The Median Effective Dose of Midazolam Oral Solution for Preoperative Hypnosis in Non-Elderly Adults in the Preoperative Room: An Up-and-Down Sequential Allocation Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- The Median Effective Dose (ED50) of Midazolam Oral Solution
研究概览
简要总结
Due to sleep deficiency, patients with insomnia syndrome or sub-clinical insomnia syndrome often undergo severe stress while waiting for surgery. Studies have reported that preoperative hypnosis could reduce stress and promote recovery. Midazolam has been recommended to patients who under severe stress for preoperative sedation and anti-anxiety. However, midazolam for preoperative hypnosis monitored with polysomnography (PSG) has not been studied. In this exploratory study, the median effective dose (ED50) and ED95 of Midazolam Oral Solution for preoperative hypnosis in non-elderly adults using the gold standard tool of PSG, will be explored by up-and-down sequential allocation and probit method.
详细描述
The exploratory study of ED50 will be manipulated by an up-and-down sequential allocation with a single arm prospectively.
- The day before surgery, subjects will be enrolled according to the inclusion criteria and sign the informed consent voluntarily.
- On the day of surgery, the clinical process is as follows. According to the routine medical procedures of our center, patients should access in the operating room about 2 hours before their surgery for adequate preparation.After peripheral venous catheterization, monitored by electrocardiogram, noninvasive blood pressure, and pulse oxygen saturation, invasive procedures,such as arterial catheterization, central venous catheterization or nerve blocks, will be operated individually according to surgical and anesthesia necessity.
- The intervention of Midazolam Oral Solution for preoperative hypnosis will be done after invasive procedures. The ED50 dose of midazolam oral solution for hypnosis is studied using an up-and-down sequential allocation while waiting for surgery and general anesthesia in preoperative room.
The starting dose is 6 mg and the step size is 1 mg. The interval sequential dose is varied by 1 mg based on the hypnosis response of the previous patient after one hour. Sleep of the subjects will be monitored by portable PSG (Alice PDx).
Definition of successful hypnosis by taking midazolam oral solution: The polysomnograph (PSG) not only shows stage N2 within 30 minutes, but also shows stage N3 within an hour; or else, definition of unsuccessful hypnosis. The intervention procedure : (1) The first subject takes 6mg of midazolam oral solution; (2) If succeed, the second subject will take 5mg; (3) If not succeed, the second subject will take 7mg; (4) Until seven sequence reversal inflection points. 4. Measures of safety assurance:
(1)Monitoring: Electrocardiogram, blood pressure, pulse oxygen saturation, respiratory rate, consciousness; (2)Monitors, negative pressure suction devices, oxygen inhalation devices, ventilators, items needed for emergency airway establishment, first aid medications, systemically trained anesthesiologists and nurses; (3)Emergencies include, but are not limited to: vomiting, respiratory depression, and respiratory obstruction. If any of the above events occur after intervention, the clinical procedures or emergency procedures will be followed immediately.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Signed of informed consent voluntarily;
- •Native Chinese speaker;
- •Age 18-60 years old, male or female;
- •BMI 18-30 kg/m2;
- •American Society of Anesthesiologists (ASA) grade 1 or 2, New York Heart Association (NYHA) gradeⅠorⅡ;
- •Non-emergency cancer resection surgery is planned in the next day;
- •Insomnia syndrome or sub-clinical insomnia syndrome in the past 1 month.
排除标准
- •Contraindications for Midazolam Oral Solution (According to the Instruction for Midazolam Oral Solution);
- •High risk of Obstructive Sleep Apnea Symptoms (Total score of STOP-Bang scale ≥3 points);
- •Suspected dementia (Total score of Mini-Mental State Examination (MMSE) according to years of education: 0 year≤19 points; 1~6 years≤22 points; above of 6 years≤26 points);
- •Severe depressive symptom within two weeks (Total score of Patient Health Questionnaire-9 (PHQ-9)≥15);
- •History of Neurological and Psychiatric diseases (According to the electronic medical record system);
- •History of Chronic Obstructive Pulmonary Disease (According to the electronic medical record system);
- •History of Heart Failure (According to the electronic medical record system);
- •Intestinal obstruction(The electronic medical record system records those who currently have any type of intestinal obstruction);
- •Liver and renal insufficiency;
- •Have taken opioids or drugs that act on the central nervous system within one week;
- •Take CYP3A4 isoenzyme inhibitors or inducers within one week (According to the Instruction for Midazolam Oral Solution);
- •Consume any alcoholic beverage within 24 hours;
- •Substance abusers (including alcohol, drugs or addictive substances);
- •Pregnant or lactating women;
研究组 & 干预措施
An Up-and-Down Sequential Allocation
An Up-and-Down Sequential Allocation is that the dose is varied based on the hypnosis response of the previous patient after taking midazolam oral solution for 1 hour.
干预措施: Midazolam oral solution (Drug)
结局指标
主要结局
The Median Effective Dose (ED50) of Midazolam Oral Solution
时间窗: Within 1 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room
The Median Effective Dose (ED50) of Midazolam Oral Solution for Preoperative Hypnosis in Non-Elderly Adults in the Preoperative Room, using an up-and-down sequential allocation.
次要结局
- ED95 of Midazolam Oral Solution for Preoperative Hypnosis in Non-Elderly Adults in the Preoperative Room(Within 1 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room)
- Description of Proportions of stage N1 in different doses(Within 1.5 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room)
- Description of Proportions of stage N2 in different doses(Within 1.5 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room)
- Description of Proportions of stage N3 in different doses(Within 1.5 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room)
- Description of Proportions of stage REM in different doses(Within 1.5 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room)
- Description of Sleep latency(min) in different doses(Within 1 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room)
- Description of anti-anxiety effects in different doses(Within 1.5 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room)
- Description of sedative effect in different doses(Within 1.5 hour after taking Midazolam Oral Solution while waiting for surgery in the operating room)
- Description of satisfaction for preoperative hypnosis in different doses(On postoperative day 1)
研究者
SanQing Jin
professor
Sixth Affiliated Hospital, Sun Yat-sen University