EuphoriaERGENCT06721195
Study on the Feelings of Euphoria Caused by Remimazolam During Gastroscopy and Colonoscopy and Their Related Factors
An observational study of Euphoria and Remimazolam Besylate, run by Zhangjie Yu at 1 site in China.
Trial summary
This study aims to investigate the incidence of euphoria induced by remimazolam during gastrointestinal endoscopy and explore its related factors. Gastrointestinal endoscopy, a minimally invasive procedure, often causes discomfort and anxiety for patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Euphoria, Remimazolam Besylate, Gastrointestinal Endoscopy
- What is being tested?
- Remimazolam for Gastrointestinal Endoscopy Sedation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 305 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Dec 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adult patients aged 18 to 65 years undergoing painless gastrointestinal endoscopy (gastroscopy, colonoscopy, or both) at a tertiary hospital. Participants must meet the inclusion criteria, such as ASA I-II classification and BMI between 18 and 28 kg/m². Patients are recruited from routine endoscopy appointments and provided written informed consent prior to participation. Exclusion criteria include severe comorbidities, psychiatric disorders, substance abuse, pregnancy, or recent participation in other clinical studies.
Who may be able to join
- Adults aged 18 to 65 years, regardless of gender.
- Patients scheduled for routine painless gastrointestinal endoscopy, including gastroscopy, colonoscopy, or both.
- ASA physical status classification: I or II.
- BMI between 18 kg/m² and 28 kg/m².
- Anticipated procedural duration of no more than 30 minutes.
- Patients who have provided written informed consent after understanding the study purpose, procedures, and potential risks.
Who cannot join
- History of psychiatric disorders such as schizophrenia, bipolar disorder, or personality disorders, or a history of alcohol, stimulant, or other substance abuse.
- Known allergies or intolerance to any medication used in the study, including remimazolam, sufentanil, or benzodiazepines.
- Patients requiring complex endoscopic procedures (e.g., ERCP, endoscopic submucosal dissection, endoscopic mucosal resection, or peroral endoscopic myotomy).
- History of severe hepatic or renal disease.
- Pregnant or lactating women.
- Participation in another clinical study within the past three months.
- Any condition or factor that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
brick yu, 02168383702, novo8yu@gmail.com
About this study
Official title: A Cross-Sectional Study on Euphoria Induced by Remimazolam During Gastrointestinal Endoscopy and Its Related Factors
This study aims to investigate the incidence of euphoria induced by remimazolam during gastrointestinal endoscopy and explore its related factors. Gastrointestinal endoscopy, a minimally invasive procedure, often causes discomfort and anxiety for patients. Remimazolam, a short-acting benzodiazepine, is increasingly used for sedation during these procedures due to its rapid onset, short metabolism, and controlled cardiorespiratory effects. This cross-sectional study will evaluate the effect of remimazolam on patient comfort, cooperation, and satisfaction during endoscopy, aiming to optimize sedation protocols and improve clinical outcomes.
- Conditions
- Euphoria, Remimazolam Besylate, Gastrointestinal Endoscopy
- Being tested
- Remimazolam for Gastrointestinal Endoscopy Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam for Gastrointestinal Endoscopy SedationDrug
This intervention involves the use of remimazolam, a short-acting benzodiazepine, for sedation during gastrointestinal endoscopy procedures (gastroscopy, colonoscopy, or both). Remimazolam is administered intravenously at an initial dose of 0.2-0.3 mg/kg, followed by additional doses of 2.5 mg as needed to maintain adequate sedation (MOAA/S score ≤ 2).
Unlike other benzodiazepines, remimazolam is rapidly metabolized by plasma esterases, resulting in a quick onset and recovery with minimal respiratory and cardiovascular depression. The study specifically evaluates the euphoria-inducing potential of remimazolam, using the ARCI-MBG scale pre- and post-procedure to assess its effect on patient comfort and satisfaction.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam Sedation Group | his cohort includes patients undergoing painless gastrointestinal endoscopy (gastroscopy, colonoscopy, or both) who receive sedation with remimazolam. The study aims to evaluate the incidence of euphoria induced by remimazolam and explore related factors. All patients receive sedation according to standard clinical guidelines, including pre-procedural sufentanil and lidocaine gel for oral preparation, followed by remimazolam for induction and maintenance.
