AnesthesiaPhase 3NCT00921284
Influence of Dexmedetomidine on a Closed-Loop Anesthesia System
A Phase 3 study testing NaCl 9/00 and dexmedetomidine in people with Anesthesia, run by Hopital Foch at 1 site in France.
Trial summary
The main objective if to evaluate the sparing effect of dexmedetomidine on the 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 dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to Jul 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,
- hypersensibility to sufentanil, or to remifentanil, or to other derivate of fentanyl,
- history of central nervous system disease,
- patients receiving a psychotropic treatment or an agonist-antagonist opiate,
- hypovolemic patients,
Show all 10Show fewer
- patients receiving a cardio-vascular treatment,
- expected bleeding surgical procedure,
- simultaneous general and loco-regional anesthesia,
- severe hepatic insufficiency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Closed-Loop Delivery of Propofol and Remifentanil: Sparing Effect of Dexmedetomidine
The main objective if to evaluate the sparing effect of dexmedetomidine on the doses of propofol and remifentanil.
- Conditions
- Anesthesia
- Being tested
- NaCl 9/00, dexmedetomidine
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 dexmedetomidine group
dexmedetomidineDrug
1 mcg/kg administered in 10 minutes followed by a continuous infusion of 0,5 mcg/kg/hr
| 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 |
| dexmedetomidine | Experimental | patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and dexmedetomidine Receives: Drug: dexmedetomidine |
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 posted16 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2011
- Study completionJul 2011
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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, MD, Study chair, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921284
- Sponsor's protocol ID
- 2008/41
- Status last verified
- Sep 2016
- First submitted
- 13 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 Dexmedetomidine
- ClinicalTrials.gov ID
- NCT00921284
- Acronym / sponsor ID
- 2008/41
- Conditions
- Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 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.
The main objective if to evaluate the sparing effect of dexmedetomidine on the 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 |
| dexmedetomidine | Experimental | Drug: dexmedetomidinepatients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and dexmedetomidine |
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 (10 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,
- hypersensibility to sufentanil, or to remifentanil, or to other derivate of fentanyl,
- history of central nervous system disease,
- patients receiving a psychotropic treatment or an agonist-antagonist opiate,
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 dexmedetomidine group | Drug | Placebo |
| dexmedetomidine1 mcg/kg administered in 10 minutes followed by a continuous infusion of 0,5 mcg/kg/hr | Drug | dexmedetomidine |
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 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 23 Sep 2016.
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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.
Marc Fischler, MD study chair
Hopital 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 dexmedetomidine 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 10 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 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 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?
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.