Neuromuscular BlockadePhase 3SugReBaCh-1NCT01570179
Sugammadex-dosing in Bariatric Patients
A Phase 3 study testing ideal BW based sugammadex reversal of moderate block, real body weight based sugammadex reversal of moderate block and real body weight based sugammadex reversal of deep block in people with Neuromuscular Blockade, run by Central Hospital, Nancy, France at 2 sites in France.
Trial summary
Should the dose of sugammadex in morbid obese patients be calculated on the real body weight or the ideal body weight? The main objective of the trial is to compare in patients undergoing bariatric surgery the efficacy of sugammadex to obtain a TOF-ratio of 100% within 3 min when dosing is based on real body weight… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- ideal BW based sugammadex reversal of moderate block, real body weight based sugammadex reversal of moderate block and real body weight based sugammadex reversal of deep block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesFrance
- Study dates
- May 2012to Jul 2012
- 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
- adult patients undergoing bariatric surgery according to the respective criteria of the French Medical Authority (HAS) and having given their written informed consent after appropriate information
Who cannot join
- not fulfilling the inclusion criteria, known or suspected allergy to any of the drugs used in that study, absence of written informed consent,doubt of pregnancy in women of childbearing age, pregnancy and breast feeding
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Strasbourg Hôpital Civil
Strasbourg, Alsace, 67091
CHU Nancy
Vandœuvre-lès-Nancy, Lorraine, 54500
About this study
Official title: Sugammadex in Patients Undergoing Bariatric Surgery: An Equivalence Trial Comparing Real and Ideal Body Weight-based Dosing
Should the dose of sugammadex in morbid obese patients be calculated on the real body weight or the ideal body weight?
The main objective of the trial is to compare in patients undergoing bariatric surgery the efficacy of sugammadex to obtain a TOF-ratio of 100% within 3 min when dosing is based on real body weight (control intervention) with dosing based on ideal body weight (experimental intervention). The research hypothesis is that both dosing regimens are equivalent
The secondary objective of the trial is to compare the impact of the depth of neuromuscular blockade on the surgical conditions: deep block (TOF-count 1 - 3) will be compared with very deep block (TOF count = 0 and PTC < 5)
- Conditions
- Neuromuscular Blockade
- Being tested
- ideal BW based sugammadex reversal of moderate block, real body weight based sugammadex reversal of moderate block, real body weight based sugammadex reversal of deep block, ideal body weight based sugammadex reversal of deep block
- Keywords
- bariatric surgery, residual paralysis, surgical conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ideal BW based sugammadex reversal of moderate blockDrug
2 mg/kg sugammadex (based og ideal body weight)
real body weight based sugammadex reversal of moderate blockDrug
2 mg/kg sugammadex (based on real BW)
real body weight based sugammadex reversal of deep blockDrug
4 mg/kg sugammadex (based on real BW)
ideal body weight based sugammadex reversal of deep blockDrug
4 mg/kg sugammadex (based on ideal BW)
| Study group | Role | What they receive |
|---|---|---|
| deep block ideal body weight | Experimental | Not described Receives: Drug: ideal body weight based sugammadex reversal of deep block |
| deep block real body weight | Active comparator | Not described Receives: Drug: real body weight based sugammadex reversal of deep block |
| moderate block ideal body weight | Experimental | Not described Receives: Drug: ideal BW based sugammadex reversal of moderate block |
| moderate block real body weight | Active comparator | Not described Receives: Drug: real body weight based sugammadex reversal of moderate block |
What is being measured
The primary outcome is the main question the study is designed to answer.
100% TOF-recovery 3 min after sugammadex
Measured: 3 min
Secondary outcomes (1)
impact of depth of block on surgical conditions
to evaluate the impact of neuromuscular blockade on surgical conditions, the The "King Score" (King M, Anesthesiology 2000; 93:1392 - 7) will be applied every 15 min throught surgery by the surgeon (blinded to the study protocol)King-Score: from 1 to 4 with 1 excellent conditions, 2 good conditions, 3 acceptable conditions and 4 poor conditions.
Measured: every 15 min during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570179
- Sponsor's protocol ID
- 2011-005504-14
- Acronym
- SugReBaCh-1
- Status last verified
- Jan 2013
- First submitted
- 27 Mar 2012
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sugammadex in Patients Undergoing Bariatric Surgery: An Equivalence Trial Comparing Real and Ideal Body Weight-based Dosing
- ClinicalTrials.gov ID
- NCT01570179
- Acronym / sponsor ID
- SugReBaCh-1 / 2011-005504-14
- Conditions
- Neuromuscular Blockade
- Keywords
- bariatric surgery, residual paralysis, surgical conditions
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 4 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.
Should the dose of sugammadex in morbid obese patients be calculated on the real body weight or the ideal body weight?
The main objective of the trial is to compare in patients undergoing bariatric surgery the efficacy of sugammadex to obtain a TOF-ratio of 100% within 3 min when dosing is based on real body weight (control intervention) with dosing based on ideal body weight (experimental intervention). The research hypothesis is that both dosing regimens are equivalent
The secondary objective of the trial is to compare the impact of the depth of neuromuscular blockade on the surgical conditions: deep block (TOF-count 1 - 3) will be compared with very deep block (TOF count = 0 and PTC < 5)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| deep block ideal body weight | Experimental | Drug: ideal body weight based sugammadex reversal of deep block |
| deep block real body weight | Active comparator | Drug: real body weight based sugammadex reversal of deep block |
| moderate block ideal body weight | Experimental | Drug: ideal BW based sugammadex reversal of moderate block |
| moderate block real body weight | Active comparator | Drug: real body weight based sugammadex reversal of moderate block |
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 undergoing bariatric surgery according to the respective criteria of the French Medical Authority (HAS) and having given their written informed consent after appropriate information
Key exclusion criteria (1 listed)
- not fulfilling the inclusion criteria, known or suspected allergy to any of the drugs used in that study, absence of written informed consent,doubt of pregnancy in women of childbearing age, pregnancy and breast feeding
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 |
|---|---|---|
| ideal BW based sugammadex reversal of moderate block2 mg/kg sugammadex (based og ideal body weight) | Drug | moderate block ideal body weight |
| real body weight based sugammadex reversal of moderate block2 mg/kg sugammadex (based on real BW) | Drug | moderate block real body weight |
| real body weight based sugammadex reversal of deep block4 mg/kg sugammadex (based on real BW) | Drug | deep block real body weight |
| ideal body weight based sugammadex reversal of deep block4 mg/kg sugammadex (based on ideal BW) | Drug | deep block ideal body weight |
Primary outcome
100% TOF-recovery 3 min after sugammadex
Time frame: 3 min
1 secondary outcome
impact of depth of block on surgical conditions
Time frame: every 15 min during surgery
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 24 Jan 2013.
Related trials for Neuromuscular Blockade
Not yet recruiting
Comparative Effects Of Exercises Targeting Upper Trapezius In Patients With Non Specific Neck Pain
Non Specific Neck Pain
RecruitingObservational study
The Association Between Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio
Muscle Relaxants
Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 ideal BW based sugammadex reversal of moderate block, real body weight based sugammadex reversal of moderate block and real body weight based sugammadex reversal of deep block in people with Neuromuscular Blockade, run by Central Hospital, Nancy, France at 2 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 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 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
100% TOF-recovery 3 min after sugammadex (time frame: 3 min). 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 24 Jan 2013.