Propofol-related Euphoria in Pain-free Gastrointestinal Endoscopy Patients

NCT06602297 | Completed

• 1 other identifier: 2024ky248
• Study Type: observational
• Target: 986
• Locations: 1 country
• Sites: 1

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

Conditions

Propofol; Addictive Behaviors

Outcome Measures

Primary Outcomes (3)

• Incidence of propofol-related euphoria

  Subjects were asked in person or through telephone follow-up, "To what extent do you think you are feeling pleasure and euphoria now?". The NRS is a numerical rating scale (NRS) that represents feelings of euphoria on a scale of 0-10, with 0 being no feelings of euphoria at all and 10 being the strongest feelings of euphoria.

  preoperatively , within half an hour after the operation, postoperative days 1 ,3 and 7

• Severity of propofol-related euphoria

  Subjects were asked in person or via telephone follow-up, "Has your pleasant, euphoric mood changed now compared to before surgery?" , using the Likert questionnaire score (5-Point Likert Scale, Likert): 0 indicates that the mood is significantly worse than before; 1 indicates that the mood is mildly worse than before; 2 indicates that there is no change in euphoria; 3 indicates that there is a mild euphoria; and 4 indicates that there is a markedly euphoric mood.

  preoperatively , within half an hour after the operation, postoperative days 1,3 and 7

• Duration of propofol-related euphoria

  Postoperatively, subjects were asked about changes in mood compared to baseline values by the same method, and their duration was confirmed.

  within half an hour after the operation, postoperative days 1 ,3 and 7

Secondary Outcomes (7)

• Anxiety level

  preoperatively , within half an hour after the operation, postoperative days 1,3 and 7

• Subject satisfaction with the quality of perioperative anesthesia

  at postoperative days 1 after the subject had recovered from all adverse events, if the subject did not have a perioperative adverse event

• Content of Memory of Intraoperative Dreams

  Within half an hour after the operation

• The number of times of sleep in the 72h postoperative period

  Postoperative days 1 and 3

• the duration of each sleep in the 72h postoperative period

  Postoperative days 1 and 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult Participants with ASA I-II Proposed for Painless Gastrointestinal Endoscopy

You may qualify if:

• Proposed to perform painless GI endoscopy, and simple endoscopic maneuvers such as single small polyp clamping, performing HP examination, etc;
• Gender is not limited;
• years old ≤ 80 years old;
• ASA classification: I-II;
• kg/m2 \<BMI \<30 kg/m2;
• Informed consent, voluntary participation in the trial, and informed consent signed by the subjects themselves.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

Study Sites (1)

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

Location

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: September 18, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

CN (1)