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ED90 of Remimazolam Besylate Combined with Different Doses of Alfentanil for Inhibiting Gastroscopic Insertion Reactions in Obese Patients: A Biased-Coin Sequential Allocation Dose-Finding Trial

ED90 of Remimazolam Besylate Combined with Different Doses of Alfentanil for Inhibiting Gastroscopic Insertion Reactions in Obese Patients: A Biased-Coin Sequential Allocation Dose-Finding Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122945
Enrollment
Unknown
Registered
2026-04-20
Start date
2026-04-20
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Painless Gastroscopy

Interventions

Low-dose Alfentanil Group:A low dose of 5 µg/kg alfentanil was administered intravenously,followed by an initial dose of 0.15 mg/kg remimazolam administered intravenously.
Medium-dose Alfentanil Group:A medium dose of 10 µg/kg alfentanil was administered intravenously,followed by an initial dose of 0.10 mg/kg remimazolam administered intravenously.

Sponsors

The First Affiliated Hospital of Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years old;? 2. Body Mass Index (BMI) between 30 and 39.9 Kg/m²;? 3. American Society of Anesthesiologists (ASA) physical status classification of Class I, II, and stable Class III

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to the drugs used; 2. History of alcohol abuse; 3. Use of opioids or benzodiazepines within 6 months; 4. Refusal of anesthesia; 5. Uncontrolled severe hypertension (SBP >= 180 mmHg, DBP >= 110 mmHg); 6. Recent respiratory tract infection, history of asthma, chronic obstructive pulmonary disease (COPD) or other respiratory diseases; 7. History of liver dysfunction (Child-Pugh Class B or above) or renal dysfunction; 8. History of cardiovascular diseases; patients with pyloric obstruction, achalasia, or a history of upper gastrointestinal surgery; 9. Patients with mental illness or inability to communicate effectively; 10. Patients undergoing complex or therapeutic gastroscopy; 11. Expected difficult airway (Mallampati classification >= Grade 3); 12. Patients suspected of having obstructive sleep apnea-hypopnea syndrome (OSAHS history).

Design outcomes

Primary

MeasureTime frame
ED50;

Secondary

MeasureTime frame
Systolic Blood Pressure (SBP);Hypotension; Hypoxemia; Bradycardia; Singultus; Injection pain; Nausea and vomiting;Diastolic Blood Pressure (DBP);Mean Arterial Pressure (MAP);Pulse Oxygen Saturation (SpO?);Heart Rate (HR);

Countries

China

Contacts

Public ContactXiao Song

Department of Anesthesiology and Perioperative Medicine, The First Affiliated Hospital of Shandong First Medical University

songxiao0364@163.com+86 531 8926 8535

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026