Exploring euphoria from propofol in patients undergoing painless gastrointestinal endoscopy

A Prospective, Single-center, Cross-sectional Clinical Investigation of Propofol-related Euphoria in Pain-free Gastrointestinal Endoscopy Patients

This study looks at how many patients feel happy or euphoric after receiving propofol during a painless gastrointestinal endoscopy and how long those feelings last.

Quick facts

• Study type: Observational
• Enrollment: 986 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Northern Jiangsu People's Hospital (Academic / other)
• Locations: 1 site (Yangzhou, Jiangsu)
• Trial ID: NCT06602297 on ClinicalTrials.gov

What this trial studies

This observational study aims to define the prevalence, duration, and severity of euphoria associated with propofol in patients undergoing painless gastrointestinal endoscopy. It will utilize a cross-sectional approach to gather data on patients who meet specific inclusion criteria. The study will also investigate independent factors that may influence the experience of euphoria during the procedure.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who are scheduled for painless gastrointestinal endoscopy and meet specific health criteria.

Not a fit: Patients with a history of substance abuse, respiratory management difficulties, or previous psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of propofol's effects, potentially improving patient comfort and satisfaction during gastrointestinal procedures.

How similar studies have performed: While studies on propofol's effects exist, this specific focus on euphoria during gastrointestinal endoscopy is relatively novel.

Eligibility criteria

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.

Where this trial is running

Yangzhou, Jiangsu

• Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Ju GAO

Conditions Propofol; Addictive Behaviors