drug use.
- •Children, pregnant and nursing women.
- •Alcohol dependency.
- •Patients involved in other clinical research studies,
- •patients who refused to take part in the research or have not signed the written informed consent form.
研究组 & 干预措施
Remimazolam besylat
干预措施: Remimazolam besylate (Drug)
Propofol
干预措施: Propofol (Drug)
结局指标
主要结局
Hemodynamic Stability - Mean Arterial Pressure (MAP)
时间窗: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.
Mean arterial pressure (mmHg) measured at multiple timepoints to assess overall circulatory stability. Comparison of MAP values between remimazolam and propofol groups.
Hemodynamic Stability - Systolic and Diastolic Blood Pressure
时间窗: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.
Systolic and diastolic blood pressure (mmHg) measured at multiple timepoints to assess circulatory stability. Comparison between remimazolam and propofol groups.
Hemodynamic Stability - Heart Rate
时间窗: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.
Heart rate (beats per minute) measured continuously via ECG monitoring. Comparison of heart rate values between study groups.
Incidence of Hypotension
时间窗: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.
Percentage of participants experiencing hypotension defined as either: Decrease in systolic blood pressure ≥20% from baseline value (measured before remimazolam or propofol administration), OR Mean arterial pressure (MAP) ≤60 mmHg during procedural sedation
Incidence of Bradycardia
时间窗: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.
Bradycardia is defined as a heart rate (HR) below 50 beats per minute (bpm), or a clinically significant decrease in HR of ≥20% from the pre-induction baseline, sustained for ≥1 minute and/or requiring pharmacological or non-pharmacological intervention (e.g., atropine administration, reduction or discontinuation of the study drug). HR will be continuously monitored via standard intraoperative ECG monitoring and recorded at predefined time points: baseline (pre-induction), immediately post-induction (T1), at 5-minute intervals intraoperatively, at emergence from anesthesia, and at 15 and 30 minutes postoperatively in the post-anesthesia care unit (PACU). The incidence of bradycardia will be expressed as the proportion of patients experiencing at least one episode meeting the above criteria within the defined observation window.
Respiratory Stability - Oxygen Saturation (SpO₂)
时间窗: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.
Peripheral oxygen saturation (%) measured continuously via pulse oximetry. Comparison of SpO₂ values between study groups.
Incidence of Respiratory Depression
时间窗: from enrollment up to 2 hours after the procedure; approximately 2-4 hours per participant.
Percentage of participants experiencing respiratory depression defined as: Respiratory rate \<8 breaths per minute, AND/OR Peripheral oxygen saturation (SpO₂) \<90%
次要结局
- Procedural Sedation Success Rate(During the endoscopic procedure (estimated 30-50 minutes)
- Time to Adequate Sedation Level(From first drug administration until adequate sedation achieved (estimated 1-5 minutes))
- Time to Full Alertness(From last drug administration until full alertness (estimated 10-20 minutes post-procedure))
- Time to Recovery Room Discharge Readiness(From last drug administration until meeting discharge criteria (estimated 15-30 minutes post-procedure))
- Depth of Sedation - BIS Values(From baseline through procedure completion until full alertness (estimated 30-60 minutes))
- Depth of Sedation - MOAA/S Scores(Baseline, immediately after drug administration, then every 30 seconds for 3 minutes, then as clinically indicated during procedure)
- Total Drug Dosage(During procedure (estimated 30-50 minutes))
- Procedure and sedation duration(From first drug administration to full alertness (estimated 30-60 minutes) From procedure start to procedure completion (estimated 30-50 minutes))
- Total Crystalloid Infusion Volume(During procedure and recovery (estimated 30-90 minutes))
- Incidence of Post-Procedure Pain, nausea and vomiting(ost-procedure assessment before recovery room discharge (estimated 30-60 minutes after last drug dose))
- Satisfaction Score(Post-procedure before recovery room discharge)
研究者
Željko Drvar
Principal invesitgator
Clinical Hospital Centre Zagreb