Study on the Feelings of Euphoria Caused by Remimazolam During Gastroscopy and Colonoscopy and Their Related Factors

Recruiting

• Conditions: Euphoria; Remimazolam Besylate; Gastrointestinal Endoscopy
• Interventions: Drug: Remimazolam for Gastrointestinal Endoscopy Sedation

• Registration Number: NCT06721195
• Lead Sponsor: Zhangjie Yu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-01
• Primary Completion: 2024-10-31
• Status Verified: 2024-12
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 305

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Remimazolam Sedation Group	Remimazolam for Gastrointestinal Endoscopy Sedation	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China