Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06721195

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Euphoria Gastrointestinal Endoscopy Remimazolam Besylate

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location status: Recruiting

Location contact

brick yu

CONTACT

[email protected]

02168383702

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remimazolam for Gastrointestinal Endoscopy Sedation

Drug

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.

Primary outcomes

  1. Incidence of Euphoria Induced by Remimazolam

    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.)

    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 outcomes

  1. factors Associated with Euphoria Induced by Remimazolam

    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.)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhangjie Yu, M.Sc.

CONTACT

[email protected]

0086-13761067441

Sponsors and collaborators

Lead sponsor

Zhangjie Yu

Other

Registry information

Official study title

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

Acronym: ERGE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.