Morbidly Obese PatientsPhase 2BRIDIONNCT01911520
Dose Finding Study for Effective Reversal of a Deep Rocuronium-induced Neuromuscular Block With Sugammadex in Morbidly Obese Patients
A Phase 2 study testing Sugammadex 2 mg/kg, Sugammadex. 4 mg/kg and Neuromuscular monitoring. in people with Morbidly Obese Patients, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
During laparoscopic bariatric surgery, adequate muscle relaxation is important to maintain good surgical conditions. To achieve this muscle relaxation, neuromuscular transmission blocking agents, such as rocuronium (Esmeron®) are used. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbidly Obese Patients
- What is being tested?
- Sugammadex 2 mg/kg, Sugammadex. 4 mg/kg and Neuromuscular monitoring.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to Jun 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II-III
- Age 18 - 65 year
- Male or female
- BMI > 30
Who cannot join
- Renal failure
- Liver dysfunction
- Breastfeeding female patients, or female patients without reliable contraception
- Neuromuscular disease
- Malignant hyperthermia or a family history of malignant hyperthermia
- Allergy for neuromuscular blocking agents or other medications used during general anesthesia
- Infectious disease or patients with fever
- Patients who already received rocuronium or sugammadex on the day of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Finding Study for Effective Reversal of a Deep Rocuronium-induced Neuromuscular Block With Sugammadex in Morbidly Obese Patients.
During laparoscopic bariatric surgery, adequate muscle relaxation is important to maintain good surgical conditions. To achieve this muscle relaxation, neuromuscular transmission blocking agents, such as rocuronium (Esmeron®) are used. It sometimes happens that there is still some neuromuscular blocking activity left in the patient on awakening from anesthesia. This is called residual curarization and is known to cause postoperative complications such as impairment of respiratory function.
Sugammadex (Bridion®) is a novel drug which selectively binds rocuronium (Esmeron®). It allows for reversing of neuromuscular transmission blocking activity. Until now, all studies with sugammadex were performed in non-obese patients.
Read more
Obese patient have a high risk to suffer from post-operative respiratory failure. Therefore it is vital to avoid residual curarization. Sugammadex might be an important factor.
Obese patients have a large total body weight different from ideal body weight. Recent research demonstrated that the dose for the neuromuscular blocking agent rocuronium (Esmeron®) needs to be calculated on the patients' Ideal Body Weight rather than on Total Body Weight.
At this moment no data is available on the dose-response relationship of sugammadex in morbidly obese patients.
We hypothesize that in morbidly obese patients sugammadex should be dosed on ideal bodyweight, instead of total bodyweight.
Read the detailed description
Flowchart :
72 participants
Stratification
BMI<50 BMI >50
Randomization Randomization
TBW IBW TBW IBW
2mg/kg n=9 2mg/kg n=9 2mg/kg n=9 2mg/kg n=9 4mg/kg n=9 4mg/kg n=9 4mg/kg n=9 4mg/kg n=9
TBW : Total Body Weight IBW : Ideal Body Weight
- Conditions
- Morbidly Obese Patients
- Being tested
- Sugammadex 2 mg/kg, Sugammadex. 4 mg/kg, Neuromuscular monitoring., Clinical evaluation of residual curarization .
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugammadex 2 mg/kgDrug
Patients receive 2 mg/kg Sugammadex.
Sugammadex. 4 mg/kgDrug
Patients receive 4 mg/kg Sugammadex.
Neuromuscular monitoring.Procedure or surgery
Neuromuscular monitoring using a TOF watch SX (Organon).
Clinical evaluation of residual curarization .Procedure or surgery
Every 30 min, during the first 2 hours after the end of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| BMI < 50, Total Body Weight (TBW), 2mg/kg | Experimental | Patients with a BMI < 50, who will be dosed according to total body weight. Receives: Drug: Sugammadex 2 mg/kg; Procedure: Neuromuscular monitoring.; Procedure: Clinical evaluation of residual curarization . |
| BMI < 50, TBW, 4 mg/kg | Experimental | Patients with a BMI < 50, who will be dosed according to total body weight. Receives: Drug: Sugammadex. 4 mg/kg; Procedure: Neuromuscular monitoring.; Procedure: Clinical evaluation of residual curarization . |
| BMI < 50, Ideal Body Weight (IBW), 2 mg/kg | Experimental | Patients with a BMI < 50, who will be dosed according to ideal body weight. Receives: Drug: Sugammadex 2 mg/kg; Procedure: Neuromuscular monitoring.; Procedure: Clinical evaluation of residual curarization . |
| BMI < 50, IBW, 4 mg/kg | Experimental | Patients with a BMI < 50, who will be dosed according to ideal body weight. Receives: Drug: Sugammadex. 4 mg/kg; Procedure: Neuromuscular monitoring.; Procedure: Clinical evaluation of residual curarization . |
| BMI > 50, TBW, 2mg/kg | Experimental | Patients with a BMI > 50, who will be dosed according to total body weight. Receives: Drug: Sugammadex 2 mg/kg; Procedure: Neuromuscular monitoring.; Procedure: Clinical evaluation of residual curarization . |
| BMI > 50, TBW, 4mg/kg | Experimental | Patients with a BMI > 50, who will be dosed according to total body weight. Receives: Drug: Sugammadex. 4 mg/kg; Procedure: Neuromuscular monitoring.; Procedure: Clinical evaluation of residual curarization . |
| BMI >50, IBW, 2 mg/kg | Experimental | Patients with a BMI > 50, who will be dosed according to ideal body weight. Receives: Drug: Sugammadex 2 mg/kg; Procedure: Neuromuscular monitoring.; Procedure: Clinical evaluation of residual curarization . |
| BMI >50, IBW, 4 mg/kg | Experimental | Patients with a BMI > 50, who will be dosed according to ideal body weight. Receives: Drug: Sugammadex. 4 mg/kg; Procedure: Neuromuscular monitoring.; Procedure: Clinical evaluation of residual curarization . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete recovery of muscle relaxation, 30 minutes after end of surgery.
