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Randomized controlled trial of the efficacy and safety of the remimazolam besylate for gastroenteroscopy sedation in patients with suspected sleep apnea

Randomized controlled trial of the efficacy and safety of the remimazolam besylate for gastroenteroscopy sedation in patients with suspected sleep apnea

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074758
Enrollment
Unknown
Registered
2023-08-15
Start date
2023-04-10
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

remimazolam besylate for gastroenteroscopy sedation in patients with confirmed or suspected sleep apnea

Interventions

Remimazolam group:Remimazolam was sedated at 0.2-0.3mg/kg
Propofol group:Propofol was sedated at 2-2.5mg/kg

Sponsors

The first affiliated hospital of Fujian Medical University,China.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ?ASA Grade?~?;?Age 18~65 years old?Patients with suspected sleep apnea ;?Patients underwent agastroenteroscopy sedation under intravenous anesthesia ;?clearly understand and voluntarily participate in the study,signed by the informed consent.

Exclusion criteria

Exclusion criteria: ? Patients with psychiatric and neurological disorders;?People who take psychotropic drugs such as diazepam and anti-anxiety,and those who abuse alcohol or drugs;?Patients with speech,vision or hearing impairments;?Patients who are allergic or contraindicated to benzodiazepines,propofol,remifentanil and their drug components;?Serious cardiac and pulmonary disorders( MET2,cardiacfuction>2,SPO2<92%);?Severe liver((Child-PughC grade or above) and autofunctionimpairment;?Patients with unsatisfactory blood pressure control treated with antihypertensive drugs(sit-systolic blood pressure =180mmHg and diastolic blooc pressure=100mmHg during screening period);?Severe OSAHS requiring CPAP treatment;?Patients with acute respiratory in flammation during asthma attack or 2 weeks and not cured;?Patients who participated in the clinical trial of remimazolam or other drugs foe nearly 3 months; ?Before the preoperative visit had knowm obvious difficult airway(midified Mallampati? grade) and other researchers believed that may affect the safety of patients during the study);?Acute heart failure;unstable angina;myocardial infarction within 6 months before screening;restingcardiogram heart rate<50 beats/min;third degree atrioventricular biock;severe teicuspid valve insufficiency;severe arrhythmia;?Without an escort or guardian;?Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
hyoxemia;

Secondary

MeasureTime frame
hypotension;Addotional drug inventory;

Countries

China

Contacts

Public ContactKai Zeng

The first affiliated hospital of Fujian Medical University,China.

Zengkai6822@163.com+86 130 5529 1712

Outcome results

None listed

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