Status:
COMPLETED
Propofol-related Euphoria in Pain-free Gastrointestinal Endoscopy Patients
Lead Sponsor:
Northern Jiangsu People's Hospital
Conditions:
Propofol
Addictive Behaviors
Eligibility:
All Genders
18-80 years
Brief 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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 18 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
986 Patients enrolled
Trial Details
Trial ID
NCT06602297
Start Date
September 18 2024
End Date
June 30 2025
Last Update
December 8 2025
Active Locations (1)
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1
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China, 225001