A Prospective, Single-center, Cross-sectional Clinical Investigation of Propofol-related Euphoria in Pain-free Gastrointestinal Endoscopy Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 986
- 试验地点
- 1
- 主要终点
- Incidence of propofol-related euphoria
研究概览
简要总结
To define the prevalence, duration and severity of propofol-associated euphoria in patients undergoing painless gastrointestinal endoscopy and to explore the independent influencing factors by means of a single-center, cross-sectional clinical research study
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Proposed to perform painless GI endoscopy, and simple endoscopic maneuvers such as single small polyp clamping, performing HP examination, etc;
- •Gender is not limited;
- •18 years old ≤ 80 years old;
- •ASA classification: I-II;
- •18 kg/m2 <BMI <30 kg/m2;
- •Informed consent, voluntary participation in the trial, and informed consent signed by the subjects themselves.
排除标准
- •adjudicated respiratory management difficulties;
- •History of substance abuse as well as drug use;
- •Participation in a clinical trial of another drug or device within 3 months prior to the screening period
- •Use of therapeutic drugs (e.g., benzodiazepines, opioid analgesics) by the subject within 3 months prior to the Screening Period for a variety of reasons (e.g., insomnia, pain, etc.) that may have an impact on the outcome of the trial, etc;
- •Allergy or contraindication to the study drug or components thereof;
- •Previous psychiatric or neurological disorders (e.g., schizophrenia, mania, bipolar disorder, psychosis, epilepsy, neuralgia, etc.) and a history of taking medications corresponding to the treatment of the corresponding psychiatric or neurological disorders (e.g., antidepressants, anxiolytics, convulsants, antiepileptic drugs, etc.);
- •Pregnant women;
- •Subjects with severe communication disorders due to severe hearing deterioration;
- •Refusal to participate in this study;
- •Those deemed unsuitable by the investigator.
结局指标
主要结局
Incidence of propofol-related euphoria
时间窗: preoperatively , within half an hour after the operation, postoperative days 1 ,3 and 7
Subjects were asked in person or through telephone follow-up, "To what extent do you think you are feeling pleasure and euphoria now?". The NRS is a numerical rating scale (NRS) that represents feelings of euphoria on a scale of 0-10, with 0 being no feelings of euphoria at all and 10 being the strongest feelings of euphoria.
Severity of propofol-related euphoria
时间窗: preoperatively , within half an hour after the operation, postoperative days 1,3 and 7
Subjects were asked in person or via telephone follow-up, "Has your pleasant, euphoric mood changed now compared to before surgery?" , using the Likert questionnaire score (5-Point Likert Scale, Likert): 0 indicates that the mood is significantly worse than before; 1 indicates that the mood is mildly worse than before; 2 indicates that there is no change in euphoria; 3 indicates that there is a mild euphoria; and 4 indicates that there is a markedly euphoric mood.
Duration of propofol-related euphoria
时间窗: within half an hour after the operation, postoperative days 1 ,3 and 7
Postoperatively, subjects were asked about changes in mood compared to baseline values by the same method, and their duration was confirmed.
次要结局
- Anxiety level(preoperatively , within half an hour after the operation, postoperative days 1,3 and 7)
- Subject satisfaction with the quality of perioperative anesthesia(at postoperative days 1 after the subject had recovered from all adverse events, if the subject did not have a perioperative adverse event)
- Content of Memory of Intraoperative Dreams(Within half an hour after the operation)
- The number of times of sleep in the 72h postoperative period(Postoperative days 1 and 3)
- the duration of each sleep in the 72h postoperative period(Postoperative days 1 and 3)
- the quality of sleep each time in the 72h postoperative period(Postoperative days 1 and 3)
- Perioperative adverse events(Within half an hour after the operation, postoperative days 1,3 and 7. If the adverse events had not disappeared by T7d, telephone follow-up was conducted every 3d thereafter until the adverse events were resolved.)
研究者
Ju Gao
Study Director
Northern Jiangsu People's Hospital