Propofol-related Euphoria in Pain-free Gastrointestinal Endoscopy Patients
China986 participantsStarted 2024-09-18
Plain-language summary
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
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
What they're measuring
1
Incidence of propofol-related euphoria
Timeframe: preoperatively , within half an hour after the operation, postoperative days 1 ,3 and 7
2
Severity of propofol-related euphoria
Timeframe: preoperatively , within half an hour after the operation, postoperative days 1,3 and 7
3
Duration of propofol-related euphoria
Timeframe: within half an hour after the operation, postoperative days 1 ,3 and 7