Study on the Feelings of Euphoria Caused by Remimazolam During Gastroscopy and Colonoscopy and Their Related Factors
NCT ID: NCT06721195
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
305 participants
OBSERVATIONAL
2024-08-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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.
Remimazolam for Gastrointestinal Endoscopy Sedation
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.
Interventions
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Remimazolam for Gastrointestinal Endoscopy Sedation
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Zhangjie Yu
OTHER
Responsible Party
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Zhangjie Yu
Attending Physician
Locations
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Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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brick yu
Role: primary
References
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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.
Brechmann 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.
Schippers 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.
Ciraulo 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.
Tezcan 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.
Zhao 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.
Other Identifiers
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LY2024-174-B
Identifier Type: -
Identifier Source: org_study_id