AnesthesiaPhase 4Sugammadex2NCT01579851
Recovery After Sugammadex(Propofol vs Sevoflurane)
A Phase 4 study testing Sugammadex in people with Anesthesia, run by Hopital Foch at 1 site in France.
Trial summary
Sugammadex is used to reverse of a neuro-muscular block deep. It has been reported that its administration could induce signs of recovery despite continuation of anesthetic drugs. The goal of the present study is to look is the arte of this event is different according to the primary anesthetic agent used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Sugammadex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Jan 2015
- Phase
- Phase 4
- 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
- adult patients scheduled to receive general anesthesia with muscle relaxation achieved with rocuronium
Who cannot join
- Known drug allergy,
- Contra-indications to the use of propofol, remifentanil, rocuronium, sevoflurane, sugammadex
- Difficulty to use Bispectral Index monitor
- Inability to obtain a proper monitoring of muscle relaxation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recovery After Sugammadex(TIVA Using Propofol vs Inhalation Anesthesia Using Sevoflurane)
Sugammadex is used to reverse of a neuro-muscular block deep. It has been reported that its administration could induce signs of recovery despite continuation of anesthetic drugs. The goal of the present study is to look is the arte of this event is different according to the primary anesthetic agent used.
- Conditions
- Anesthesia
- Being tested
- Sugammadex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
sugammadex
- 4 mg/kg : if there is no response to Train of Four stimulations and at least one response to the Post Tetanic Count
- 2 mg/kg : if there is at least two responses to Train of Four stimulations
| Study group | Role | What they receive |
|---|---|---|
| Propofol-Remifentanil | Active comparator | Anesthesia is maintained with Propofol and Remifentanil; myorelaxation is obtained with rocuronium Receives: Drug: Sugammadex |
| Sevoflurane-Remifentanil | Active comparator | Anesthesia is maintained with Sevoflurane and Remifentanil; myorelaxation is obtained with rocuronium Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with an increase in Bispectral Index after sugammadex injection
Increase in Bispectral Index (> 20) after sugammadex injection
Measured: One hour after anesthesia
Number of patients with occurence of clinical signs of awakening after sugammadex injection
Clinical signs of awakening after sugammadex are wallowing, eye opening on demand, cough, spontaneous movements, response to simple commands, tearing, ...
Measured: One hour after anesthesia
Secondary outcomes (2)
T4/T1 ratio after sugammadex injection
Modification of T4/T1 ratio after sugammadex injection
Measured: One hour after anesthesia
Number of patients with side effects due to sugammadex injection
Side effects after sugammadex injection are bradycardia, nausea or vomiting, pain, residual curarisation, awareness,...
Measured: One hour after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2015
- Study completionJan 2015
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan Le Guen, MD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579851
- Sponsor's protocol ID
- 2010/58
- Other IDs
- 2010-023943-13
- Acronym
- Sugammadex2
- Status last verified
- May 2017
- First submitted
- 4 Jan 2012
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery After Sugammadex(TIVA Using Propofol vs Inhalation Anesthesia Using Sevoflurane)
- ClinicalTrials.gov ID
- NCT01579851
- Acronym / sponsor ID
- Sugammadex2 / 2010/58
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 Apr 2012 (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.
Sugammadex is used to reverse of a neuro-muscular block deep. It has been reported that its administration could induce signs of recovery despite continuation of anesthetic drugs. The goal of the present study is to look is the arte of this event is different according to the primary anesthetic agent used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol-Remifentanil | Active comparator | Drug: SugammadexAnesthesia is maintained with Propofol and Remifentanil; myorelaxation is obtained with rocuronium |
| Sevoflurane-Remifentanil | Active comparator | Drug: SugammadexAnesthesia is maintained with Sevoflurane and Remifentanil; myorelaxation is obtained with rocuronium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients scheduled to receive general anesthesia with muscle relaxation achieved with rocuronium
Key exclusion criteria (4 listed)
- Known drug allergy,
- Contra-indications to the use of propofol, remifentanil, rocuronium, sevoflurane, sugammadex
- Difficulty to use Bispectral Index monitor
- Inability to obtain a proper monitoring of muscle relaxation.
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 |
|---|---|---|
| Sugammadexsugammadex * 4 mg/kg : if there is no response to Train of Four stimulations and at least one response to the Post Tetanic Count * 2 mg/kg : if there is at least two responses to Train of Four stimulations | Drug | Propofol-Remifentanil, Sevoflurane-Remifentanil |
Primary outcome
Number of patients with an increase in Bispectral Index after sugammadex injection
Time frame: One hour after anesthesia
Increase in Bispectral Index (> 20) after sugammadex injection
Number of patients with occurence of clinical signs of awakening after sugammadex injection
Time frame: One hour after anesthesia
Clinical signs of awakening after sugammadex are wallowing, eye opening on demand, cough, spontaneous movements, response to simple commands, tearing, ...
2 secondary outcomes
T4/T1 ratio after sugammadex injection
Time frame: One hour after anesthesia
Number of patients with side effects due to sugammadex injection
Time frame: One hour after 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 22 May 2017.
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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.
Morgan Le Guen, MD principal investigator
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 4 study testing Sugammadex 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 4 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 22 May 2017. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Number of patients with an increase in Bispectral Index after sugammadex injection (time frame: One hour after anesthesia). The study lists 2 primary outcomes in all. 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 22 May 2017.