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Efficacy and Safety of Remimazolam Besylate Combined with Fospropofol Disodium for Induction and Maintenance of General Anesthesia: A Randomized, Double-Blind, Controlled Study

Efficacy and Safety of Remimazolam Besylate Combined with Fospropofol Disodium for Induction and Maintenance of General Anesthesia: A Randomized, Double-Blind, Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111130
Enrollment
Unknown
Registered
2025-10-27
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

A patient under general anesthesia

Interventions

Experimental group1:Induction phase: Administer remimazolam besylate 0.3 mg/kg IV bolus, with supplemental doses of 0.05 mg/kg as needed. Combine with sufentanil (0.2–0.4 µg/kg) and rocuronium (1 mg/k
Experimental group2:Induction: Remazolam 0.3 mg/kg is administered intravenously, with a 0.05 mg/kg dose added if necessary. Combined with sufentanil (0.2–0.4 µg/kg) and rocuronium bromide (1 mg/kg),
Experimental group3:Induction phase: Administer remimazolam besylate 0.3 mg/kg IV bolus, with supplemental doses of 0.05 mg/kg as needed. Combine with sufentanil (0.2–0.4 µg/kg) and rocuronium (1 mg/k

Sponsors

Suzhou Ninth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Aged 18-65 years, with no gender restrictions; (2) Anesthesia Society of America (ASA) grade I to III; (3) Body mass index (BMI) between 18.5 and 30 kg/m²; (4) Scheduled for elective general anesthesia surgery with an estimated duration exceeding 30 minutes; (5) Participants voluntarily agree to participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Contraindications to general anesthesia or a history of adverse reactions to anesthesia; (2) Presence of traumatic brain injury, increased intracranial pressure, stroke, unstable angina, or myocardial infarction; (3) Respiratory insufficiency, obstructive pulmonary disease, difficult airway, or a modified Mallampati score of class III or IV; (4) Poorly controlled diabetes mellitus or hypertension; (5) History of drug abuse, alcoholism, or substance dependence; (6) Abuse or long-term use of analgesics, sedatives, or anesthetics; (7) Known or suspected allergy or contraindication to any component of the study drugs or related medications used in the procedures; (8) History of psychiatric disorders; (9) Participation in other clinical trials within 1 month prior to screening; (10) Pregnant or lactating women; women of childbearing potential and men who are unwilling to use effective contraception; (11) Any other condition deemed by the investigator to be inappropriate for participation in this study.

Design outcomes

Primary

MeasureTime frame
Anesthesia induction and maintenance success rate;

Secondary

MeasureTime frame
Total fentanyl dose;Frequency of use of vasoactive drugs during surgery;Time to open your eyes;Wake-up time;PACU residence time ;Length of hospital stay after surgery;Adverse reaction incidence;

Countries

China

Contacts

Public ContactChao Zhang

Suzhou Ninth People's Hospital

tony1345@163.com+86 188 6256 8088

Outcome results

None listed

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