A Cross-Sectional Study on Euphoria Induced by Remimazolam During Gastrointestinal Endoscopy and Its Related Factors

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Zhangjie Yu, M.Sc.
novo8yu@gmail.com
0086-13761067441
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 305
Treatments
Remimazolam Sedation Group
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.
Related Therapeutic Areas
Sponsors
Leads: Zhangjie Yu

This content was sourced from clinicaltrials.gov