Measured with TOF Watch SX (TOF ratio > 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.
Measured: 30 minutes after end of surgery.
Time to complete recovery of muscle relaxation, 1 hour after the end of surgery.
Measured with TOF Watch SX (TOF ratio > 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.
Measured: 1hour after end of surgery.
Time to complete recovery of muscle relaxation, 1 hour 30 minutes after the end of surgery.
Measured with TOF Watch SX (TOF ratio > 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.
Measured: 1hour 30 minutes after end of surgery.
Time to complete recovery of muscle relaxation, 2 hours after the end of surgery.
Measured with TOF Watch SX (TOF ratio > 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.
Measured: 2 hours after end of surgery.
Secondary outcomes (1)
Need/use of rescue medication at the end of surgery
Additional administration of sugammadex 2 mg/kg Total Body Weight) at the end of surgery.
Measured: The hours following the end of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJan 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbidly Obese PatientsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jurgen Van Limmen, MD, Principal investigator, University Hospital, GhentLuc De Baerdemaeker, MD, PhD, Principal investigator, University Hospital, GhentKoen Reyntjens, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911520
- Sponsor's protocol ID
- 2010/207
- Other IDs
- 2009-016857-16, 2009
- Acronym
- BRIDION
- Status last verified
- Jul 2021
- First submitted
- 23 Jul 2013
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Finding Study for Effective Reversal of a Deep Rocuronium-induced Neuromuscular Block With Sugammadex in Morbidly Obese Patients.
- ClinicalTrials.gov ID
- NCT01911520
- Acronym / sponsor ID
- BRIDION / 2010/207
- Conditions
- Morbidly Obese Patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 30 Jul 2013 (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.
During laparoscopic bariatric surgery, adequate muscle relaxation is important to maintain good surgical conditions. To achieve this muscle relaxation, neuromuscular transmission blocking agents, such as rocuronium (Esmeron®) are used. It sometimes happens that there is still some neuromuscular blocking activity left in the patient on awakening from anesthesia. This is called residual curarization and is known to cause postoperative complications such as impairment of respiratory function.
Sugammadex (Bridion®) is a novel drug which selectively binds rocuronium (Esmeron®). It allows for reversing of neuromuscular transmission blocking activity. Until now, all studies with sugammadex were performed in non-obese patients.
Obese patient have a high risk to suffer from post-operative respiratory failure. Therefore it is vital to avoid residual curarization. Sugammadex might be an important factor.
Obese patients have a large total body weight different from ideal body weight. Recent research demonstrated that the dose for the neuromuscular blocking agent rocuronium (Esmeron®) needs to be calculated on the patients' Ideal Body Weight rather than on Total Body Weight.
At this moment no data is available on the dose-response relationship of sugammadex in morbidly obese patients.
We hypothesize that in morbidly obese patients sugammadex should be dosed on ideal bodyweight, instead of total bodyweight.
