AnesthesiaPhase 4NCT03725228
Lidocaine Compared to Magnesium Sulfate to Prolong Spinal Anesthesia: Non-inferiority Randomized Clinical Trial
A Phase 4 study testing Magnesium Sulfate and Lidocaine in people with Anesthesia and Pain, run by Brasilia University Hospital at 1 site in Brazil.
Trial summary
This study evaluates the addition of continuous infusion of lidocaine or continuous infusion of magnesium sufate in the duration of spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Anesthesia, Pain
- What is being tested?
- Magnesium Sulfate and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Nov 2018to 1 Apr 2019
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Will receive spinal anesthesia for TURP por Histerectomy
Who cannot join
- Protocol violation;
- Severe adverse events;
- Change to general anesthesia or addition of epidural anesthesia;
- Complete or partial spinal block failure;
- Mental status alteration (agitation, confusion, loss of conciousness).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Universitário de Brasilia
Brasília, Federal District, 70000000
About this study
This study evaluates the addition of continuous infusion of lidocaine or continuous infusion of magnesium sufate in the duration of spinal anesthesia.
Read the detailed description
Both lidocaine and magnesium sulfate have been shown to prolong spinal anesthesia.
The number of studies using magnesium sulfate to improve spinal anesthesia is greater than the number of studies using lidocaine, and methodology varies significantly between studies.
Adverse effects of lidocaine are different from magnesium sulfate's. Lidocaine has a wider therapeutic interval with fewer side effects, including: Drowsiness, Feeling Anxious, Feeling Cold, Nervous, Numbness And Tingling, Signs And Symptoms At Injection Site, Twitching.
Magnesium sulfate's side effects include: heart disturbances, breathing difficulties, poor reflexes, confusion, weakness, flushing (warmth, redness, or tingly feeling), sweating, lowered blood pressure, feeling like you might pass out, anxiety, cold feeling, extreme drowsiness, muscle tightness or contraction, or headache.
- Conditions
- Anesthesia, Pain
- Being tested
- Magnesium Sulfate, Lidocaine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Magnesium Sulfate 15mg/kg/h
LidocaineDrug
Lidocaine 1,5mg/kg/h
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Sulfate | Active comparator | Continuous intravenous infusion of 15mg/kg/h of magnesium sulfate, starting just after spinal anesthesia infusion until the end of surgery Receives: Drug: Magnesium Sulfate |
| Lidocaine | Experimental | Continuous intravenous infusion of 1.5mg/kg/h of lidocaine, starting just after spinal anesthesia infusion until the end of surgery Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitive block duration
Thermal and pinprick level lowering to S2
Measured: 9 hours
Secondary outcomes (3)
Motor block duration
Time to Bromage return to baseline
Measured: 9 hours
Two levels regression
Time from maximal thermal (cold) sensitive block level to lower two levels
Measured: 9 hours
Pain at postanesthesia care unit
Maximum pain (0-10 verbal scale) during PACU
Measured: 1-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start7 Nov 2018
- Primary completion1 Feb 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brasilia University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725228
- Sponsor's protocol ID
- tccRenato2018
- Status last verified
- Feb 2020
- First submitted
- 27 Oct 2018
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share de-identified IPD in Mendeley Data after study completion
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine Compared to Magnesium Sulfate to Prolong Spinal Anesthesia: Non-inferiority Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03725228
- Acronym / sponsor ID
- tccRenato2018
- Conditions
- Anesthesia, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Brasilia University HospitalUniversity, hospital or other
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 30 Oct 2018 (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.
This study evaluates the addition of continuous infusion of lidocaine or continuous infusion of magnesium sufate in the duration of spinal anesthesia.
Detailed description
Both lidocaine and magnesium sulfate have been shown to prolong spinal anesthesia.
The number of studies using magnesium sulfate to improve spinal anesthesia is greater than the number of studies using lidocaine, and methodology varies significantly between studies.
Adverse effects of lidocaine are different from magnesium sulfate's. Lidocaine has a wider therapeutic interval with fewer side effects, including: Drowsiness, Feeling Anxious, Feeling Cold, Nervous, Numbness And Tingling, Signs And Symptoms At Injection Site, Twitching.
Magnesium sulfate's side effects include: heart disturbances, breathing difficulties, poor reflexes, confusion, weakness, flushing (warmth, redness, or tingly feeling), sweating, lowered blood pressure, feeling like you might pass out, anxiety, cold feeling, extreme drowsiness, muscle tightness or contraction, or headache.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium Sulfate | Active comparator | Drug: Magnesium SulfateContinuous intravenous infusion of 15mg/kg/h of magnesium sulfate, starting just after spinal anesthesia infusion until the end of surgery |
| Lidocaine | Experimental | Drug: LidocaineContinuous intravenous infusion of 1.5mg/kg/h of lidocaine, starting just after spinal anesthesia infusion until the end of surgery |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Will receive spinal anesthesia for TURP por Histerectomy
Key exclusion criteria (5 listed)
- Protocol violation;
- Severe adverse events;
- Change to general anesthesia or addition of epidural anesthesia;
- Complete or partial spinal block failure;
- Mental status alteration (agitation, confusion, loss of conciousness).
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 |
|---|---|---|
| Magnesium SulfateMagnesium Sulfate 15mg/kg/h | Drug | Magnesium Sulfate |
| LidocaineLidocaine 1,5mg/kg/h | Drug | Lidocaine |
Primary outcome
Sensitive block duration
Time frame: 9 hours
Thermal and pinprick level lowering to S2
3 secondary outcomes
Motor block duration
Time frame: 9 hours
Two levels regression
Time frame: 9 hours
Pain at postanesthesia care unit
Time frame: 1-3 hours
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 27 Feb 2020.
- Individual participant dataSharing planned: Yes. We plan to share de-identified IPD in Mendeley Data after study completion
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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 4 study testing Magnesium Sulfate and Lidocaine in people with Anesthesia and Pain, run by Brasilia University Hospital 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 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 27 Feb 2020. 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. 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?
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?
Sensitive block duration (time frame: 9 hours). 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 27 Feb 2020.