Not Yet RecruitingEarly Phase 1

The Efficacy and Safety of Remimazolam Besylate for Cardiac Anesthesia

320 participantsStarted 2025-01

Plain-language summary

The evidence on the practice of remimazolam besylate during cardiac anesthesia is scarce. This study investigates the efficacy and safety of remimazolam besylate general induction and maintenance during cardiac surgery.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Elective cardiac surgery via cardiopulmonary bypass;
✓. Aged 18-65 years;
✓. American Society of Anesthesiologists (ASA) grade I-III;
✓. Body mass index (BMI) 18-28 kg/m2.

Exclusion criteria

✕. A history of sternotomy for heart disease;
✕. Angina or arrhythmia with severe dynamics flutters pre-operation;
✕. Respiratory, hepatic or renal dysfunction (oxygenation index\<300, alanine transaminase\> 2 upper limits of normal value, creatinine \> 200 μmol/L);
✕. Diagnosed with advanced tumors;
✕. Psychiatric or mental disorders;
✕. Myasthenia gravis or seizures;
✕. Pregnant or lactating females;
✕. A history of benzodiazepines administration within 3 months before surgery;

What they're measuring

ratio of successful sedation during the whole surgery

Timeframe: Intraoperative period

Trial details

NCT IDNCT06717945

SponsorChinese Academy of Medical Sciences, Fuwai Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05

View on ClinicalTrials.gov More Anesthesia trials