Morbid ObesityPhase 2NCT02545595
Sugammadex Dosage Based on Ideal Body Weight for Profound Rocuronium-induced Neuromuscular Blockade Reversal in Morbidly Obese Patients
A Phase 2 study testing Sugammadex 1 mg/kg, Sugammadex 2 mg/kg and Sugammadex 4 mg/kg in people with Morbid Obesity, run by Poitiers University Hospital at 1 site in France.
Trial summary
This randomized double blind clinical trial focuses on patients with Body Masse Index ≥ 40 kg/m2, undergoing scheduled surgery. Neuromuscular transmission monitoring at the adductor is performed using. Anaesthesia is induced with anaesthesic and maintained with curare. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Sugammadex 1 mg/kg, Sugammadex 2 mg/kg and Sugammadex 4 mg/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- May 2012to Dec 2013
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General anaesthesia
- Neuromuscular blockade induce by rocuronium
- Body Masse Indice ≥ 40 kg/m2
- informed consent
Who cannot join
- Contraindication to rocuronium or sugammadex
- Pregnant women
- Severe renal insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
This randomized double blind clinical trial focuses on patients with Body Masse Index ≥ 40 kg/m2, undergoing scheduled surgery. Neuromuscular transmission monitoring at the adductor is performed using. Anaesthesia is induced with anaesthesic and maintained with curare. At the end of the procedure, patients with profound neuromuscular blockade receive either 1 mg/kg, 2 mg/kg or 4 mg/kg Sugammadex based on ideal body weight. A complete reversal failure is defined by a Train Of Four ratio < 0.9 within 10 min after administration of Sugammadex or if recurarization occurs within 15 min after complete reversal success.
- Conditions
- Morbid Obesity
- Being tested
- Sugammadex 1 mg/kg, Sugammadex 2 mg/kg, Sugammadex 4 mg/kg
- Keywords
- General anaesthesia, Curarization with rocuronium
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugammadex 1 mg/kgDrug
Sugammadex 2 mg/kgDrug
Sugammadex 4 mg/kgDrug
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex 1mg/kg | Experimental | for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients Receives: Drug: Sugammadex 1 mg/kg |
| Sugammadex 2mg/kg | Experimental | for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients Receives: Drug: Sugammadex 2 mg/kg |
| Sugammadex 4mg/kg | Experimental | for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients Receives: Drug: Sugammadex 4 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine a profound neuromuscular blockade reversal on ideal body weight
A complete reversal failure is defined by a Train Of Four ratio < 0.9 within 10 min after administration of Sugammadex or if recurarization occurs within 15 min after complete reversal success
Measured: 30 minutes
Secondary outcomes (1)
Compare dosages based on ideal body weight to real body weight
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startMay 2012
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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 2
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545595
- Sponsor's protocol ID
- OBRITI
- Status last verified
- Oct 2016
- First submitted
- 27 Mar 2013
- Last updated
- 12 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sugammadex Dosage Based on Ideal Body Weight for Profound Rocuronium-induced Neuromuscular Blockade Reversal in Morbidly Obese Patients
- ClinicalTrials.gov ID
- NCT02545595
- Acronym / sponsor ID
- OBRITI
- Conditions
- Morbid Obesity
- Keywords
- General anaesthesia, Curarization with rocuronium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2013 (actual)
- First posted
- 10 Sep 2015 (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.
This randomized double blind clinical trial focuses on patients with Body Masse Index ≥ 40 kg/m2, undergoing scheduled surgery. Neuromuscular transmission monitoring at the adductor is performed using. Anaesthesia is induced with anaesthesic and maintained with curare. At the end of the procedure, patients with profound neuromuscular blockade receive either 1 mg/kg, 2 mg/kg or 4 mg/kg Sugammadex based on ideal body weight. A complete reversal failure is defined by a Train Of Four ratio < 0.9 within 10 min after administration of Sugammadex or if recurarization occurs within 15 min after complete reversal success.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sugammadex 1mg/kg | Experimental | Drug: Sugammadex 1 mg/kgfor profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients |
| Sugammadex 2mg/kg | Experimental | Drug: Sugammadex 2 mg/kgfor profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients |
| Sugammadex 4mg/kg | Experimental | Drug: Sugammadex 4 mg/kgfor profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- General anaesthesia
- Neuromuscular blockade induce by rocuronium
- Body Masse Indice ≥ 40 kg/m2
- informed consent
Key exclusion criteria (3 listed)
- Contraindication to rocuronium or sugammadex
- Pregnant women
- Severe renal insufficiency
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 |
|---|---|---|
| Sugammadex 1 mg/kg | Drug | Sugammadex 1mg/kg |
| Sugammadex 2 mg/kg | Drug | Sugammadex 2mg/kg |
| Sugammadex 4 mg/kg | Drug | Sugammadex 4mg/kg |
Primary outcome
determine a profound neuromuscular blockade reversal on ideal body weight
Time frame: 30 minutes
A complete reversal failure is defined by a Train Of Four ratio < 0.9 within 10 min after administration of Sugammadex or if recurarization occurs within 15 min after complete reversal success
1 secondary outcome
Compare dosages based on ideal body weight to real body weight
Time frame: 30 minutes
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 12 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sugammadex 1 mg/kg, Sugammadex 2 mg/kg and Sugammadex 4 mg/kg in people with Morbid Obesity, run by Poitiers University Hospital 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 4 inclusion and 3 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 12 Oct 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
determine a profound neuromuscular blockade reversal on ideal body weight (time frame: 30 minutes). 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 12 Oct 2016.