Clinical trial NCT06721195: Study on the Feelings of Euphoria Caused by Remimazolam During Gastroscopy and Colonoscopy and Their Related Factors
Official title: A Cross-Sectional Study on Euphoria Induced by Remimazolam During Gastrointestinal Endoscopy and Its Related Factors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Euphoria
Remimazolam Besylate
Gastrointestinal Endoscopy
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of Euphoria Induced by Remimazolam
timeFrame: 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:
measure: factors Associated with Euphoria Induced by Remimazolam
timeFrame: 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.)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.