NCT07028190招募中不适用
Changes in Rimazolen Dosage in Patients With Insomnia Under Intravenous Anesthesia: a Prospective Cohort Study
Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 840 人开始时间: 2025年6月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 840
- 试验地点
- 1
- 主要终点
- The total consumption of rimazolen
研究概览
简要总结
To compare the dosage requirement of rimazolen under intravenous anesthesia between patients with insomnia and those with normal sleep pattern.
详细描述
The investigators aim to investigate whether rimazolen dosage requirement is increased in patients with insomnia under intravenous anesthesia compared with normal sleep patterns.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with insomnia:
- •Age of 18 - 64 years;
- •American Society of Anesthesiologists (ASA) physical status of I - II;
- •Body mass index (BMI) of 15 - 30;
- •Patients undergoing elective thoracoscopy, laparoscopy, hysteroscopy, open abdominal surgery, open thoracic surgery, open spinal surgery, craniotomy surgery, and digestive endoscopy under general anesthesia;
- •Positive screening results according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for insomnia disorder;
- •8-item Sleep Condition Indicator (SCI; score 0-4; range 0-32, higher score means better sleep) scored 16 or less.
- •Patients with normal sleep:
- •Age of 18 - 64 years;
- •ASA physical status of I - II;
- •BMI of 15 - 30;
- •Patients undergoing elective thoracoscopy, laparoscopy, hysteroscopy, open abdominal surgery, open thoracic surgery, open spinal surgery, craniotomy surgery, and digestive endoscopy under general anesthesia;
- •No history or evidence of insomnia.
排除标准
- •Associated with any neurological disease;
- •Daily alcohol consumption;
- •Any contraindication to intravenous anesthetic drug, such as hypotension or shock;
- •History of allergy to any drug used in the study;
- •Pregnancy or breastfeeding;
- •Patients with sleep apnea syndrome;
- •acute upper respiratory infection;
- •Patients with psychological diseases who report suicidal thoughts;
- •Patients who need to work or take care of children/elderly people frequently at night.
研究组 & 干预措施
Insomnia group
Patients with insomnia
干预措施: No interventions, it is a observational study (Other)
Normal sleep group
Patients with normal sleep
干预措施: No interventions, it is a observational study (Other)
结局指标
主要结局
The total consumption of rimazolen
时间窗: Up to 1 day
The total consumption of rimazolen for the produre. It includes the total amount of ciprofol required by the patient for the entire procedure.
次要结局
- The dosage of rimazolen for induction of anesthesia(1 day)
- The occurrence of the respiratory and cardiovascular adverse events(The day of the procedure and 24 hours after the procedure)
- The occurrence of the other adverse events(The day of the procedure and 24 hours after the procedure)
- The incidence of intraoperative recall or awareness(The day of the procedure and 24 hours after the procedure)
- The ease of operation at this level of sedation evaluated by the operation doctors(Up to 1 day)
- The satisfaction degree of anesthesia effect evaluated by the operation doctors(Up to 1 day)
- The recovery time(Up to 1 day)
- Duration of patients' PACU stay(Up to 1 day)
- Patients' satisfaction(Up to 1 day)
- Patients' willingness(Up to 1 day)
研究者
Fang Luo
Director of Department of Day surgery and Pain Management Affiliation: Beijing Tiantan Hospital
Beijing Tiantan Hospital
研究点 (1)
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