Clinical trial NCT06602297: Propofol-related Euphoria in Pain-free Gastrointestinal Endoscopy Patients
Official title: A Prospective, Single-center, Cross-sectional Clinical Investigation of Propofol-related Euphoria in Pain-free Gastrointestinal Endoscopy Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Propofol
Addictive Behaviors
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 986
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult Participants with ASA I-II Proposed for Painless Gastrointestinal Endoscopy

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 of a single-center, cross-sectional clinical research study


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 \&amp;lt;BMI \&amp;lt;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.

Primary outcomes:
measure: Incidence of propofol-related euphoria
timeFrame: preoperatively , within half an hour after the operation, postoperative days 1 ,3 and 7
measure: Severity of propofol-related euphoria
timeFrame: preoperatively , within half an hour after the operation, postoperative days 1,3 and 7
measure: Duration of propofol-related euphoria
timeFrame: within half an hour after the operation, postoperative days 1 ,3 and 7
Secondary outcomes:
measure: Anxiety level
timeFrame: preoperatively , within half an hour after the operation, postoperative days 1,3 and 7
measure: Subject satisfaction with the quality of perioperative anesthesia
timeFrame: at postoperative days 1 after the subject had recovered from all adverse events, if the subject did not have a perioperative adverse event
measure: Content of Memory of Intraoperative Dreams
timeFrame: Within half an hour after the operation
measure: The number of times of sleep in the 72h postoperative period
timeFrame: Postoperative days 1 and 3
measure: the duration of each sleep in the 72h postoperative period
timeFrame: Postoperative days 1 and 3
measure: the quality of sleep each time in the 72h postoperative period
timeFrame: Postoperative days 1 and 3
measure: Perioperative adverse events
timeFrame: 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.
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
Study officials:
References: