Determination of ED90 of Remimazolam Besylate Combined With Alfentanil for Gastroscopy Sedation in Obese Patients
Key facts
- Where
- Jinan, KínaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Forrás: NCT07925684: ki vehet részt
Where in Kína
- The First Affiliated Hospital of Shandong First Medical UniversityJinan, KínaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jianbo Wu
- Trial code
- NCT07925684
- Record updated
- 2026. november 9.
- Original description
This study aims to find the suitable dose of remimazolam combined with alfentanil for sedation during gastroscopy in obese patients. We will use a biased coin up-and-down sequential design to identify the 90% effective dose (ED90). Sedation effect and safety will be assessed. All participants will have standard monitoring during the procedure, and any adverse events will be closely watched.Read full original descriptionShow less
ED₉₀ of Remimazolam Besylate Combined With Different Doses of Alfentanil for Inhibiting Gastroscopic Insertion Reactions in Obese Patients: A Dose-Finding Trial With Biased-Coin Sequential Allocation
This study aims to find the suitable dose of remimazolam combined with alfentanil for sedation during gastroscopy in obese patients. We will use a biased coin up-and-down sequential design to identify the 90% effective dose (ED90). Sedation effect and safety will be assessed. All participants will have standard monitoring during the procedure, and any adverse events will be closely watched.
Inclusion: Patients aged 18 to 65 years; Body mass index (BMI) between 30 and 39.9 kg/m²; American Society of Anesthesiologists physical status grade I-II or stable grade III.
Exclusion: Allergic to benzodiazepines and opioids; History of alcohol abuse; Uncontrolled severe hypertension (systolic blood pressure (SBP) ≥180 mmHg and/or diastolic blood pressure (DBP) ≥110 mmHg); Recent respiratory infection, or a history of asthma, chronic obstructive pulmonary disease (COPD), or other respiratory diseases; Liver dysfunction (Child-Pugh B or higher); chronic kidney disease stage 3-5; History of cardiovascular disease; Psychiatric disorders or inability to communicate effectively; Pyloric obstruction, achalasia, or a history of upper gastrointestinal surgery; or scheduled for complex or therapeutic gastroscopy; Refusal of anesthesia; Use of opioids or benzodiazepines within the past 6 months; Anticipated difficult airway.