Safety and Efficacy Evaluation of Remimazolam for Endoscopic Ultrasound-guided Fine Needle Aspiration/Biopsy
试验速览
- 阶段
- 不适用
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Cardiopulmonary adverse event incidence
研究概览
简要总结
This study aims to compare the safety and efficacy of remimazolam and propofol in EUS-FNA/FNB sedation. This study is a prospective, single-blind study. We plan to enroll 264 patients undergoing EUS-FNA and divide them into two groups. The experimental group was sedated with remimazolam, and the control group was sedated with propofol; safety and efficacy parameters such as intraoperative blood pressure, finger pulse oxygen, heart rate and sedation success rate would be compared. We hypothesized that patients in the experimental group would be superior in terms of safety parameters; the two would be equal in terms of sedation success.
详细描述
Endoscopic ultrasonography-guided fine needle aspiration/biopsy (EUS-FNA/FNB) is an important basis for the diagnosis of lesions in the upper gastrointestinal tract and adjacent organs, and plays an important role in the diagnosis of gastrointestinal tumors. Sedation is the key to a successful EUS-FNA/FNB procedure. However, intraoperative sedation in EUS-FNA/FNB is difficult and challenging. First, EUS-FNA/FNB requires a relatively long operation time and is prone to sedation-related adverse events, such as cardiovascular and cerebrovascular accidents. Second, EUS-FNA/FNB requires weakened gastrointestinal motility, thus deeper sedation is required during the operation; thirdly, the ultrasound probe used in EUS-FNA/FNB surgery is thicker than that of ordinary gastroscopes, which requires better cooperation from the patient. Therefore, the rational use of anesthesia drugs during surgery is required to ensure safety.
In current clinical studies, propofol is mostly used for anesthesia in patients undergoing EUS-FNA/FNB. In recent years, the defects of propofol for EUS sedation have gradually emerged, and its respiratory and circulatory inhibition effects have gradually caused researchers to worry. At present, propofol is still a commonly used EUS sedative drug, but with the improvement of people's requirements for sedation quality, its safety gradually cannot meet the demand. Therefore, it is the general trend to explore new EUS-FNA intraoperative sedation schemes.
Remimazolam is one of the new alternative drugs. Remimazolam is a new type of short-acting sedative-hypnotic drug, which has little inhibition on the respiratory system, less impact on hemodynamics, rapid onset of action, short half-life, rapid recovery, and no accumulation after long-term infusion. Thus, remimazolam is an effective drug for induction and maintenance of general anesthesia.
This study aims to compare the safety and efficacy of remimazolam and propofol in EUS-FNA/FNB sedation. This study is a prospective, single-blind interventional study. We plan to enroll 264 patients undergoing EUS-FNA and divide them into two groups. The experimental group was sedated with remimazolam, and the control group was sedated with propofol; safety and efficacy parameters such as intraoperative blood pressure, finger pulse oxygen, heart rate and sedation success rate would be compared. We hypothesized that patients in the experimental group would be superior in terms of safety parameters; the two would be equal in terms of sedation success.
This study is divided into the following steps:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Care provider(anesthesiologist) cannot be blinded for different appearance of propofol and remimazolam.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥18 years old and ≤75 years old
- •BMI: 18kg/m^2<BMI<30kg/m^2;
- •Body weight: 40kg<weight<120kg
- •Patients who intend and qualified to undergo sedated EUS-FNA/FNB.
- •Clearly understand, voluntarily participate in the research, and sign the informed consent form.
排除标准
- •Patients who are not suitable for sedated EUS-FNA/FNB for any reason (e.g. cardiovascular disease)
- •Patients have abnormal liver function, AST and/or ALT≥2.5×ULN, TBIL≥1.5×ULN;
- •Patients have abnormal renal function, urea or blood urea nitrogen≥1.5×ULN, serum creatinine≥1.0 ×ULN
- •Those who are allergic to benzodiazepines, opioids, propofol or lidocaine.
- •Patients have contraindications for benzodiazepines, opioids, propofol or lidocaine.
- •Patients have benzodiazepines, opioids, propofol, lidocaine suspected narcotic drug abuse history and pain drug or sedative abuse.
- •Patients have history of drug use and/or alcoholism within 2 years before the start of the period. Alcoholism means drinking more than 2 units of alcohol on average per day (1 unit = 360 mL of beer or 45 mL of liquor with an alcohol content of 40% or 150 mL of wine)
研究组 & 干预措施
Remimazolam group
- Background oxycodone injection: Slowly inject oxycodone(0.05mg/kg) intravenously. Three minutes (± 1min) after the end of oxycodone injection , begin sedation induction as follows.
- Sedation induction before EUS-FNA/FNB: the initial dose of remimazolam is 0.15-0.2 mg/kg, and the intravenous injection time is about 1 minute. If the subject's MOAA/S score is 1 point or below after the initial dose, EUS-FNA/FNB can be started; if the degree of sedation is insufficient, additional remimazolam(0.05 mg/kg each time) is allowed. The injection time of additional remimazolam is not less than 15 seconds, and the time interval between each additional administration is ≥ 2 minutes.
- Maintenance of sedation: In order to maintain the MOAA/S≤1, the investigator can decide to add remimazolam 0.05mg/kg each time, and the intravenous injection time should not be less than 15 seconds, with an additional administration interval of ≥ 2 minutes.
干预措施: Remimazolam Injection (Drug)
Propofol group
- Background oxycodone injection: Slowly inject oxycodone(0.05mg/kg) intravenously. Three minutes (± 1min) after the end of oxycodone injection , begin sedation induction as follows.
- Sedation induction before EUS-FNA/FNB: the initial dose of propofol is 1.5-2.0 mg/kg, and the intravenous injection time is about 1 minute. If the subject's MOAA/S score is 1 point or below after the initial dose, EUS-FNA/FNB can be started; if the degree of sedation is insufficient, additional propofol(0.5 mg/kg each time) is allowed. The injection time of additional propofol is not less than 15 seconds, and the time interval between each additional administration is ≥ 2 minutes.
- Maintenance of sedation: In order to maintain the MOAA/S≤1, the investigator can decide to add propofol 0.5mg/kg each time, and the intravenous injection time should not be less than 15 seconds, with an additional administration interval of ≥ 2 minutes.
干预措施: Propofol Injection (Drug)
结局指标
主要结局
Cardiopulmonary adverse event incidence
时间窗: The whole EUS-FNA/FNB procedure
The occurrence of any one of the following reactions was recorded as "Cardiopulmonary Adverse Event", and the cardiopulmonary adverse event incidence was defined as the proportion of the subjects with cardiopulmonary adverse events in each group. Cardiopulmonary adverse events were defined as: any of the following conditions occurred during the operation: 1. respiratory depression: oxygen saturation \<90%, or breathing \<8 times/min; 2. apnea: respiratory airflow stopped for more than 15s; 3. hypotension: systolic blood pressure decrease greater than 20% of baseline systolic blood pressure; 4. hypertension: systolic blood pressure increase greater than 20% of baseline systolic blood pressure; 5. tachycardia: heart rate\>100bpm for 1 minute or more; 6. bradycardia: HR\<50, lasting 1 minute or more
次要结局
- Adverse event incidence(The whole EUS-FNA/FNB procedure)
- Sedation success rate:(The whole EUS-FNA/FNB procedure)
研究者
wang xiaoyan
Doctor
The Third Xiangya Hospital of Central South University