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Establishment and accuracy evaluation of remimazolam target controlled infusion system

Establishment and accuracy evaluation of remimazolam target controlled infusion system

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063273
Enrollment
Unknown
Registered
2022-09-02
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Intraoperative sedation

Interventions

group 1:Intravenous infusion of remimazolam at a constant rate
group 2:Target controlled infusion of Remimazolam

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Stage 1: 1. ASA grade 1; 2. Who proposed a bilateral hallux valgus osteotomy under lumbar-hard combined anesthesia; 3. Aged 18–65 years; 4. Body mass index of 18 – 30 kg/m2; 5. Signed the informed consent. Stage 2: 1. ASA grade 1; 2. Who planned to undergo elective lower limb surgery under lumbar-hard combined anesthesia; 3. Aged 18–65 years; 4. Body mass index of 18 – 30 kg/m2; 5. Signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. A history of central nervous system diseases; 2. Hypertension or coronary artery disease or congestive heart failure; 3. Patients with degree II-III atrioventricular block or sinus bradycardia (preoperative sinus rhythm is less than 50 beats/min) or recent use of beta-blockers; 4. Patients with severe liver and kidney insufficiency (plasma albumin content should be greater than 35g/L); 5. Ventilation dysfunction such as pulmonary infection or sleep apnea syndrome; 6. Menstrual women, pregnant women, hearing impairment, elderly dementia or mental disorders unable to cooperate; 7. People who take narcotic analgesics, sedatives, antidepressants, anticonvulsants, drugs of abuse, and alcoholism in the past year; 8. People with allergies to remazolam hydrochloride, lidocaine, ropivacaine, or bupivacaine; 9. Refuse to participate and be included in the researcher.

Design outcomes

Primary

MeasureTime frame
Effect chamber transport rate constant;System execution error;

Countries

China

Contacts

Public ContactJianjin Li

Peking University Shenzhen Hospital

sex13@163.com+86 13434462088

Outcome results

None listed

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