AnesthesiaPhase 3NCT00922467
Influence of Esmolol on a Closed-Loop Anesthesia System
A Phase 3 study testing NaCl 9/00 and Esmolol in people with Anesthesia, run by Hopital Foch at 1 site in France.
Trial summary
Main objective is to evaluate the sparing effect of esmolol on the required doses of propofol and remifentanil Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Anesthesia
- What is being tested?
- NaCl 9/00 and Esmolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to Dec 2011
- Phase
- Phase 3
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male patients scheduled for a general anesthesia
Who cannot join
- age lower than 18 years
- allergy to propofol, or to soja or to peanuts, or to sufentanil, to remifentanil, or to morphine, or to a myorelaxant or to an excipient,
- any other history of anaphylactic reaction,
- hypersensibility to sufentanil, or to remifentanil, or to other derivate of fentanyl,
- hypersensibility to esmolol or to an excipient,
- history of central nervous system disease,
Show all 15Show fewer
- patients receiving a psychotropic treatment or an agonist-antagonist opiate,
- hypovolemic patients,
- patients receiving a cardio-vascular treatment,
- patients with a pacemaker,
- expected bleeding more than 20% of the blood volume,
- simultaneous general and loco-regional anesthesia,
- patients suffering from asthma, COPD, trouble of the heart rhythm or conduction, cardiac insufficiency, cardiogenogenic shock, Prinzmetal syndrome, pheochromocytoma,
- patients with a heart rate less than 50/min and/or an arterial hypotension,
- neurosurgical act or any other which precludes an adequate positioning of the bispectral electrode.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Closed-loop Delivery of Propofol and Remifentanil: Sparing Effect of Esmolol
Main objective is to evaluate the sparing effect of esmolol on the required doses of propofol and remifentanil
- Conditions
- Anesthesia
- Being tested
- NaCl 9/00, Esmolol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaCl 9/00Drug
Same volume as in the esmolol group
EsmololDrug
1 mg/kg administrated over 10 minutes followed by an infusion of 0,2 mg/kg/hr during all the anesthetic period
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo Receives: Drug: NaCl 9/00 |
| Esmolol | Experimental | patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and esmolol Receives: Drug: Esmolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
administered doses of propofol and of remifentanil during anesthesia
Measured: end of anesthesia
Secondary outcomes (4)
delay before recovery
Measured: at the end of anesthesia
hemodynamic abnormalities requiring a treatment
Measured: end of anesthesia
postoperative morphine requirement
Measured: Third post-anesthetic hour
explicit memorisation
Measured: Second postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2009
- Study completionDec 2011
Why it stopped: lack of effectiveness
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, MD, Study chair, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922467
- Sponsor's protocol ID
- 2008/47
- Status last verified
- Sep 2016
- First submitted
- 2 Jun 2009
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed-loop Delivery of Propofol and Remifentanil: Sparing Effect of Esmolol
- ClinicalTrials.gov ID
- NCT00922467
- Acronym / sponsor ID
- 2008/47
- Conditions
- Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of effectiveness
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Jun 2009 (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.
Main objective is to evaluate the sparing effect of esmolol on the required doses of propofol and remifentanil
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: NaCl 9/00patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo |
| Esmolol | Experimental | Drug: Esmololpatients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and esmolol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- male patients scheduled for a general anesthesia
Key exclusion criteria (15 listed)
- age lower than 18 years
- allergy to propofol, or to soja or to peanuts, or to sufentanil, to remifentanil, or to morphine, or to a myorelaxant or to an excipient,
- any other history of anaphylactic reaction,
- hypersensibility to sufentanil, or to remifentanil, or to other derivate of fentanyl,
- hypersensibility to esmolol or to an excipient,
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 |
|---|---|---|
| NaCl 9/00Same volume as in the esmolol group | Drug | Placebo |
| Esmolol1 mg/kg administrated over 10 minutes followed by an infusion of 0,2 mg/kg/hr during all the anesthetic period | Drug | Esmolol |
Primary outcome
administered doses of propofol and of remifentanil during anesthesia
Time frame: end of anesthesia
4 secondary outcomes
delay before recovery
Time frame: at the end of anesthesia
hemodynamic abnormalities requiring a treatment
Time frame: end of anesthesia
postoperative morphine requirement
Time frame: Third post-anesthetic hour
explicit memorisation
Time frame: Second postoperative day
Results and safety
The study was stopped early (reason given: lack of effectiveness). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
Related trials for Anesthesia
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Not yet recruitingPhase 4
Propofol Target-Controlled Infusion Versus Dexmedetomidine for Sedation During Chronic Subdural Hematoma Surgery Under Local Anesthesia
Chronic Subdural Hematoma
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
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.
Marc Fischler, MD study chair
Hôpital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NaCl 9/00 and Esmolol in people with Anesthesia, run by Hopital Foch at 1 site in France.
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 1 inclusion and 15 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: stopped early, as of the sponsor's last update on 23 Sep 2016. 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 France. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: lack of effectiveness). Results are not available in the source record.
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?
administered doses of propofol and of remifentanil during anesthesia (time frame: end of anesthesia). 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 23 Sep 2016.