Effect of Dexmedetomidine Pretreatment on The Effective Dose of Remimazolam Tosilate Inhibiting Cardiovascular Response to Intubation of Double-Lumen Endobronchial Tubes: A Clinical Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- ED50 and ED95 of remimazolam
研究概览
简要总结
General anesthesia with double-lumen endobronchial tubes intubation is the main anesthesia method in thoracic surgery.However, double-lumen endobronchial tubes intubation can produce greater stimulation and cause more cardiovascular reactions, and the ideal anesthetic drugs can effectively reduce adverse reactions.Remimazolam is a new type of benzodiazepine drug that can be safely used for the induction and maintenance of general anesthesia, and it is an ideal and short-acting anesthetic alternative.As the new drug has had a short clinical entry time.There are few clinical data in all aspects, so it is necessary to clarify its rational use in the induction of anesthesia.Dexmedetomidine is a highly selective α 2 adrenergic receptor agonist, and it is currently the most popular adjunct to clinical anesthesia.However, the clinical data of anesthesia induction by dexmedetomidine combined with Remimazolam are rarely reported.
In the case of prior use of dexmedetomidine, to explore 50% effective dose (ED50) and ED95 of Remimazolam for the induction of anesthesia to inhibit the cardiovascular response of double-lumen bronchial intubation, in order to provide more data for the rational use of remimazolam and a reference for clinical rational drug use.
详细描述
This study is a clinical trial of adaptive design dose exploration evaluating the effect of dexmedetomidine pretreatment on the effective dose of remimazolam tosilate inhibiting cardiovascular response to intubation of double-lumen endobronchial tubes.Following the design principle, conduct dynamic exploration by sequential method, using the near ED95 drug dose for subjects according to the pretest.To determine whether the next subject increases or decreases the pre-set fixed drug dose according to the previous subject. The trial was stopped when seven exchange points occurred, at which point the total sample size was obtained.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Optional Video-Assisted Thoracoscopic Surgery (VATS)
- •More than 18 years old
- •American Association of Anesthesiologists (ASA) grade I~III
排除标准
- •Systolic pressure ≥160 mmHg or diastolic pressure ≥110 mmHg or heart rate ≥ 110 beats / min in the operating room when quietly
- •Long-term use of analgesia or sedation drugs before surgery
- •Pregnancy, lactation, pregnancy possibility and planned pregnancy
- •Allergy history of the test drug
- •Mental illness or an inability to communicate normally.
研究组 & 干预措施
Group A
Dexmedetomidine pretreatment dose was 0. The effective dose of remimazolam tosilate inhibiting cardiovascular response during double-lumen tracheal intubation in elderly patients (age > 65 years) and young patients (18 < age <65 years) was explored respectively, without the use of dexmedetomidine. The starting dose of Remimazolam tosilate for Injection (36mg per bottle, powder, HengRui medicine, China) was 0.25 mg / kg, and the adjusted unit dose was 0.01mg.
干预措施: Remimazolam tosilate (Drug)
Group B
Dexmedetomidine hydrochloride injection (200ug per bottle, HengRui medicine, China) was diluted to 50ml and the pretreatment dose was 0.5μg/kg at first 10 mins.The starting dose of Remimazolam tosilate for Injection (36mg per bottle, powder, HengRui medicine, China) was 0.15 mg / kg, and the adjusted unit dose was 0.01mg.
干预措施: Dexmedetomidine (Drug)
Group B
Dexmedetomidine hydrochloride injection (200ug per bottle, HengRui medicine, China) was diluted to 50ml and the pretreatment dose was 0.5μg/kg at first 10 mins.The starting dose of Remimazolam tosilate for Injection (36mg per bottle, powder, HengRui medicine, China) was 0.15 mg / kg, and the adjusted unit dose was 0.01mg.
干预措施: Remimazolam tosilate (Drug)
Group C
Dexmedetomidine hydrochloride injection (200ug per bottle, HengRui medicine, China) was diluted to 50ml and the pretreatment dose was 1μg/kg at first 10 mins.The starting dose of Remimazolam tosilate for Injection (36mg per bottle, powder, HengRui medicine, China) was 0.1 mg / kg, and the adjusted unit dose was 0.01mg.
干预措施: Dexmedetomidine (Drug)
Group C
Dexmedetomidine hydrochloride injection (200ug per bottle, HengRui medicine, China) was diluted to 50ml and the pretreatment dose was 1μg/kg at first 10 mins.The starting dose of Remimazolam tosilate for Injection (36mg per bottle, powder, HengRui medicine, China) was 0.1 mg / kg, and the adjusted unit dose was 0.01mg.
干预措施: Remimazolam tosilate (Drug)
结局指标
主要结局
ED50 and ED95 of remimazolam
时间窗: Through study completion, an average of 3 month.
Half of the effective doses (ED50) and 95% effective doses (ED95 ) of remimazolam to inhibit the cardiovascular response of double-lumen bronchial intubation during anesthesia induction after dexmedetomidine (DEX) pretreatment. Positive cardiovascular responses is determined when the highest hypertension or heart rate caused by bronchial intubation exceeds 15% of the baseline value. And the test will be ended with seven positive to negative transitions through sequential dose exploration. ED50 and ED 95 will be calculated by probit regression using the collected dose and cardiovascular response outcome data after study completion.
次要结局
- Success rate of sedation(Through study completion, an average of 3 month.)
- Cardiovascular response within 3 min of intubation(The evaluation time included the start of endotracheal intubation until three minutes after completion.)
- Blood Pressure(Intraoperative (Four time points. Time 1: When calm in the operating room. Time 2: At the end of dexmedetomidine pumping. Time 3: End of the remimazolam infusion. Time 4:the start of endotracheal intubation until 3 min after completion))
- Heart Rate(Intraoperative (Four time points. Time 1: When calm in the operating room. Time 2: At the end of dexmedetomidine pumping. Time 3: End of the remimazolam infusion. Time 4:the start of endotracheal intubation until 3 min after completion))
- Incidence of Hypotension(Through study completion, an average of 3 month.)
- The incidence of reduced heart rate(Through study completion, an average of 3 month.)
研究者
Shiyou Wei
Medical Master, Attending Doctor.
Shanghai Pulmonary Hospital, Shanghai, China