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临床试验/NCT06609538
NCT06609538已完成不适用

"The Impact of Preoperative Suggestions on Dreaming With Intravenous Sedation: A Randomized Controlled, Blinded Trial."

Wonkwang University Hospital2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年9月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
2
主要终点
Incidence of Dreaming

研究概览

简要总结

Recent studies have shown that positive preoperative suggestions can significantly influence the quality of dreams and reduce the incidence of unpleasant dreams during sedation with agents like ketamine and propofol.

详细描述

Cheong et al. demonstrated that a simple positive suggestion before ketamine administration could reduce unpleasant dreams, while Kim et al. found that propofol, compared to midazolam, led to more vivid and memorable dreams, along with similar satisfaction levels in patients. This study aims to extend these findings by comparing the effects of propofol and ketamine sedation on dreaming during anesthesia, with a focus on how preoperative suggestions might influence dream content, emotional tone, and patient satisfaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged 20-65 years.
  • ASA physical status I-III.
  • Scheduled for elective spinal anesthesia or brachial plexus block.
  • Fluent in Korean.

排除标准

  • Use of any medication, including premedication, within 12 hours before surgery.
  • Cognitive impairments or psychiatric disorders (including a history of unpleasant dreams or nightmares).
  • Current use of sedatives or hypnotics.
  • History of severe or recurrent nightmares.

结局指标

主要结局

Incidence of Dreaming

时间窗: Dreaming will be assessed immediately after full awakeness in the Post-Anesthesia Care Unit (PACU).

The "Dreaming and Cognition Evaluation Questionnaire" will be used.questionnaire evaluates the incidence of dreaming, as well as the dream's content, emotional tone (rated on a 1-5 scale from very unpleasant to very pleasant), memorability, visual vividness, intensity, and other qualitative aspects such as sound, movement, and emotional significance.

Quality of Dreaming

时间窗: Dreaming will be assessed immediately in the Post-Anesthesia Care Unit (PACU).

The "Dreaming and Cognition Evaluation Questionnaire" will be used. This questionnaire evaluates the incidence of dreaming, as well as the dream's content, emotional tone (rated on a 1-5 scale from very unpleasant to very pleasant), memorability, visual vividness, intensity, and other qualitative aspects such as sound, movement, and emotional significance.

次要结局

  • Satisfaction with Care(Satisfaction will be assessed immediately after full awakeness in the Post-Anesthesia Care Unit (PACU))
  • Adverse events(Monitoring will be continuous with regular vital signs recorded every 5 minutes during surgery and every 15 minutes in the PACU.)

研究者

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

Cheol Lee,MD,PhD,

Professor, M.D., Ph.D

Wonkwang University Hospital

研究点 (2)

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