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Propofol-related Euphoria in Pain-free Gastrointestinal Endoscopy Patients

N

Northern Jiangsu People's Hospital

Status

Completed

Conditions

Propofol
Addictive Behaviors

Study type

Observational

Funder types

Other

Identifiers

NCT06602297
2024ky248

Details and patient eligibility

About

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

Enrollment

986 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial contacts and locations

1

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Central trial contact

Ju GAO; Mingzhu Meng

Data sourced from clinicaltrials.gov

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