Comparing Remimazolam and Propofol for sedation during endoscopic procedures
The Comparison of Remimazolam or Propofol Used Alone Versus in Combination for Moderate Sedation During Endoscopic Examination and Treatment.
This study is testing whether using Remimazolam alone, Propofol alone, or a combination of both can provide better and safer sedation for patients undergoing endoscopic procedures.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Kaohsiung Veterans General Hospital. Academic / other |
| Locations | 1 site (Kaohsiung City) |
| Trial ID | NCT06777758 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of Remimazolam, both alone and in combination with Propofol, for moderate sedation during endoscopic examinations and treatments. It is a prospective, randomized, single-center study where eligible patients will be divided into three groups: one receiving Propofol, another receiving Remimazolam, and the last receiving both medications. The study will monitor various parameters including anesthesia depth, vital signs, recovery times, and patient satisfaction to determine the best sedation approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20-80 years undergoing upper gastrointestinal endoscopic examinations or therapies with an ASA classification of I to III.
Not a fit: Patients with allergies to Propofol or Remimazolam, those requiring emergency surgery, or individuals with significant liver or kidney impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve sedation practices during endoscopic procedures, leading to better patient outcomes and reduced postoperative complications.
How similar studies have performed: Other studies have shown promising results with similar sedation approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects are between 20-80 years old. * Anesthesiologists rated ASA as between I and III. * Patients undergoing upper gastrointestinal endoscopic examination or therapy. Exclusion Criteria: * Allergy to Propofol, Remimazolam, or opioid medications. * Emergency surgery. * Pregnancy. * History of malignant hyperthermia. * Impaired liver or kidney function. * Airway difficulties due to pharyngeal tumors. * Refusal to participate.
Where this trial is running
Kaohsiung City
- Kaohsiung Veterans General Hospital — Kaohsiung City, Taiwan (Recruiting)
Study contacts
- Principal investigator: Chia-Hao Yang, M.d — employe
- Study coordinator: Yuan-Yi Chia, M.D
- Email: yychia@vghks.gov.tw
- Phone: 886-7-342-2121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.