Euphoria, Gastrointestinal Endoscopy, Remimazolam Besylate
Conditions
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.
Interventions
DRUGRemimazolam 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.
Sponsors
Zhangjie Yu
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Euphoria Induced by Remimazolam | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| factors Associated with Euphoria Induced by Remimazolam | 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.) | 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. |
Countries
China
Contacts
Primary ContactZhangjie Yu, M.Sc.
Outcome results
None listed