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Study of the hypnotic effect and pharmacokinetics of remimazolam tosylate in volunteers with different level of obstructive sleep apnoea

Study of the hypnotic effect and pharmacokinetics of remimazolam tosylate in volunteers with different level of obstructive sleep apnoea

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400084817
Enrollment
Unknown
Registered
2024-05-24
Start date
2024-05-24
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Pharmacodynamic response of sedatives in subjects with different body weight and OSA levels

Interventions

Model establishment:The initial dose of remimazolam Tosylate will be infused at a rate of 0.2mg/kg/h, with an upregulation of 0.2mg/kg/h every 15 minutes. The infusion will be stopped when the suject
External Validation:The initial dose of remimazolam Tosylate will be infused at a rate of 0.2mg/kg/h, with an upregulation of 0.2mg/kg/h every 15 minutes. The infusion will be stopped when the subject

Sponsors

Eye & ENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 45 volunteers with different weight ranges, who received sleep monitoring in the sleep ward of Fudan University Affiliated Eye & ENT Hospital from May 2024 to Dec 2024 were included. Inclusion criteria: 1. 18-45 years old, 2. American Society of Anesthesiologists (ASA) Grades I-II, 3. Admission laboratory examination evaluates normal liver and kidney function, 4. 12 with normal weight (18.5 kg/m^2 = BMI = 35 kg/m^2), 5. Obtaining a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Allergy to any component of benzodiazepines and remimazolam tosylate; 2. Who have been using anesthetic analgesics, nonsteroidal anti-inflammatory drugs, and benzodiazepine hypnotics for a long time 3. With positive radial artery Allen test 4. Have participated in clinical trials of drugs or medical devices as a subject within the past 3 months 5. Donate more than 400 milliliters of blood within one month before the experiment 6. Pregnancy, lactation, potential pregnancy, and planned pregnancy; 7. History of abnormal recovery from previous surgical anesthesia: intraoperative awareness and postoperative delirium; 8. History of difficult tracheal intubation

Design outcomes

Primary

MeasureTime frame
the relationship between MOAA/S and the plasma concentrations of remimazolam tosylate;

Secondary

MeasureTime frame
Modified Observer’s Assessment of Alertness and Sedation scale, MOAA/S;Hemodynamic monitoring;Polysomnography (PSG);

Countries

China

Contacts

Public ContactYuan Han

Eye & ENT Hospital of Fudan University

hanyuan@eentanesthesia.com+86 21 6437 7134

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026