Magnesium SulfateNCT04005599
Opioid Sparing General Venous Anesthesia With Magnesium Sulfate
A study testing Remifentanil group and Magnesium sulfate group in people with Magnesium Sulfate and Postoperative Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Magnesium sulfate has been shown to be useful in many situations in medicine, such as eclampsia prevention and treatment, pulmonary hypertension, arterial pressure, asthma, cardiac arrhythmias and pheochromocytoma. Read more about this study
- Who is it for?
- Ages 18 to 18 years
- Conditions the study is for
- Magnesium Sulfate, Postoperative Pain, Opioid Use
- What is being tested?
- Remifentanil group and Magnesium sulfate group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Jun 2019to 6 Jan 2022
- 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 18 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 18 to 60 year-old
- body mass index < 35 kg/m²
- American Society of Anesthesiologists score < III
- agreement to participate and sign the informed consent form.
Who cannot join
- Allergy to any medications of the trial
- neuromuscular diagnosed disorder
- cardiac conduction blockade (atrioventricular block II or higher),
- use of illicit drugs
- use of calcium channel blockers
- creatinine > 2 mg/dl.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, 01246-903
About this study
Official title: Magnesium Sulfate in Substitution to Remifentanil. Intra-operative Analgesia Assessed by the Surgical Stress Index. Randomized and Blind Clinical Trial
Magnesium sulfate has been shown to be useful in many situations in medicine, such as eclampsia prevention and treatment, pulmonary hypertension, arterial pressure, asthma, cardiac arrhythmias and pheochromocytoma. Recently there has been a growing a big interest in this drug as an useful adjuvant in anesthesia, with analgesic and anesthetic sparing effect, antihyperalgesic property and potentialization of the neuromuscular blocker agent effect. On the other hand there has been a growing concern related to opioid administration, such as hyperalgesia, delayed return of intestinal function and the (still controversial) possibility of facilitating effect on tumor growth and metastases in cancer patients.
This project is based on a previous randomized, double blind prospective trial (conducted by one of these authors and not yet published) comparing two groups of patients who received general intravenous total anesthesia with propofol in controlled target infusion.
The surgical stress index is obtained by the interaction between the interval between heart beats and the amplitude of the photoplethysmography wave, whose algorithm generates a number related to the hemodynamic result of the increase of the sympathetic tone, which has shown to be the most sensitive resource in detecting the imbalance between the stimulus nociceptive and anti-nociception.
Read the detailed description
Magnesium sulfate has been shown to be useful in many situations in medicine, such as eclampsia prevention and treatment, pulmonary hypertension, arterial pressure, asthma, cardiac arrhythmias and pheochromocytoma. Recently there has been a growing a big interest in this drug as an useful adjuvant in anesthesia, with analgesic and anesthetic sparing effect, antihyperalgesic property and potentialization of the neuromuscular blocker agent effect. On the other hand there has been a growing concern related to opioid administration, such as hyperalgesia, delayed return of intestinal function and the (still controversial) possibility of facilitating effect on tumor growth and metastases in cancer patients.
This project is based on a previous randomized, double blind prospective trial (conducted by one of these authors and not yet published) comparing two groups of patients who received general intravenous total anesthesia with propofol in controlled target infusion.
The surgical stress index is obtained by the interaction between the interval between heart beats and the amplitude of the photoplethysmography wave, whose algorithm generates a number related to the hemodynamic result of the increase of the sympathetic tone, which has shown to be the most sensitive resource in detecting the imbalance between the stimulus nociceptive and anti-nociception.
Objectives The main objective of this project is to evaluate the feasibility of the use of magnesium sulfate in replacement of remifentanil as the main analgesic agent in total venous general anesthesia in patients submitted to post-bariatric dermolipectomy surgery.
The secondary objectives will be comparison of propofol consumption, time to onset of action, time of action and cisatracurium consumption between groups. We will evaluate pain scores in the immediate postoperative period and in the mornings and afternoons of the 3 days after surgery.
- Conditions
- Magnesium Sulfate, Postoperative Pain, Opioid Use
- Being tested
- Remifentanil group, Magnesium sulfate group
- Keywords
- Postoperative pain, opioid, Postoperative analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil groupDrug
Venous general anesthesia with propofol and remifentanil.
Magnesium sulfate groupDrug
Venous general anesthesia with propofol and magnesium sulfate
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil group | Active comparator | Intravenous anesthesia with propofol and remifentanil Receives: Drug: Remifentanil group |
| Magnesium group | Experimental | Intravenous anesthesia with propofol and magnesium sulfate Receives: Drug: Magnesium sulfate group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using magnesium sulfate as analgesic of venous general anesthesia
Changes in systolic blood pressure (mmHg) after tracheal intubation and surgical incision in both groups.
Measured: Surgery time
Secondary outcomes (3)
Anesthetic consumption.
Consumption of propofol (mg) and cisatracurium.
Measured: During surgery
Neuromuscular blocker action
Onset and offset of cisatracurium (minutes)
Measured: During surgery
Postoperative pain
Pain scores (verbal numerical scale from 0 to 10).
Measured: Three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start3 Jun 2019
- Primary completion6 Jan 2022
- Study completion6 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnesium SulfateStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, controlled, randomized and double-blind clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquim Edson Vieira, University of Sao Paulo General Hospital
- Investigators
- Joaquim Vieira, Professor, Principal investigator, University of Sao Paulo School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005599
- Sponsor's protocol ID
- CAAE 12614719.1.0000.0068
- Status last verified
- Nov 2022
- First submitted
- 25 Jun 2019
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have no plan to made individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Sulfate in Substitution to Remifentanil. Intra-operative Analgesia Assessed by the Surgical Stress Index. Randomized and Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04005599
- Acronym / sponsor ID
- CAAE 12614719.1.0000.0068
- Conditions
- Magnesium Sulfate, Postoperative Pain, Opioid Use
- Keywords
- Postoperative pain, opioid, Postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 6 Jan 2022 (actual)
- First posted
- 2 Jul 2019 (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.
