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临床试验/NCT04235894
NCT04235894已完成不适用

An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia

Osijek University Hospital0 个研究点目标入组 124 人开始时间: 2016年9月7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
发起方
入组人数
124
主要终点
Observer rating score after the procedure

研究概览

简要总结

This study investigates correlation between dreaming in propofol anesthesia and an Observer-rating-scale of facial expression after gastrointestinal endoscopy in adults. It also compares dreamers and non-dreamers in age, BMI, propofol dose, duration of procedure, mean arterial pressure, pulse values and Bispectral index values.

详细描述

After Ethical committee approval and written informed consent was obtained, a total of 124 patients undergoing gastrointestinal endoscopy were recruited in the prospective observational study. Anesthesia was maintained using incremental propofol doses until the patient was calm and unresponsive to painful stimuli. Bispectral Index (BIS), blood pressure (BP) and pulse were monitored in typical intervals: before induction, during induction, at the beginning of the procedure, at 2nd, 5th and 10th minute of the procedure, and on emergence. On the emergence of anesthesia, the patient's facial expression was rated numerically (-3 pain, +3 smile). Thereafter patients were asked to rate their dream.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consecutive patients undergoing gastrointestinal endoscopy at Osijek University HOspital form September 2016 to October 2017.

排除标准

  • . Patients who were younger than 18 years, unscheduled patients who were not hemodynamically stable, those who were not able to understand study protocol, and who did not sign written informed consent were not included in the study. Patients whose procedure was longer than 60 minutes and patients with incomplete records were excluded from the study.

研究组 & 干预措施

Patients undergoing GI endoscopy at Osijek University Hospital

Observational study. A total of 130 consecutive patients undergoing gastrointestinal endoscopy were included. The anesthesia was provided with propofol, starting with 0,5 mg/kg, and titrated until a patient was unresponsive to painful stimuli and maintaining spontaneous breathing. The blood pressure, pulse and Bispectral index values were measured in 6 defined points. On the emergence from anesthesia, the patient's facial expression was rated numerically by the investigator.

干预措施: Propofol (Drug)

结局指标

主要结局

Observer rating score after the procedure

时间窗: On the emergence of anesthesia, max. 2 hours after start of anesthesia

On the emergence of anesthesia, Observer's: rating of facial expression was written (-3: loud expression of pain; -2: painful grimace; -1: dissatisfaction; 0: neutral; 1: satisfaction; 2: smile and 3: laughter)

次要结局

  • Bispectral index values during the procedure(During the propofol anesthesia, max. 2 hours after start of anesthesia)
  • Blood pressure values during the procedure(During the propofol anesthesia, max. 2 hours after start of anesthesia)
  • Pulse values during the procedure(During the propofol anesthesia, max. 2 hours after start of anesthesia)

研究者

发起方
Osijek University Hospital
申办方类型
Other
责任方
Sponsor

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