跳至主要内容
临床试验/NCT05357872
NCT05357872Unknown不适用

Dreaming During Anesthesia and Anesthetic Depth in Elective Surgery Patients Under General Anesthesia

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Total dose of propofol

研究概览

简要总结

Dreaming is a common, enduring, and fascinating part of the anesthetic experience, but its cause and timing remain elusive. Patients typically report that they were dreaming during anesthesia, but the actual timing of anesthetic dreaming is unknown. The following evidence supports the hypothesis that dreaming occurs intraoperatively and is related to light or inadequate anesthesia: (1) The incidence of dreaming has decreased as anesthetic techniques have improved; (2) dreamers exhibit more clinical signs of light anesthesia or report more awareness than non dreamers; (3) dreamers may receive lower doses of anesthetic drugs than non dreamers and emerge more rapidly from anesthesia; (4) the content of dreams may involve surgical topics or events occurring during anesthesia; and (5) in one study, the incidence of dreaming was lower in Bispectral Index (BIS)-monitored patients. Alternatively, dreaming may occur during emergence from anesthesia, when the brain is still affected by sedative concentrations of anesthetic drugs and the patient enters a sleep state. Few studies have assessed the relation between dreaming and depth of anesthesia, and their results were inconclusive.Most recently, in the B-Aware Trial, no differences in depth of anesthesia, as measured by BIS, were detected between dreamers and non dreamers. However, the patients were at high risk of awareness, and BIS data were collected manually and were only recorded in the BIS group and during maintenance. No studies investigating the relation between dreaming and depth of anesthesia during recovery were identified. Why is the investigation of dreaming during anesthesia important? Dreaming is one of the most common side effects of anesthesia but remains puzzling and requires explanation. Dreaming is sometimes distressing to patients and may decrease satisfaction with care. Some patients who report dreaming fear that their anesthetic was inadequate and that their experience was, in fact, awareness. Indeed, in a minority of cases, dreaming may truly represent near-miss awareness. The investigators therefore tested the hypothesis that dreaming during anesthesia is associated with light or inadequate anesthesia, as evidenced by higher median BIS values during maintenance of anesthesia. The investigators also explored the depth of anesthesia until emergence, the form and content of dreams, the predictors of dreaming during anesthesia, and the effect of dreaming on quality of recovery and satisfaction with anesthetic care

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
否

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

BIS 40-50 Group

Experimental

The anesthesiologist adjusted the intravenous speed of remifentanil and propofol to maintain the bispectral index (BIS, BIS monitor; Aspect Medical System, Newton, MA) between 40-50

干预措施: deep anesthesia depth (Device)

BIS 50-60 Group

Experimental

The anesthesiologist adjusted the intravenous speed of remifentanil and propofol to maintain the bispectral index (BIS, BIS monitor; Aspect Medical System, Newton, MA) between 50-60 during the operation.

干预措施: light anesthesia depth (Device)

结局指标

主要结局

Total dose of propofol

时间窗: at the end of surgery

record total dose of propofol

Mean blood pressure

时间窗: the time when leaving the operation room

record mean blood pressure during the surgery. Systolic, diastolic, or both pressures don't need to be assessed during the study period.

heart rate

时间窗: the time when leaving the operation room

record heart rate during the surgery

Bispectral Index (BIS)

时间窗: the time when leaving the operation room

record BIS during the surgery. record BIS during the surgery. The range was 0-100. We control the range of BIS in 40-60 during the surgery

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)

Mean blood pressure

时间窗: 5 minutes after entering the operation room

record mean blood pressure during the surgery. Systolic, diastolic, or both pressures don't need to be assessed during the study period.

Mean blood pressure

时间窗: procedure (anesthesia induction)

record mean blood pressure during the surgery. Systolic, diastolic, or both pressures don't need to be assessed during the study period.

Mean blood pressure

时间窗: at the end of surgery

record mean blood pressure during the surgery. Systolic, diastolic, or both pressures don't need to be assessed during the study period.

Mean blood pressure

时间窗: procedure (anesthesia extubation)

record mean blood pressure during the surgery. Systolic, diastolic, or both pressures don't need to be assessed during the study period.

heart rate

时间窗: 5 minutes after entering the operation room

record heart rate during the surgery

heart rate

时间窗: procedure (Anesthesia induction)

record heart rate during the surgery

heart rate

时间窗: at the end of surgery

record heart rate during the surgery

heart rate

时间窗: procedure (anesthesia extubation)

record heart rate during the surgery

Bispectral Index (BIS)

时间窗: 5 minutes after entering the operation room

record BIS during the surgery. The range was 0-100. We control the range of BIS in 40-60 during the surgery

Bispectral Index (BIS)

时间窗: procedure (Anesthesia induction)

record BIS during the surgery. record BIS during the surgery. The range was 0-100. We control the range of BIS in 40-60 during the surgery

Bispectral Index (BIS)

时间窗: at the end of surgery

record BIS during the surgery. record BIS during the surgery. The range was 0-100. We control the range of BIS in 40-60 during the surgery

Bispectral Index (BIS)

时间窗: procedure (anesthesia extubation)

record BIS during the surgery. record BIS during the surgery. The range was 0-100. We control the range of BIS in 40-60 during the surgery

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)

Loading locations...

相似试验