Anesthesia, GeneralPhase 3Drone-CurareNCT00886418
Influence of Muscle Relaxation on a Closed-loop Anesthesia System
A Phase 3 study testing muscle relaxant and normal saline in people with Anesthesia, General, run by Hopital Foch at 3 sites in France.
Trial summary
Total intra-venous anesthesia can be provided using a closed-loop system guided by the bispectral index. The purpose of this study is to determine if myorelaxation modifies its functioning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- muscle relaxant and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 3 sitesFrance
- Study dates
- Dec 2009to Feb 2015
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for a surgical procedure which not require a myorelaxation
Who cannot join
- age less than 18 years,
- ASA III and above,
- pregnant woman
- combined general and regional anesthesia,
- history of prolonged myorelaxation due to a decrease in cholinesterase,
- patient with a known lack in cholinesterase,
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- history of cerebral or psychiatric central,
- allergy to latex, propofol, remifentanil, morphine, muscle relaxant or any of the excipients,
- known hypersensitivity to remifentanil or to an other derivative of fentanyl,
- presence of a pacemaker,
- psychotropic or agonist-antagonist morphine treatment,
- planned post-operative sedation.
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Besançon
Besançon, 25000
Institut Paoli-Calmette
Marseille, 13273
Hôpital Foch
Suresnes, 92151
About this study
Official title: Effect of Continuous Myorelaxation on the Need for Hypnotic Agent During Surgical Procedures Which do Not Require it (Multicenter, Randomized and Prospective Study)
Total intra-venous anesthesia can be provided using a closed-loop system guided by the bispectral index. The purpose of this study is to determine if myorelaxation modifies its functioning.
- Conditions
- Anesthesia, General
- Being tested
- muscle relaxant, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle relaxantDrug
muscle relaxant administration throughout anesthesia
normal salineDrug
no muscle relaxant throughout anesthesia (normal saline infused as a placebo)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Total intravenous anesthesia (propofol and remifentanil) is provided using the close-loop system. A muscle relaxant is used to facilitate tracheal intubation; its administration is continued throughout anesthesia. Receives: Drug: muscle relaxant |
| 2 | Experimental | Total intravenous anesthesia (propofol and remifentanil) is provided using the close-loop system. No muscle relaxant is used and a placebo is infused throughout anesthesia. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
propofol dose
Measured: one hour anesthesia
Secondary outcomes (7)
remifentanil dose
Measured: one hour anesthesia
number of automatic modifications of the propofol and remifentanil concentrations
Measured: one hour anesthesia
number of patients' movements
Measured: one hour anesthesia
number of hemodynamic abnormalities requiring treatment
Measured: one hour anesthesia
time to wake up
Measured: end of anesthesia
intraoperative awareness
Measured: postoperative day 1 or 2
performance of the closed-loop system
Measured: one hour anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startDec 2009
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 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
- NCT00886418
- Sponsor's protocol ID
- 2008/28
- Acronym
- Drone-Curare
- Status last verified
- Sep 2016
- First submitted
- 19 Apr 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
- Effect of Continuous Myorelaxation on the Need for Hypnotic Agent During Surgical Procedures Which do Not Require it (Multicenter, Randomized and Prospective Study)
- ClinicalTrials.gov ID
- NCT00886418
- Acronym / sponsor ID
- Drone-Curare / 2008/28
- Conditions
- Anesthesia, General
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 23 Apr 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.
Total intra-venous anesthesia can be provided using a closed-loop system guided by the bispectral index. The purpose of this study is to determine if myorelaxation modifies its functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: muscle relaxantTotal intravenous anesthesia (propofol and remifentanil) is provided using the close-loop system. A muscle relaxant is used to facilitate tracheal intubation; its administration is continued throughout anesthesia. |
| 2 | Experimental | Drug: normal salineTotal intravenous anesthesia (propofol and remifentanil) is provided using the close-loop system. No muscle relaxant is used and a placebo is infused throughout anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled for a surgical procedure which not require a myorelaxation
Key exclusion criteria (12 listed)
- age less than 18 years,
- ASA III and above,
- pregnant woman
- combined general and regional anesthesia,
- history of prolonged myorelaxation due to a decrease in cholinesterase,
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 |
|---|---|---|
| muscle relaxantmuscle relaxant administration throughout anesthesia | Drug | 1 |
| normal salineno muscle relaxant throughout anesthesia (normal saline infused as a placebo) | Drug | 2 |
Primary outcome
propofol dose
Time frame: one hour anesthesia
7 secondary outcomes
remifentanil dose
Time frame: one hour anesthesia
number of automatic modifications of the propofol and remifentanil concentrations
Time frame: one hour anesthesia
number of patients' movements
Time frame: one hour anesthesia
number of hemodynamic abnormalities requiring treatment
Time frame: one hour anesthesia
time to wake up
Time frame: end of anesthesia
intraoperative awareness
Time frame: postoperative day 1 or 2
performance of the closed-loop system
Time frame: one hour anesthesia
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
Hôpital Foch
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing muscle relaxant and normal saline in people with Anesthesia, General, run by Hopital Foch at 3 sites 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 12 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 3 sites 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. 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?
propofol dose (time frame: one hour 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.