The Efficacy and Safety of Remimazolam Besylate for Cardiac Anesthesia

ConditionAnesthesia
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChinese Academy of Medical Sciences, Fuwai Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • remimazolam besylate

    Drug

    Patients received an initial dose of remimazolam (0.3mg/kg) for induction and a continuous infusion rate of 1 mg/kg/h for anesthesia maintenance. Sedative was adjusted to maintain a bispectral index (BIS) at 40-60 after induction.

  • propofol

    Drug

    Patients received an initial dose of propofol (1.0 mg/kg) and a continuous infusion rate of 1-1.5 mg/kg/h. Sedative was adjusted to maintain a bispectral index (BIS) at 40-60 after induction.

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: remimazolam besylateExperimental treatment 1 intervention
Group B: propofolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

ratio of successful sedation during the whole surgery

Sedation success is defined as BIS locating in the range of 40-60 according to the required dosage without additional rescue sedative during the surgical procedures.

Time frame
Intraoperative period

Secondary outcomes

1

time interval for BIS from baseline before induction to 60

Time frame
Intraoperative period

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: