Magnesium SulfatePhase 4NCT02989272
Effect of Pre-treatment With Magnesium Sulfate on the Duration of Deep Neuromuscular Blockade With Rocuronium
A Phase 4 study testing Sulfate, Magnesium and saline group in people with Magnesium Sulfate and Neuromuscular Blockade, run by Hospital Federal de Bonsucesso at 1 site in Brazil.
Trial summary
It is a prospective, comparative, randomized, double-blind clinical trial whose hypothesis is that pre-treatment with magnesium sulfate, due to its action at the neuromuscular junction,potentiate the duration of deep neuromuscular block following rocuronium curarization in patients undergoing general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Magnesium Sulfate, Neuromuscular Blockade, Rocuronium
- What is being tested?
- Sulfate, Magnesium and saline group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2016to Dec 2017
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physical State American Society of Anesthesiologists (ASA) I, II and III; Body mass index between 18.5 and 24.9;Otorhinolaryngological surgeries
Who cannot join
- Refusal to participate in the study;
- Pregnancy or suspected pregnancy; Neuromuscular diseases, renal or hepatic impairment;
- Hepatic dysfunction;
- History or predictors of difficult airway; Hypermagnesemia (Mg> 2.5 mEq / L);
- Hypomagnesemia (Mg <1.7 mEq / L);
- Use of furosemide, aminoglycosides, aminophylline, azathioprine; Cyclophosphamide, anti-inflammatories and magnesium;
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- Allergy to the drugs used in the study;
- Participants from other clinical studies.
- Emergency surgeries.
Trial locations and contacts
1 site in 1 country.
Angelo Jorge Q R Micuci, doctor anesthesiology contact
Brazil1 site, 1 recruiting
- Recruiting
Bonsucesso Federal Hospital
Rio de Janeiro, Rio de Janeiro, 21.041-030
About this study
Official title: Effect of Pre-treatment With Magnesium Sulfate on the Duration of Deep Neuromuscular Blockade With Rocuronium: Random and Double-blind Clinical Study
It is a prospective, comparative, randomized, double-blind clinical trial whose hypothesis is that pre-treatment with magnesium sulfate, due to its action at the neuromuscular junction,potentiate the duration of deep neuromuscular block following rocuronium curarization in patients undergoing general anesthesia. Magnesium sulphate has gained prominence as an adjuvant drug in anesthesia. Its use is associated with potentiation of neuromuscular blockade among other functions.
The deep neuromuscular block is defined as the one obtained by the absence of response to the sequence of four Stimuli and the presence of one or more simple stimuli in post-tetanic counts . There is no literature description of the role of magnesium sulphate in Duration of the deep neuromuscular block obtained after the muscle relaxation of patients with rocuronium This study is justified because extending the clinical duration of neuromuscular blockers may translate into gains for surgeries that require deep and long-lasting muscle relaxation as in laparoscopic and robotic surgeries. This block allows lower inflation pressures of the pneumoperitoneum to be obtained, as a result, there is a lower inflammatory and cardiorespiratory repercussion for the patient
Read the detailed description
Patients will be selected from those who use the General Surgery Service of the Federal Hospital of Bonsucesso for medical indication or own will, obeying the inclusion and exclusion criteria. After signing the informed consent, they will be evaluated clinically and laboratorially, according to the routine of preoperative exams and pre-anesthetic outpatient evaluation. Patients will be allocated to one of two groups: control group (30 patients), who will receive pretreatment by venous infusion of saline solution; And magnesium group (30 patients) who will receive pretreatment by intravenous infusion of magnesium sulfate 60 mg / kg according to the random number sequence generated electronically through the QuickCalcs program (GraphPad Software, San Diego, CA) Because it is a double-blind study, both the researcher and the patient will not know which of the groups will be studied.
The principal investigator will be responsible for the delivery of sealed envelope containing the sequence of cases allocated in each of the groups to another anesthesiologist who will prepare the solution (saline or magnesium sulphate) and will record in a specific file in which group the volunteer was Allocated. Again the envelope will be sealed for tabulation later, without the knowledge of the researcher. The same principal investigator will be in charge of the measurement and recording of the data collected.
