Bariatric PatientsPhase 3NCT02713113
Efficacy of Low Dose Sugammadex in Reversal of NMB in Laparoscopic Barbaric Surgery
A Phase 3 study testing sugammadex reversal of neuromuscular blockade in people with Bariatric Patients, run by Assiut University at 1 site in Egypt.
Trial summary
the investigators aimed to compare the efficacy and safety of sugammadex at doses of 1.5, 2, and 4 mg/ kg for the reversal of moderate rocuronium-induced neuromuscular blockade in laparoscopic bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Patients
- What is being tested?
- sugammadex reversal of neuromuscular blockade
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2015to Mar 2016
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- morbidly obese patients of both sex (BMI > 40 kg.m-2)
- scheduled for elective laparoscopic bariatric surgery (gastric bypass or sleeve surgery) under general anesthesia using rocuronium for tracheal intubation and maintenance of NMB
- aged between 18 and 60 years and classified as ASA II - III
Who cannot join
- liver and renal dysfunction,
- disabling neuropsychiatric disorders,
- history of stroke, brain trauma in the last 12 months
- hypersensitivity to anesthetics, history of myocardial infarction, congestive heart failure
- difficult tracheal intubation, and known or suspected disorder affecting NMB.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Three Different Doses Sugammadex Based on Ideal Body Weight for Reversal of Moderate Rocuronium-induced Neuromuscular Blockade in Laparoscopic Bariatric Surgery.
the investigators aimed to compare the efficacy and safety of sugammadex at doses of 1.5, 2, and 4 mg/ kg for the reversal of moderate rocuronium-induced neuromuscular blockade in laparoscopic bariatric surgery.
Read the detailed description
Patients were randomly assigned using a randomization-computer program into three groups according to the dose of sugammadex administrated (according to the IBW after T2 of TOF):
Group I: patients were given 1.5 mg / kg. Group II: patients were given 2 mg / kg. Group III: patients were given 4 mg / kg.
- Conditions
- Bariatric Patients
- Being tested
- sugammadex reversal of neuromuscular blockade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugammadex reversal of neuromuscular blockadeDrug
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | patients were given 1.5 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF) Receives: Drug: sugammadex reversal of neuromuscular blockade |
| group II | Active comparator | patients were given 2 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF) Receives: Drug: sugammadex reversal of neuromuscular blockade |
| group III | Active comparator | patients were given 4 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF) Receives: Drug: sugammadex reversal of neuromuscular blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
sugammadex time following a dose of 1.5 mg / kg of sugammadex according to IBW in comparison to 2, and 4 mg / kg,
Measured: 2 hrs
Secondary outcomes (1)
extubation time
Measured: 2 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startMar 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric PatientsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Adel El sherif, Assiut University
- Investigators
- Ahmed H Othman, MD, Study director, ASSUIT UNVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713113
- Sponsor's protocol ID
- 250
- Status last verified
- Mar 2016
- First submitted
- 15 Mar 2016
- Last updated
- 21 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Different Doses Sugammadex Based on Ideal Body Weight for Reversal of Moderate Rocuronium-induced Neuromuscular Blockade in Laparoscopic Bariatric Surgery.
- ClinicalTrials.gov ID
- NCT02713113
- Acronym / sponsor ID
- 250
- Conditions
- Bariatric Patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 18 Mar 2016 (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.
the investigators aimed to compare the efficacy and safety of sugammadex at doses of 1.5, 2, and 4 mg/ kg for the reversal of moderate rocuronium-induced neuromuscular blockade in laparoscopic bariatric surgery.
Detailed description
Patients were randomly assigned using a randomization-computer program into three groups according to the dose of sugammadex administrated (according to the IBW after T2 of TOF):
Group I: patients were given 1.5 mg / kg. Group II: patients were given 2 mg / kg. Group III: patients were given 4 mg / kg.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Drug: sugammadex reversal of neuromuscular blockadepatients were given 1.5 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF) |
| group II | Active comparator | Drug: sugammadex reversal of neuromuscular blockadepatients were given 2 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF) |
| group III | Active comparator | Drug: sugammadex reversal of neuromuscular blockadepatients were given 4 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- morbidly obese patients of both sex (BMI > 40 kg.m-2)
- scheduled for elective laparoscopic bariatric surgery (gastric bypass or sleeve surgery) under general anesthesia using rocuronium for tracheal intubation and maintenance of NMB
- aged between 18 and 60 years and classified as ASA II - III
Key exclusion criteria (5 listed)
- liver and renal dysfunction,
- disabling neuropsychiatric disorders,
- history of stroke, brain trauma in the last 12 months
- hypersensitivity to anesthetics, history of myocardial infarction, congestive heart failure
- difficult tracheal intubation, and known or suspected disorder affecting NMB.
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 reversal of neuromuscular blockade | Drug | group 1, group II, group III |
Primary outcome
sugammadex time following a dose of 1.5 mg / kg of sugammadex according to IBW in comparison to 2, and 4 mg / kg,
Time frame: 2 hrs
1 secondary outcome
extubation time
Time frame: 2 hrs
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 21 Mar 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.
Ahmed H Othman, MD study director
ASSUIT UNVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sugammadex reversal of neuromuscular blockade in people with Bariatric Patients, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 5 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 21 Mar 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 Egypt. 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?
sugammadex time following a dose of 1.5 mg / kg of sugammadex according to IBW in comparison to 2, and 4 mg / kg, (time frame: 2 hrs). 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 21 Mar 2016.