Data collected include demographic characteristics, pre- and post-procedure euphoria scores assessed using the ARCI-MBG scale, perioperative safety indicators, and patient satisfaction. Receives: Drug: Remimazolam for Gastrointestinal Endoscopy Sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Euphoria Induced by Remimazolam
he occurrence of euphoria in patients undergoing sedation with remimazolam during gastrointestinal endoscopy procedures (gastroscopy, colonoscopy, or both). Euphoria is assessed using the ARCI-MBG scale. A positive result is defined as an increase in the ARCI-MBG score post-procedure compared to pre-procedure.
Measured: From pre-procedure baseline to 2 hours post-procedure (Euphoria is assessed at two time points: immediately before sedation and two hours after the procedure, upon full recovery.)
Secondary outcomes (1)
factors Associated with Euphoria Induced by Remimazolam
The identification of demographic, procedural, and clinical factors associated with the occurrence of euphoria induced by remimazolam during gastrointestinal endoscopy. Factors evaluated include age, gender, education level, BMI, ASA classification, comorbidities, dosage of remimazolam and sufentanil, procedural duration, perioperative adverse events, smoking and alcohol use, pre-procedural anxiety levels, and dream experiences.
Measured: From pre-procedure baseline to 2 hours post-procedure (Factors are collected before the procedure, during sedation, and 2 hours post-procedure, upon full recovery.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Aug 2024
- Primary completion31 Oct 2024
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for EuphoriaStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 305 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Zhangjie Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhangjie Yu, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721195
- Sponsor's protocol ID
- LY2024-174-B
- Acronym
- ERGE
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared. Data will include demographic characteristics, procedural details, and outcome measures. Access will be granted to qualified researchers upon request via a secure data repository.
Publications
Basturk A, Artan R, Yilmaz A. Efficacy and safety of midazolam and ketamine in paediatric upper endoscopy. Arab J Gastroenterol. 2017 Jun;18(2):80-82. doi: 10.1016/j.ajg.2017.05.004. Epub 2017 Jun 1.
PubMed 28579345Brechmann T, Maier C, Kaisler M, Vollert J, Schmiegel W, Pak S, Scherbaum N, Rist F, Riphaus A. Propofol sedation during gastrointestinal endoscopy arouses euphoria in a large subset of patients. United European Gastroenterol J. 2018 May;6(4):536-546. doi: 10.1177/2050640617736231. Epub 2017 Oct 4.
PubMed 29881609Schippers F, Pesic M, Saunders R, Borkett K, Searle S, Webster L, Stoehr T. Randomized Crossover Trial to Compare Abuse Liability of Intravenous Remimazolam Versus Intravenous Midazolam and Placebo in Recreational Central Nervous System Depressant Users. J Clin Pharmacol. 2020 Sep;60(9):1189-1197. doi: 10.1002/jcph.1614. Epub 2020 Jun 3.
PubMed 32495449Ciraulo DA, Knapp CM, LoCastro J, Greenblatt DJ, Shader RI. A benzodiazepine mood effect scale: reliability and validity determined for alcohol-dependent subjects and adults with a parental history of alcoholism. Am J Drug Alcohol Abuse. 2001 May;27(2):339-47. doi: 10.1081/ada-100103713.
PubMed 11417943Tezcan AH, Ornek DH, Ozlu O, Baydar M, Yavuz N, Ozaslan NG, Dilek K, Keske A. Abuse potential assessment of propofol by its subjective effects after sedation. Pak J Med Sci. 2014 Nov-Dec;30(6):1247-52. doi: 10.12669/pjms.306.5811.