- Being tested
- Sulfate, Magnesium, saline group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfate, MagnesiumDrug
magnesium group (30 patients) who will receive pretreatment by intravenous infusion of magnesium sulfate 60 mg / kg
saline groupOther
saline group (30 patients) who will receive pretreatment by saline solution
| Study group | Role | What they receive |
|---|---|---|
| saline group | Placebo comparator | Control group (30 patients), who will receive Treatment by venous infusion of saline solution Receives: Other: saline group |
| Sulfate group | Experimental | magnesium group (30 patients) who will receive pre- Venous infusion of magnesium sulphate 60 mg / kg Receives: Drug: Sulfate, Magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of deep neuromuscular block
To determine the duration of deep neuromuscular block following a single dose of rocuronium
Measured: perioperative
Secondary outcomes (6)
onset time and recovery time of rocuronium
to determine the pharmacodynamic parameters of rocuronium
Measured: perioperative- until 48h
residual neuromuscular block in PACU
Evaluate the eventual occurrence of residual neuromuscular block in PACU
Measured: 6h
evolution of the height of T1
Record the evolution of the height of T1
Measured: perioperative- until 48h
postoperative pain
Evaluate postoperative pain with questionnaire and visual scale of pain
Measured: perioperative- until 48h
episodes of nausea and vomiting and treatment of surgery to discharge
Assess the frequency of individual episodes of nausea and vomiting and treatment during the period from the end of surgery to discharge
Measured: perioperative- until 48h
frequency of pain or unpleasant sensation
Evaluate frequency of pain or unpleasant sensation during the infusion of the studied solutions
Measured: perioperative- until 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Magnesium SulfateStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Federal de Bonsucesso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, angelo jorge queiroz rangel micuci, Hospital Federal de Bonsucesso
- Investigators
- Nubia V Figueiredo, master, Study director, Universidade Federal do Rio de JaneiroIsmar L Cavalcanti, master, Study director, Federal Fluminense UniversityAngelo Jorge Q R Micuci, doctor anesthesiology, Principal investigator, Hospital federal of Bonsucesso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989272
- Sponsor's protocol ID
- HFBonsucesso
- Status last verified
- Dec 2016
- First submitted
- 5 Dec 2016
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Queiroz Rangel Micuci AJ, Vercosa N, Filho PAG, de Boer HD, Barbosa DD, Cavalcanti IL. Effect of pretreatment with magnesium sulphate on the duration of intense and deep neuromuscular blockade with rocuronium: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jul;36(7):502-508. doi: 10.1097/EJA.0000000000001003.
PubMed 30985540
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-treatment With Magnesium Sulfate on the Duration of Deep Neuromuscular Blockade With Rocuronium: Random and Double-blind Clinical Study
- ClinicalTrials.gov ID
- NCT02989272
- Acronym / sponsor ID
- HFBonsucesso
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Federal de BonsucessoUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 12 Dec 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.
It is a prospective, comparative, randomized, double-blind clinical trial whose hypothesis is that pre-treatment with magnesium sulfate, due to its action at the neuromuscular junction,potentiate the duration of deep neuromuscular block following rocuronium curarization in patients undergoing general anesthesia. Magnesium sulphate has gained prominence as an adjuvant drug in anesthesia. Its use is associated with potentiation of neuromuscular blockade among other functions.
