Dose find for remimazolam plus alfentanil for gastroscopy in obese adults
Official title: 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
Run by Qianfoshan Hospital · NCT07925684 · Data updated 2026-11-12
This trial tests what dose of remimazolam besylate with alfentanil best sedates obese adults during gastroscopy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Qianfoshan Hospital Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Status | Recruiting |
| Started | April 20, 2026 |
| Main results expected | November 2026 |
| Study ends | November 2026 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT07925684 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with BMI 30–39.9 kg/m2 and ASA I–II or stable III, undergoing gastroscopy.
✕Probably not a fit
Patients who do not respond to the chosen sedation protocol or have contraindications may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, dose-finding study in obese adults undergoing gastroscopy to identify the 90% effective dose (ED90) of a remimazolam and alfentanil combination. A biased-coin up-and-down sequential design is used to establish safe and effective dosing, with two parallel groups (L and M) and independent sequence generation to maintain allocation concealment. Sedation depth and safety will be monitored throughout the procedure, with standard monitoring and adverse event surveillance. The trial aims to optimize dosing to minimize respiratory events while achieving adequate sedation. Eligible participants are adults 18–65 with BMI 30–39.9 kg/m2 and ASA I–II or stable III.
Why it matters
Potential benefit: If successful, the regimen could provide a safer, more effective sedation option for obese patients undergoing gastroscopy.
How similar studies have gone: Prior studies in sedation found that remimazolam-based combinations can offer effective sedation with favorable safety profiles, though this exact combination and dose-finding approach is novel in this population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Allergic to benzodiazepines and opioids * Refusal of anesthesia * Use of opioids or benzodiazepines within the past 6 months * 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 * Anticipated difficult airway
Where it's running
-
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China Recruiting
Study contacts
- Principal investigator: Jianbo Wu — Shandong First Medical University
- Study coordinator: Xiao Song
- Email: songxiao0364@163.com
- Phone: +86 15628773255
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.