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临床试验/NCT05173688
NCT05173688已完成不适用

The Relationship Between Different Doses of Propofol and the Occurrence of Dreams in Short Surgery Under General Anesthesia

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年11月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Mean blood pressure (systolic and diastolic)

研究概览

简要总结

Dreams are a remarkable experiment in psychology and neuroscience, conducted every night in every sleeping person. 74% of awakenings from REM sleep resulted in recall of a dream, as compared with only 9% of awakenings from NREM sleep. The association between dreaming and REM sleep was subsequently replicated by many other investigators; typically, around 80% of REM awakenings yield dreams. It became clear over time that there is a good deal of mental activity that occurs during NREM sleep. Typically, it is more thought like, fragmentary, and related to daily concerns than the vivid, hallucinatory, predominantly visual narratives that are most commonly reported from REM sleep. But even this distinction appears not to be absolute. There is now wide acceptance of the view that some dreaming that is indistinguishable from REM sleep dreaming occurs in NREM sleep, most frequently in the sleep-onset period. General anesthesia causes a drug-induced state of unconsciousness and is a non-physiological process that is similar to natural sleep. Patients receiving propofol for maintenance of general anesthesia often report higher incidences of dreaming than patients maintained with volatile anesthetics. One explanation is that propofol and volatile anesthetic have different pharmacological effects in the central nervous system. An alternative explanation is that propofol is associated with more rapid emergence from anesthesia than the older volatile anesthetics, allowing patients to report their dreams before they are forgotten. In order to further verify the hypothesis, the investigators choose gynecological general anesthesia to observe whether the generation of dreams is related to the dose of general anesthesia maintenance .

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • between 18 and 70 years
  • with an ASA physical status of I or II

排除标准

  • presence of sleep disorders
  • pain syndrome
  • cardiovascular disease
  • sleep apnea syndrome
  • psychosis
  • history of opioid usage
  • history of abnormal operation or anesthesia recovery
  • unwillingness to provide informed consent
  • a patient with a language communication disorder

研究组 & 干预措施

Low maintenance dose propofol group

Experimental

The low maintenance dose propofol group was maintained at 4-6 mg/kg/h

干预措施: Propofol (Drug)

High maintenance dose propofol group

Experimental

The high maintenance dose propofol group was maintained at 8-12 mg/kg/h

干预措施: Propofol (Drug)

结局指标

主要结局

Mean blood pressure (systolic and diastolic)

时间窗: leaving the operation room

record mean blood pressure during the surgery

heart rate

时间窗: leaving the operation room

record heart rate during the surgery

BIS

时间窗: leaving the operation room

record BIS during the surgery

Total dose of propofol

时间窗: at the end of surgery

record total dose of propofol

Dream

时间窗: at the end of surgery

Dreaming during anesthesia was defined as any experience that was described by the patient as dreaming and was thought by the patient to have occurred between the induction of anesthesia and the first moment of consciousness after anesthesia.27 Awareness was defined as postoperative recall of intraoperative events. All patients who reported dreaming were considered to be "dreamers" for the purpose of the analyses, whether or not they could remember the narrative of the dream. However, only dreaming reports where the narrative was remembered were classified using five-point Likert scales as follows. Emotional content (1 very negative; 5 very positive) ● Memorability (1 can't remember narrative of dream; 5 most memorable ever) ● Visual vividness (1 not at all vivid; 5 most vivid ever) ● Amount of sound (1 no sound; 5 most sound ever)

次要结局

  • Postoperative adverse effects(24 hours after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanchao Yang

principal investigator

Shengjing Hospital

研究点 (1)

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