Detailed description
Flowchart :
72 participants
Stratification
BMI<50 BMI >50
Randomization Randomization
TBW IBW TBW IBW
2mg/kg n=9 2mg/kg n=9 2mg/kg n=9 2mg/kg n=9 4mg/kg n=9 4mg/kg n=9 4mg/kg n=9 4mg/kg n=9
TBW : Total Body Weight IBW : Ideal Body Weight
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| BMI < 50, Total Body Weight (TBW), 2mg/kg | Experimental | Drug: Sugammadex 2 mg/kg, Procedure: Neuromuscular monitoring., Procedure: Clinical evaluation of residual curarization .Patients with a BMI < 50, who will be dosed according to total body weight. |
| BMI < 50, TBW, 4 mg/kg | Experimental | Drug: Sugammadex. 4 mg/kg, Procedure: Neuromuscular monitoring., Procedure: Clinical evaluation of residual curarization .Patients with a BMI < 50, who will be dosed according to total body weight. |
| BMI < 50, Ideal Body Weight (IBW), 2 mg/kg | Experimental | Drug: Sugammadex 2 mg/kg, Procedure: Neuromuscular monitoring., Procedure: Clinical evaluation of residual curarization .Patients with a BMI < 50, who will be dosed according to ideal body weight. |
| BMI < 50, IBW, 4 mg/kg | Experimental | Drug: Sugammadex. 4 mg/kg, Procedure: Neuromuscular monitoring., Procedure: Clinical evaluation of residual curarization .Patients with a BMI < 50, who will be dosed according to ideal body weight. |
| BMI > 50, TBW, 2mg/kg | Experimental | Drug: Sugammadex 2 mg/kg, Procedure: Neuromuscular monitoring., Procedure: Clinical evaluation of residual curarization .Patients with a BMI > 50, who will be dosed according to total body weight. |
| BMI > 50, TBW, 4mg/kg | Experimental | Drug: Sugammadex. 4 mg/kg, Procedure: Neuromuscular monitoring., Procedure: Clinical evaluation of residual curarization .Patients with a BMI > 50, who will be dosed according to total body weight. |
| BMI >50, IBW, 2 mg/kg | Experimental | Drug: Sugammadex 2 mg/kg, Procedure: Neuromuscular monitoring., Procedure: Clinical evaluation of residual curarization .Patients with a BMI > 50, who will be dosed according to ideal body weight. |
| BMI >50, IBW, 4 mg/kg | Experimental | Drug: Sugammadex. 4 mg/kg, Procedure: Neuromuscular monitoring., Procedure: Clinical evaluation of residual curarization .Patients with a BMI > 50, who will be dosed according to ideal body weight. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I-II-III
- Age 18 - 65 year
- Male or female
- BMI > 30
Key exclusion criteria (8 listed)
- Renal failure
- Liver dysfunction
- Breastfeeding female patients, or female patients without reliable contraception
- Neuromuscular disease
- Malignant hyperthermia or a family history of malignant hyperthermia
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 2 mg/kgPatients receive 2 mg/kg Sugammadex. | Drug | BMI < 50, Ideal Body Weight (IBW), 2 mg/kg, BMI < 50, Total Body Weight (TBW), 2mg/kg, BMI > 50, TBW, 2mg/kg, BMI >50, IBW, 2 mg/kg |
| Sugammadex. 4 mg/kgPatients receive 4 mg/kg Sugammadex. | Drug | BMI < 50, IBW, 4 mg/kg, BMI < 50, TBW, 4 mg/kg, BMI > 50, TBW, 4mg/kg, BMI >50, IBW, 4 mg/kg |
| Neuromuscular monitoring.Neuromuscular monitoring using a TOF watch SX (Organon). | Procedure or surgery | BMI < 50, IBW, 4 mg/kg, BMI < 50, Ideal Body Weight (IBW), 2 mg/kg, BMI < 50, TBW, 4 mg/kg, BMI < 50, Total Body Weight (TBW), 2mg/kg, BMI > 50, TBW, 2mg/kg, BMI > 50, TBW, 4mg/kg, BMI >50, IBW, 2 mg/kg, BMI >50, IBW, 4 mg/kg |
| Clinical evaluation of residual curarization .Every 30 min, during the first 2 hours after the end of the surgery. | Procedure or surgery | BMI < 50, IBW, 4 mg/kg, BMI < 50, Ideal Body Weight (IBW), 2 mg/kg, BMI < 50, TBW, 4 mg/kg, BMI < 50, Total Body Weight (TBW), 2mg/kg, BMI > 50, TBW, 2mg/kg, BMI > 50, TBW, 4mg/kg, BMI >50, IBW, 2 mg/kg, BMI >50, IBW, 4 mg/kg |
Primary outcome
Time to complete recovery of muscle relaxation, 30 minutes after end of surgery.
Time frame: 30 minutes after end of surgery.
Measured with TOF Watch SX (TOF ratio > 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.
Time to complete recovery of muscle relaxation, 1 hour after the end of surgery.
Time frame: 1hour after end of surgery.
Measured with TOF Watch SX (TOF ratio > 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.
Time to complete recovery of muscle relaxation, 1 hour 30 minutes after the end of surgery.
Time frame: 1hour 30 minutes after end of surgery.
Measured with TOF Watch SX (TOF ratio > 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.
Time to complete recovery of muscle relaxation, 2 hours after the end of surgery.
Time frame: 2 hours after end of surgery.
Measured with TOF Watch SX (TOF ratio > 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.
1 secondary outcome
Need/use of rescue medication at the end of surgery
Time frame: The hours following the end of 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 13 Jul 2021.
- Related InfoLink provided by the sponsor.
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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.
Jurgen Van Limmen, MD principal investigator
University Hospital, Ghent
Luc De Baerdemaeker, MD, PhD principal investigator
University Hospital, Ghent
Koen Reyntjens, MD principal investigator
University Hospital, Ghent
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 2 mg/kg, Sugammadex. 4 mg/kg and Neuromuscular monitoring. in people with Morbidly Obese Patients, run by University Hospital, Ghent at 1 site in Belgium.
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 8 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 13 Jul 2021. 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 Belgium. 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?
Time to complete recovery of muscle relaxation, 30 minutes after end of surgery. (time frame: 30 minutes after end of surgery.). The study lists 4 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 13 Jul 2021.