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Study on 90 % effective dose of remimazolam combined with sufentanil in adult gastroscopy

Study on 90 % effective dose of remimazolam combined with sufentanil in adult gastroscopy

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200062381
Enrollment
Unknown
Registered
2022-08-03
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

painless gastroscopy

Interventions

one:Intravenous injection of different doses of rimimazolam

Sponsors

Zhuji People ' s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Gastroscopy ; 2. 18-65 years old ; 3. American anesthesiologist association ( ASA ) was graded as I – II ; 4. Body mass index ( BMI ) 18-28 kg / m2.

Exclusion criteria

Exclusion criteria: 1 Patients with severe respiratory diseases ( obstructive sleep apnea syndrome, acute respiratory infection, acute exacerbation of chronic obstructive pulmonary disease, uncontrolled asthma, etc. ) ; 2 Evaluation of patients with difficult airway ( modified Mallampati score IV, mouth opening limitation, mandibular, thyromental distance less than 6cm or less than the three transverse fingers ) ; 3 history of sleep apnea ; 4 patients with acute heart failure, unstable angina, and myocardial infarction within 6 months before screening ; 5 The hemodynamics was not stable ( systolic pressure [ SBP ] 180 mmHg, diastolic pressure DBP > 110 mmHg, and peripheral blood oxygen saturation [ SpO2 ] < 90 % ) ; 6 liver dysfunction ( aspartate aminotransferase ( AST ) and / or alanine aminotransferase ( ALT ) were higher than the 2.5 - fold normal upper limit, total bilirubin ( TBIL ) was higher than the 1.5 - fold normal upper limit, or renal dysfunction ( arginine or arginine nitrogen was higher than the normal upper limit, serum creatine was higher than the normal upper limit ) ; 7 patients with mental disorders ( schizophrenia, mania, bipolar disorder, mental disorders, etc. ), long-term use of psychotropic drugs, and cognitive impairment ; 8 Have a long history of taking mental or sedative hypnotic drugs. 9 History of drug abuse and alcohol consumption ( alcohol abuse : average daily consumption of more than 2 units of alcohol [ 1 unit = 360 mL beer or 45 mL 40 % liquor or 150 mL liquor ] ) ; 10 pregnant or lactating women, or family planning within 3 months ( including men ) ; 11 allergies or taboos against benzodiazepines, opioids, propofol and their components ; 12 patients who participated in other drug trials within three months before the study.

Design outcomes

Primary

MeasureTime frame
ED90 of remimazolam combined with sufentanil in adult gastroscopy;

Secondary

MeasureTime frame
Induction dose of rimimazom;time before falling asleep;examination time;Drug addition name;administration timing of drug;Arousal time after gastroscopy;systolic blood pressure;diastolic pressure;Mean arterial pressure;respiratory rate;heart rate;oxygen saturation;

Countries

China

Contacts

Public ContactYan Chen

Zhuji People's Hospital

1844786725@qq.com+86 13606853009

Outcome results

None listed

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