Remimazolam Phase II Cardiac Anesthesia Study

Phase 2

Completed

• Conditions: General Anesthesia
• Interventions: Drug: Propofol; Drug: Remimazolam; Drug: Remifentanil; Drug: Sevoflurane; Drug: Fentanyl; Drug: Rocuronium

• Registration Number: NCT01937767
• Lead Sponsor: Paion UK Ltd.

Brief Summary

This phase II study in patients undergoing elective cardiac surgery will evaluate the efficacy, safety, and pharmacokinetics of remimazolam, compared with propofol and sevoflurane, during the induction and maintenance of general anesthesia.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-29
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-10
• Primary Completion: 2014-02
• Study Completion: 2014-02-19
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-15
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• scheduled for major elective cardiac surgery.
• scheduled for mechanical ventilation via tracheal intubation.

Exclusion Criteria

• thoraco-abdominal replacement of the aorta or other procedure expected to be accompanied by a massive hemorrhage (at least 15% of the circulating blood volume).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam 6 mg/kg/hr	Remifentanil	Induction: Remimazolam 6 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.
Propofol	Sevoflurane	Induction: Propofol, fentanyl, rocuronium. Maintenance: Sevoflurane, remifentanil.
Propofol	Propofol	Induction: Propofol, fentanyl, rocuronium. Maintenance: Sevoflurane, remifentanil.
Propofol	Fentanyl	Induction: Propofol, fentanyl, rocuronium. Maintenance: Sevoflurane, remifentanil.
Propofol	Remifentanil	Induction: Propofol, fentanyl, rocuronium. Maintenance: Sevoflurane, remifentanil.
Remimazolam 6 mg/kg/hr	Fentanyl	Induction: Remimazolam 6 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.
Remimazolam 6 mg/kg/hr	Remimazolam	Induction: Remimazolam 6 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.
Propofol	Rocuronium	Induction: Propofol, fentanyl, rocuronium. Maintenance: Sevoflurane, remifentanil.
Remimazolam 6 mg/kg/hr	Rocuronium	Induction: Remimazolam 6 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.
Remimazolam 12 mg/kg/hr	Remimazolam	Induction: Remimazolam 12 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.
Remimazolam 12 mg/kg/hr	Remifentanil	Induction: Remimazolam 12 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.
Remimazolam 12 mg/kg/hr	Fentanyl	Induction: Remimazolam 12 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.
Remimazolam 12 mg/kg/hr	Rocuronium	Induction: Remimazolam 12 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with successful anesthesia	Between the start of study medication and the end of the surgical procedure (up to approx 12 hours)	Successful anesthesia was defined as no use of rescue sedative medication between start of the study medication and end of the surgical procedure completion of last skin suture.

Trial Locations

Locations (1)

Herzzentrum Leipzig GmbH; 🇩🇪 Leipzig, Germany