PubMed 25674117Zhao K, Yang N, Yue J, Han Y, Wang X, Kang N, Zhang T, Guo X, Xu M. Factors associated with euphoria in a large subset of cases using propofol sedation during gastrointestinal endoscopy. Front Psychiatry. 2023 Apr 27;14:1001626. doi: 10.3389/fpsyt.2023.1001626. eCollection 2023.
PubMed 37181900
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-Sectional Study on Euphoria Induced by Remimazolam During Gastrointestinal Endoscopy and Its Related Factors
- ClinicalTrials.gov ID
- NCT06721195
- Acronym / sponsor ID
- ERGE / LY2024-174-B
- Conditions
- Euphoria, Remimazolam Besylate, Gastrointestinal Endoscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 305 participants (estimated)
- Lead sponsor
- Zhangjie YuUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Dec 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.
This study aims to investigate the incidence of euphoria induced by remimazolam during gastrointestinal endoscopy and explore its related factors. Gastrointestinal endoscopy, a minimally invasive procedure, often causes discomfort and anxiety for patients. Remimazolam, a short-acting benzodiazepine, is increasingly used for sedation during these procedures due to its rapid onset, short metabolism, and controlled cardiorespiratory effects. This cross-sectional study will evaluate the effect of remimazolam on patient comfort, cooperation, and satisfaction during endoscopy, aiming to optimize sedation protocols and improve clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remimazolam Sedation Group | – | Drug: Remimazolam for Gastrointestinal Endoscopy Sedationhis cohort includes patients undergoing painless gastrointestinal endoscopy (gastroscopy, colonoscopy, or both) who receive sedation with remimazolam. The study aims to evaluate the incidence of euphoria induced by remimazolam and explore related factors. All patients receive sedation according to standard clinical guidelines, including pre-procedural sufentanil and lidocaine gel for oral preparation, followed by remimazolam for induction and maintenance. Data collected include demographic characteristics, pre- and post-procedure euphoria scores assessed using the ARCI-MBG scale, perioperative safety indicators, and patient satisfaction. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult patients aged 18 to 65 years undergoing painless gastrointestinal endoscopy (gastroscopy, colonoscopy, or both) at a tertiary hospital. Participants must meet the inclusion criteria, such as ASA I-II classification and BMI between 18 and 28 kg/m². Patients are recruited from routine endoscopy appointments and provided written informed consent prior to participation. Exclusion criteria include severe comorbidities, psychiatric disorders, substance abuse, pregnancy, or recent participation in other clinical studies.
Key inclusion criteria (6 listed)
- Adults aged 18 to 65 years, regardless of gender.
- Patients scheduled for routine painless gastrointestinal endoscopy, including gastroscopy, colonoscopy, or both.
- ASA physical status classification: I or II.
- BMI between 18 kg/m² and 28 kg/m².
- Anticipated procedural duration of no more than 30 minutes.
Key exclusion criteria (7 listed)
- History of psychiatric disorders such as schizophrenia, bipolar disorder, or personality disorders, or a history of alcohol, stimulant, or other substance abuse.
- Known allergies or intolerance to any medication used in the study, including remimazolam, sufentanil, or benzodiazepines.
- Patients requiring complex endoscopic procedures (e.g., ERCP, endoscopic submucosal dissection, endoscopic mucosal resection, or peroral endoscopic myotomy).
- History of severe hepatic or renal disease.
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remimazolam for Gastrointestinal Endoscopy SedationThis intervention involves the use of remimazolam, a short-acting benzodiazepine, for sedation during gastrointestinal endoscopy procedures (gastroscopy, colonoscopy, or both). Remimazolam is administered intravenously at an initial dose of 0.2-0.3 mg/kg, followed by additional doses of 2.5 mg as needed to maintain adequate sedation (MOAA/S score ≤ 2). Unlike other benzodiazepines, remimazolam is rapidly metabolized by plasma esterases, resulting in a quick onset and recovery with minimal respiratory and cardiovascular depression. The study specifically evaluates the euphoria-inducing potential of remimazolam, using the ARCI-MBG scale pre- and post-procedure to assess its effect on patient comfort and satisfaction. | Drug | Remimazolam Sedation Group |
Primary outcome
Incidence of Euphoria Induced by Remimazolam
Time frame: From pre-procedure baseline to 2 hours post-procedure (Euphoria is assessed at two time points: immediately before sedation and two hours after the procedure, upon full recovery.)
he occurrence of euphoria in patients undergoing sedation with remimazolam during gastrointestinal endoscopy procedures (gastroscopy, colonoscopy, or both). Euphoria is assessed using the ARCI-MBG scale. A positive result is defined as an increase in the ARCI-MBG score post-procedure compared to pre-procedure.
1 secondary outcome
factors Associated with Euphoria Induced by Remimazolam
Time frame: From pre-procedure baseline to 2 hours post-procedure (Factors are collected before the procedure, during sedation, and 2 hours post-procedure, upon full recovery.)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 28579345Basturk A, Artan R, Yilmaz A. Efficacy and safety of midazolam and ketamine in paediatric upper endoscopy. Arab J Gastroenterol. 2017 Jun;18(2):80-82. doi: 10.1016/j.ajg.2017.05.004. Epub 2017 Jun 1.
- Background: PubMed 29881609Brechmann T, Maier C, Kaisler M, Vollert J, Schmiegel W, Pak S, Scherbaum N, Rist F, Riphaus A. Propofol sedation during gastrointestinal endoscopy arouses euphoria in a large subset of patients. United European Gastroenterol J. 2018 May;6(4):536-546. doi: 10.1177/2050640617736231. Epub 2017 Oct 4.
- Background: PubMed 32495449Schippers F, Pesic M, Saunders R, Borkett K, Searle S, Webster L, Stoehr T. Randomized Crossover Trial to Compare Abuse Liability of Intravenous Remimazolam Versus Intravenous Midazolam and Placebo in Recreational Central Nervous System Depressant Users. J Clin Pharmacol. 2020 Sep;60(9):1189-1197. doi: 10.1002/jcph.1614. Epub 2020 Jun 3.
- Background: PubMed 11417943Ciraulo DA, Knapp CM, LoCastro J, Greenblatt DJ, Shader RI. A benzodiazepine mood effect scale: reliability and validity determined for alcohol-dependent subjects and adults with a parental history of alcoholism. Am J Drug Alcohol Abuse. 2001 May;27(2):339-47. doi: 10.1081/ada-100103713.
- Background: PubMed 25674117Tezcan AH, Ornek DH, Ozlu O, Baydar M, Yavuz N, Ozaslan NG, Dilek K, Keske A. Abuse potential assessment of propofol by its subjective effects after sedation. Pak J Med Sci. 2014 Nov-Dec;30(6):1247-52. doi: 10.12669/pjms.306.5811.
- Background: PubMed 37181900Zhao K, Yang N, Yue J, Han Y, Wang X, Kang N, Zhang T, Guo X, Xu M. Factors associated with euphoria in a large subset of cases using propofol sedation during gastrointestinal endoscopy. Front Psychiatry. 2023 Apr 27;14:1001626. doi: 10.3389/fpsyt.2023.1001626. eCollection 2023.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared. Data will include demographic characteristics, procedural details, and outcome measures. Access will be granted to qualified researchers upon request via a secure data repository.
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.
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 Euphoria and Remimazolam Besylate, run by Zhangjie Yu 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 7 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: looking for participants now, as of the sponsor's last update on 6 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhangjie Yu, M.Sc. (0086-13761067441, novo8yu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Euphoria Induced by Remimazolam (time frame: From pre-procedure baseline to 2 hours post-procedure (Euphoria is assessed at two time points: immediately before sedation and two hours after the procedure, upon full recovery.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06721195, which also lists 6 linked publications.
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 6 Dec 2024.