Study on the Feelings of Euphoria Caused by Remimazolam During Gastroscopy and Colonoscopy and Their Related Factors
A Cross-Sectional Study on Euphoria Induced by Remimazolam During Gastrointestinal Endoscopy and Its Related Factors
Zhangjie Yu
305 participants
Aug 1, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria7
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06721195