Muscle RelaxationNCT03381209
The Effect of Sugammadex Given Based on Ideal, Actual or Adjusted Body Weight on Reversal of Rocuronium.
A study testing Sugammadex in people with Muscle Relaxation, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is compare the reversal of rocuronium induced neuromuscular blockade in morbidly obese patients using three doses of sugammadex; based on ideal body weight, adjusted body weight, and actual body weight. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Muscle Relaxation
- What is being tested?
- Sugammadex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2017to 10 Nov 2017
- Phase
- Interventional
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients older than 18 years and under 45 years,
- body mass index ≥ 40 kg/m2, with indication of bariatric surgery
Who cannot join
- Patients with comorbid including: neuromuscular disease, renal impairment, and patients with difficult airway were excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sugammadex Given Based on Ideal, Actual or Adjusted Body Weights on Reversal of Neuromuscular Blockade in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery
The aim of this study is compare the reversal of rocuronium induced neuromuscular blockade in morbidly obese patients using three doses of sugammadex; based on ideal body weight, adjusted body weight, and actual body weight.
Read the detailed description
The aim of this study is compare the reversal of rocuronium induced neuromuscular blockade in morbidly obese patients using three doses of sugammadex; based on ideal body weight, adjusted body weight, and actual body weight. Reversal Time: time from administration of Sugammadex to train of four (TOF) ratio ≥ 0.9 will be used as primary outcome.
Time need for extubation (time from administration of sugammadex to extubation), and duration of stay in post anesthesia care unit (PACU), will be used as secondary outcome.
- Conditions
- Muscle Relaxation
- Being tested
- Sugammadex
- Keywords
- Sugammadex, morbidly obese patients, bariatric surgery, neuromuscular blockade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Also called bridion
sugammadex given based on 3 measurements of body weights
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Sugammadex given in a dose of 2mg/kg based on ideal body weight Receives: Drug: Sugammadex |
| Group B | Experimental | Sugammadex given in a dose of 2mg/kg based on adjusted body weight Receives: Drug: Sugammadex |
| Group C | Experimental | Sugammadex given in a dose of 2mg/kg based on actual body weight Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversal Time
Reversal Time: time from administration of Sugammadex to train of four (TOF) ratio ≥ 0.9 will be used as primary outcome.
Measured: 5 minutes after sugammadex administration
Secondary outcomes (2)
duration of stay in PACU
period of stay in the PACU
Measured: 60 minutes after admission to the PACU
Time need for Extubation
time from administration of sugammadex to extubation
Measured: 10 minutes after sugammadex administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start10 Jun 2017
- Primary completion10 Nov 2017
- Study completion10 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle RelaxationStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Nofal, Ain Shams University
- Investigators
- Walid Nofal, MD, Principal investigator, Anesthesiology department, Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381209
- Sponsor's protocol ID
- FMASU R 39/2017
- Status last verified
- Dec 2017
- First submitted
- 17 Dec 2017
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sugammadex Given Based on Ideal, Actual or Adjusted Body Weights on Reversal of Neuromuscular Blockade in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03381209
- Acronym / sponsor ID
- FMASU R 39/2017
- Conditions
- Muscle Relaxation
- Keywords
- Sugammadex, morbidly obese patients, bariatric surgery, neuromuscular blockade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Jun 2017 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 21 Dec 2017 (actual)
- 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 aim of this study is compare the reversal of rocuronium induced neuromuscular blockade in morbidly obese patients using three doses of sugammadex; based on ideal body weight, adjusted body weight, and actual body weight.
Detailed description
The aim of this study is compare the reversal of rocuronium induced neuromuscular blockade in morbidly obese patients using three doses of sugammadex; based on ideal body weight, adjusted body weight, and actual body weight. Reversal Time: time from administration of Sugammadex to train of four (TOF) ratio ≥ 0.9 will be used as primary outcome.
Time need for extubation (time from administration of sugammadex to extubation), and duration of stay in post anesthesia care unit (PACU), will be used as secondary outcome.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: SugammadexSugammadex given in a dose of 2mg/kg based on ideal body weight |
| Group B | Experimental | Drug: SugammadexSugammadex given in a dose of 2mg/kg based on adjusted body weight |
| Group C | Experimental | Drug: SugammadexSugammadex given in a dose of 2mg/kg based on actual body weight |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients older than 18 years and under 45 years,
- body mass index ≥ 40 kg/m2, with indication of bariatric surgery
Key exclusion criteria (1 listed)
- Patients with comorbid including: neuromuscular disease, renal impairment, and patients with difficult airway were excluded from this study.
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 |
|---|---|---|
| SugammadexAlso: bridionsugammadex given based on 3 measurements of body weights | Drug | Group A, Group B, Group C |
Primary outcome
Reversal Time
Time frame: 5 minutes after sugammadex administration
Reversal Time: time from administration of Sugammadex to train of four (TOF) ratio ≥ 0.9 will be used as primary outcome.
2 secondary outcomes
duration of stay in PACU
Time frame: 60 minutes after admission to the PACU
Time need for Extubation
Time frame: 10 minutes after sugammadex administration
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 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Walid Nofal, MD principal investigator
Anesthesiology department, Faculty of Medicine, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugammadex in people with Muscle Relaxation, run by Ain Shams 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 2 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 21 Dec 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 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.
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?
Reversal Time (time frame: 5 minutes after sugammadex administration). 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 Dec 2017.