The deep neuromuscular block is defined as the one obtained by the absence of response to the sequence of four Stimuli and the presence of one or more simple stimuli in post-tetanic counts . There is no literature description of the role of magnesium sulphate in Duration of the deep neuromuscular block obtained after the muscle relaxation of patients with rocuronium This study is justified because extending the clinical duration of neuromuscular blockers may translate into gains for surgeries that require deep and long-lasting muscle relaxation as in laparoscopic and robotic surgeries. This block allows lower inflation pressures of the pneumoperitoneum to be obtained, as a result, there is a lower inflammatory and cardiorespiratory repercussion for the patient
Detailed description
Patients will be selected from those who use the General Surgery Service of the Federal Hospital of Bonsucesso for medical indication or own will, obeying the inclusion and exclusion criteria. After signing the informed consent, they will be evaluated clinically and laboratorially, according to the routine of preoperative exams and pre-anesthetic outpatient evaluation. Patients will be allocated to one of two groups: control group (30 patients), who will receive pretreatment by venous infusion of saline solution; And magnesium group (30 patients) who will receive pretreatment by intravenous infusion of magnesium sulfate 60 mg / kg according to the random number sequence generated electronically through the QuickCalcs program (GraphPad Software, San Diego, CA) Because it is a double-blind study, both the researcher and the patient will not know which of the groups will be studied.
The principal investigator will be responsible for the delivery of sealed envelope containing the sequence of cases allocated in each of the groups to another anesthesiologist who will prepare the solution (saline or magnesium sulphate) and will record in a specific file in which group the volunteer was Allocated. Again the envelope will be sealed for tabulation later, without the knowledge of the researcher. The same principal investigator will be in charge of the measurement and recording of the data collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| saline group | Placebo comparator | Other: saline groupControl group (30 patients), who will receive Treatment by venous infusion of saline solution |
| Sulfate group | Experimental | Drug: Sulfate, Magnesiummagnesium group (30 patients) who will receive pre- Venous infusion of magnesium sulphate 60 mg / kg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Physical State American Society of Anesthesiologists (ASA) I, II and III; Body mass index between 18.5 and 24.9;Otorhinolaryngological surgeries
Key exclusion criteria (9 listed)
- Refusal to participate in the study;
- Pregnancy or suspected pregnancy; Neuromuscular diseases, renal or hepatic impairment;
- Hepatic dysfunction;
- History or predictors of difficult airway; Hypermagnesemia (Mg> 2.5 mEq / L);
- Hypomagnesemia (Mg <1.7 mEq / L);
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 |
|---|---|---|
| Sulfate, Magnesiummagnesium group (30 patients) who will receive pretreatment by intravenous infusion of magnesium sulfate 60 mg / kg | Drug | Sulfate group |
| saline groupsaline group (30 patients) who will receive pretreatment by saline solution | Other | saline group |
Primary outcome
duration of deep neuromuscular block
Time frame: perioperative
To determine the duration of deep neuromuscular block following a single dose of rocuronium
6 secondary outcomes
onset time and recovery time of rocuronium
Time frame: perioperative- until 48h
residual neuromuscular block in PACU
Time frame: 6h
evolution of the height of T1
Time frame: perioperative- until 48h
postoperative pain
Time frame: perioperative- until 48h
episodes of nausea and vomiting and treatment of surgery to discharge
Time frame: perioperative- until 48h
frequency of pain or unpleasant sensation
Time frame: perioperative- until 48h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Derived from this study: PubMed 30985540Queiroz Rangel Micuci AJ, Vercosa N, Filho PAG, de Boer HD, Barbosa DD, Cavalcanti IL. Effect of pretreatment with magnesium sulphate on the duration of intense and deep neuromuscular blockade with rocuronium: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jul;36(7):502-508. doi: 10.1097/EJA.0000000000001003.
- Individual participant dataSharing planned: Yes
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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.
Angelo Jorge Q R Micuci, doctor anesthesiology contact
Nubia V Figueiredo, master study director
Universidade Federal do Rio de Janeiro
Ismar L Cavalcanti, master study director
Federal Fluminense University
Angelo Jorge Q R Micuci, doctor anesthesiology principal investigator
Hospital federal of Bonsucesso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sulfate, Magnesium and saline group in people with Magnesium Sulfate and Neuromuscular Blockade, run by Hospital Federal de Bonsucesso at 1 site in Brazil.
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 9 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: status not confirmed, as of the sponsor's last update on 12 Dec 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 Brazil. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angelo Jorge Q R Micuci, doctor anesthesiology (21997828668 ext. 55, angelojorgemicuci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of deep neuromuscular block (time frame: perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02989272, which also lists 1 linked publication.
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 Dec 2016.