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NCT01937767 Clinical Trial

Remimazolam Phase II Cardiac Anesthesia Study

General Anesthesia Clinical Trial

Official title:
A Randomized, Single-blind Phase II Study Evaluating the Efficacy, Safety and Pharmacokinetics of Remimazolam in General Anesthesia in Adult Patients Undergoing Cardiac Surgery, Including Follow-up Sedation in the PACU/ICU

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01937767
Other study ID # CNS7056-010
Secondary ID 2013-001113-32
Status Completed
Phase Phase 2
First received
Last updated
Start date August 2013
Est. completion date February 19, 2014

Study information
Verified date January 2020
Source Paion UK Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date February 19, 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Remimazolam

• Propofol

• Sevoflurane

• Remifentanil

• Fentanyl

• Rocuronium

Locations
Country Name City State
Germany Herzzentrum Leipzig GmbH Leipzig

Sponsors (2)
Lead Sponsor Collaborator
Paion UK Ltd. Aptiv Solutions

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients with successful anesthesia 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. Between the start of study medication and the end of the surgical procedure (up to approx 12 hours)
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