Study on the Feelings of Euphoria Caused by Remimazolam During Gastroscopy and Colonoscopy and Their Related Factors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorZhangjie Yu
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Remimazolam for Gastrointestinal Endoscopy Sedation
DrugThis 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.
Treatment groups
305 Participants
are divided into 1 treatment groupGroup A: Remimazolam Sedation Group1 intervention
Trial outcomes
Primary outcomes
1
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.
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.)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.
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.)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhangjie Yu
Lead sponsor
RenJi Hospital
Sponsor institution
Source ClinicalTrials.gov