General AnesthesiaPhase 2NCT01937767
Remimazolam Phase II Cardiac Anesthesia Study
A Phase 2 study testing Remimazolam, Propofol and Sevoflurane in people with General Anesthesia, run by Paion UK Ltd. at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Remimazolam, Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2013to 19 Feb 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled for major elective cardiac surgery.
- scheduled for mechanical ventilation via tracheal intubation.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- General Anesthesia
- Being tested
- Remimazolam, Propofol, Sevoflurane, Remifentanil, Fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Also called ByFavo, Aptimyda, CNS7056
PropofolDrug
Also called Propofol-®Lipuro 10 mg/ml
SevofluraneDrug
Also called Sevofluran Baxter
RemifentanilDrug
Also called Ultiva (remifentanil hydrochloride) for Injection
FentanylDrug
Also called Fentanyl-Janssen
RocuroniumDrug
Also called Esmeron 10mg/ml solution for injection
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Induction: Propofol, fentanyl, rocuronium. Maintenance: Sevoflurane, remifentanil. Receives: Drug: Propofol; Drug: Sevoflurane; Drug: Remifentanil; Drug: Fentanyl; Drug: Rocuronium |
| Remimazolam 6 mg/kg/hr | Experimental | Induction: Remimazolam 6 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil. Receives: Drug: Remimazolam; Drug: Remifentanil; Drug: Fentanyl; Drug: Rocuronium |
| Remimazolam 12 mg/kg/hr | Experimental | Induction: Remimazolam 12 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil. Receives: Drug: Remimazolam; Drug: Remifentanil; Drug: Fentanyl; Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between the start of study medication and the end of the surgical procedure (up to approx 12 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2014
- Study completion19 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paion UK Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aptiv Solutions
- Responsible party
- Sponsor
- Investigators
- Stefan Probst, MD, Principal investigator, Heart Center Leipzig - University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937767
- Sponsor's protocol ID
- CNS7056-010
- Other IDs
- 2013-001113-32
- Status last verified
- Jan 2020
- First submitted
- 29 Aug 2013
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01937767
- Acronym / sponsor ID
- CNS7056-010
- Conditions
- General Anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Paion UK Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Aptiv Solutions
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- 19 Feb 2014 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: Propofol, Drug: Sevoflurane, Drug: Remifentanil, Drug: Fentanyl, Drug: RocuroniumInduction: Propofol, fentanyl, rocuronium. Maintenance: Sevoflurane, remifentanil. |
| Remimazolam 6 mg/kg/hr | Experimental | Drug: Remimazolam, Drug: Remifentanil, Drug: Fentanyl, Drug: RocuroniumInduction: Remimazolam 6 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil. |
| Remimazolam 12 mg/kg/hr | Experimental | Drug: Remimazolam, Drug: Remifentanil, Drug: Fentanyl, Drug: RocuroniumInduction: Remimazolam 12 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- scheduled for major elective cardiac surgery.
- scheduled for mechanical ventilation via tracheal intubation.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemimazolamAlso: ByFavo, Aptimyda, CNS7056 | Drug | Remimazolam 12 mg/kg/hr, Remimazolam 6 mg/kg/hr |
| PropofolAlso: Propofol-®Lipuro 10 mg/ml | Drug | Propofol |
| SevofluraneAlso: Sevofluran Baxter | Drug | Propofol |
| RemifentanilAlso: Ultiva (remifentanil hydrochloride) for Injection | Drug | Propofol, Remimazolam 12 mg/kg/hr, Remimazolam 6 mg/kg/hr |
| FentanylAlso: Fentanyl-Janssen | Drug | Propofol, Remimazolam 12 mg/kg/hr, Remimazolam 6 mg/kg/hr |
| RocuroniumAlso: Esmeron 10mg/ml solution for injection | Drug | Propofol, Remimazolam 12 mg/kg/hr, Remimazolam 6 mg/kg/hr |
Primary outcome
Proportion of patients with successful anesthesia
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Probst, MD principal investigator
Heart Center Leipzig - University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Remimazolam, Propofol and Sevoflurane in people with General Anesthesia, run by Paion UK Ltd. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with successful anesthesia (time frame: Between the start of study medication and the end of the surgical procedure (up to approx 12 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.