PropofolNCT06602297
Propofol-related Euphoria in Pain-free Gastrointestinal Endoscopy Patients
An observational study of Propofol and Addictive Behaviors, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Propofol, Addictive Behaviors
- How many people
- 986 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult Participants with ASA I-II Proposed for Painless Gastrointestinal Endoscopy
Who may be able to join
- 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.
Who cannot join
- 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.);
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single-center, Cross-sectional Clinical Investigation of Propofol-related Euphoria in Pain-free Gastrointestinal Endoscopy Patients
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
- Medical subject headings
- Behavior, Addictive
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: within half an hour after the operation, postoperative days 1 ,3 and 7
Secondary outcomes (7)
Anxiety level
Face-to-face questioning or follow-up via telephone, questioning the disease to record the anxiety level, using the NRS rating, which represents the anxiety level through ten numbers from 0-10, with 0 being no anxiety at all and 10 being the most intense anxiety.
Measured: preoperatively , within half an hour after the operation, postoperative days 1,3 and 7
Subject satisfaction with the quality of perioperative anesthesia
Assessment method: in person or through telephone follow-up, the subjects were asked to measure their satisfaction with the intraoperative and postoperative resuscitation periods as well as the entire period after discharge, which was rated by NRS, and satisfaction was represented by ten numbers from 0-10, with 0 being unsatisfactory and 10 being the most satisfactory.
Measured: 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
If the subject was able to recall the dream, the dream was rated on a Likert questionnaire: 1. the mood of the dream: 1-5, 1 as very sad, 5 as very happy; 2. the extent to which the dream was remembered; 1-5, 1 as not remembering at all, 5 as remembering at all: 3. the sounds in the dream: 1-5, 1 as not at all, 5 as all of them; 4. the movements in the dream: 1-5 1 for not at all, 5 for all of them.
Calculate the sum of the Dreamland Likert questionnaire scores.
Measured: Within half an hour after the operation
The number of times of sleep in the 72h postoperative period
The number of times of sleep were asked and recorded during the 72h period after painless gastrointestinal endoscopy by telephone follow-up.
Measured: Postoperative days 1 and 3
the duration of each sleep in the 72h postoperative period
The duration of each sleep were asked and recorded during the 72h period after painless gastrointestinal endoscopy by telephone follow-up.
Measured: Postoperative days 1 and 3
the quality of sleep each time in the 72h postoperative period
Ask for and record the quality of sleep each time through telephone follow-ups The quality of sleep was categorized into five grades of "very good, good, fair, bad, and very bad" . Each grade corresponds to 5, 4, 3, 2, and 1 points.
Measured: Postoperative days 1 and 3
Perioperative adverse events
In-person questioning or telephone follow-up, using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, to determine perioperative adverse events and assess the severity of the adverse events against the feedback collected from the subjects.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start18 Sep 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PropofolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 986 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju Gao, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602297
- Sponsor's protocol ID
- 2024ky248
- Status last verified
- Dec 2025
- First submitted
- 10 Sep 2024
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Cross-sectional Clinical Investigation of Propofol-related Euphoria in Pain-free Gastrointestinal Endoscopy Patients
- ClinicalTrials.gov ID
- NCT06602297
- Acronym / sponsor ID
- 2024ky248
- Conditions
- Propofol, Addictive Behaviors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 986 participants (actual)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Participants with ASA I-II Proposed for Painless Gastrointestinal Endoscopy
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of propofol-related euphoria
Time frame: preoperatively , within half an hour after the operation, postoperative days 1 ,3 and 7
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.
Severity of propofol-related euphoria
Time frame: preoperatively , within half an hour after the operation, postoperative days 1,3 and 7
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.
Duration of propofol-related euphoria
Time frame: within half an hour after the operation, postoperative days 1 ,3 and 7
Postoperatively, subjects were asked about changes in mood compared to baseline values by the same method, and their duration was confirmed.
7 secondary outcomes
Anxiety level
Time frame: preoperatively , within half an hour after the operation, postoperative days 1,3 and 7
Subject satisfaction with the quality of perioperative anesthesia
Time frame: 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
Time frame: Within half an hour after the operation
The number of times of sleep in the 72h postoperative period
Time frame: Postoperative days 1 and 3
the duration of each sleep in the 72h postoperative period
Time frame: Postoperative days 1 and 3
the quality of sleep each time in the 72h postoperative period
Time frame: Postoperative days 1 and 3
Perioperative adverse events
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Propofol and Addictive Behaviors, run by Northern Jiangsu People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of propofol-related euphoria (time frame: preoperatively , within half an hour after the operation, postoperative days 1 ,3 and 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.