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Pharmacodynamic observation of sedation with remimazolam combined with alfentanil in patients of different ages during gastroscopy

The cohort observational study of 50% effective dose of remimazolam combined with alfentanil for sedation during gastroscopy in patients of different ages

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100047947
Enrollment
Unknown
Registered
2021-06-28
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-03-07

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

Conditions

painless gastroscopy

Interventions

Youth group:Sedation / anesthesia for gastroscopy
Middle-aged group: Sedation / anesthesia for gastroscopy

Sponsors

Department of Anesthesiology, Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years (youth group: 18-39 years old, middle-aged group: 40-65 years old), gender is not limited; 2. Patients receiving routine gastroscopic diagnosis and treatment; 3. ASA score is I-II; 4. 18kg/m^2<BMI<30kg/m^2.

Exclusion criteria

Exclusion criteria: 1. Endoscopic diagnosis and treatment techniques that require complicated or noxious stimulation (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, peroral endoscopic myotomy, upper gastrointestinal foreign body removal, esophageal variceal ligation, upper gastrointestinal hemostasis, esophageal stenosis dilation, etc.); 2. The patient has severe communication impairment due to severe hearing deterioration and other reasons; 3. Pregnant or breastfeeding patients; 4. Patients with Mallampati grade >= grade III, restricted neck movement, short nail-mental distance (<6cm), etc. belong to difficult airway; 5. Participated in clinical trials of other drugs within 3 months before the screening period; 6. Patients with anemia, thrombocytopenia, abnormal liver function and renal function, or sitting systolic blood pressure <= 90mmHg, or unsatisfactory control of hypertension with antihypertensive drugs; 7. Patients with a history of drug abuse and/or alcohol abuse, benzodiazepines, opioids, propofol allergy within 2 years prior to screening; 8. Patients deemed inappropriate by the investigator to participate in this study.

Design outcomes

Primary

MeasureTime frame
modified observer's assessment of alertness/sedation;

Secondary

MeasureTime frame
blood pressure;heart rate;finger oxygen saturation;

Countries

China

Contacts

Public ContactZuo Ronghua

Xuzhou Medical University

zuomaybe@163.com+86 15505183533

Outcome results

None listed

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