Magnesium sulfate has been shown to be useful in many situations in medicine, such as eclampsia prevention and treatment, pulmonary hypertension, arterial pressure, asthma, cardiac arrhythmias and pheochromocytoma. Recently there has been a growing a big interest in this drug as an useful adjuvant in anesthesia, with analgesic and anesthetic sparing effect, antihyperalgesic property and potentialization of the neuromuscular blocker agent effect. On the other hand there has been a growing concern related to opioid administration, such as hyperalgesia, delayed return of intestinal function and the (still controversial) possibility of facilitating effect on tumor growth and metastases in cancer patients.
This project is based on a previous randomized, double blind prospective trial (conducted by one of these authors and not yet published) comparing two groups of patients who received general intravenous total anesthesia with propofol in controlled target infusion.
The surgical stress index is obtained by the interaction between the interval between heart beats and the amplitude of the photoplethysmography wave, whose algorithm generates a number related to the hemodynamic result of the increase of the sympathetic tone, which has shown to be the most sensitive resource in detecting the imbalance between the stimulus nociceptive and anti-nociception.
Detailed description
Magnesium sulfate has been shown to be useful in many situations in medicine, such as eclampsia prevention and treatment, pulmonary hypertension, arterial pressure, asthma, cardiac arrhythmias and pheochromocytoma. Recently there has been a growing a big interest in this drug as an useful adjuvant in anesthesia, with analgesic and anesthetic sparing effect, antihyperalgesic property and potentialization of the neuromuscular blocker agent effect. On the other hand there has been a growing concern related to opioid administration, such as hyperalgesia, delayed return of intestinal function and the (still controversial) possibility of facilitating effect on tumor growth and metastases in cancer patients.
This project is based on a previous randomized, double blind prospective trial (conducted by one of these authors and not yet published) comparing two groups of patients who received general intravenous total anesthesia with propofol in controlled target infusion.
The surgical stress index is obtained by the interaction between the interval between heart beats and the amplitude of the photoplethysmography wave, whose algorithm generates a number related to the hemodynamic result of the increase of the sympathetic tone, which has shown to be the most sensitive resource in detecting the imbalance between the stimulus nociceptive and anti-nociception.
Objectives The main objective of this project is to evaluate the feasibility of the use of magnesium sulfate in replacement of remifentanil as the main analgesic agent in total venous general anesthesia in patients submitted to post-bariatric dermolipectomy surgery.
The secondary objectives will be comparison of propofol consumption, time to onset of action, time of action and cisatracurium consumption between groups. We will evaluate pain scores in the immediate postoperative period and in the mornings and afternoons of the 3 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, controlled, randomized and double-blind clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Remifentanil group | Active comparator | Drug: Remifentanil groupIntravenous anesthesia with propofol and remifentanil |
| Magnesium group | Experimental | Drug: Magnesium sulfate groupIntravenous anesthesia with propofol and magnesium sulfate |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 18 to 60 year-old
- body mass index < 35 kg/m²
- American Society of Anesthesiologists score < III
- agreement to participate and sign the informed consent form.
Key exclusion criteria (6 listed)
- Allergy to any medications of the trial
- neuromuscular diagnosed disorder
- cardiac conduction blockade (atrioventricular block II or higher),
- use of illicit drugs
- use of calcium channel blockers
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 |
|---|---|---|
| Remifentanil groupVenous general anesthesia with propofol and remifentanil. | Drug | Remifentanil group |
| Magnesium sulfate groupVenous general anesthesia with propofol and magnesium sulfate | Drug | Magnesium group |
Primary outcome
Feasibility of using magnesium sulfate as analgesic of venous general anesthesia
Time frame: Surgery time
Changes in systolic blood pressure (mmHg) after tracheal intubation and surgical incision in both groups.
3 secondary outcomes
Anesthetic consumption.
Time frame: During surgery
Neuromuscular blocker action
Time frame: During surgery
Postoperative pain
Time frame: Three days
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 4 Nov 2022.
- Individual participant dataSharing planned: No. We have no plan to made individual participant data available to other researchers.
Related trials for Magnesium Sulfate
Recruiting
Intraperitoneal Dexmedetomidine Versus Magnesium as Adjuvants to Bupivacaine in Laparoscopic Cholecystectomy
Dexmedetomidine, Magnesium Sulfate
Not yet recruitingObservational study
Magnesium Sulfate for Prevention of Emergence Agitation in Lumbar Disc Surgery
Lumbar Disc Herniation, Emergence Agitation
RecruitingPhase 4
Effect of Magnesium Sulfate Bolus on Intraoperative Neuromonitoring
Intraoperative Neurophysiological Monitoring, Magnesium Sulfate
Not yet recruitingPhase 2
MAG-PAIN - MAGnesium for Postoperative Analgesia In the Newly Delivered
Postoperative Pain, Quality of Recovery (QoR-15)
RecruitingPhase 3
Antenatal Magnesium Sulphate in High-Risk Preterm Patients
Cerebral Palsy, Magnesium Sulfate Overdose
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.
Joaquim Vieira, Professor principal investigator
University of Sao Paulo School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil group and Magnesium sulfate group in people with Magnesium Sulfate and Postoperative Pain, run by University of Sao Paulo General 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 4 inclusion and 6 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 4 Nov 2022. 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.
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?
Feasibility of using magnesium sulfate as analgesic of venous general anesthesia (time frame: Surgery time). 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 4 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.