Anesthesia and AnalgesiaMgSObsNCT05843812
Magnesium Sulfate in Bariatric Surgery
An observational study of Anesthesia and Analgesia and Magnesium Sulfate, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial summary
Weight loss surgery, also known as bariatric surgery, has been around since the 1950s and since its inception has been shown to successfully achieve significant and sustainable weight loss in a large number of patients who undergo this intervention, as well , if a beneficial impact is observed in the management of… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anesthesia and Analgesia, Magnesium Sulfate, Bariatric Surgery Candidate
- What is being tested?
- Magnesium Sulfate 10 MG/ML
- Type of treatment
- Injection or infusion
- How many people
- 104 participants
- Where
- 1 siteMexico
- Study dates
- 21 Apr 2023to 30 Jun 2024
- Phase
- Observational
- 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
Study population: Men and women over the age of 18, scheduled for bariatric surgery
Who may be able to join
- Patients scheduled for bariatric surgery under general o anesthesia at Hospital universitario de la Facultad de Medicina de la Universidad Autonoma de Coahuila
- Physical state ASA 2 y 3
- Acceptance and signing of the informed consent.
Who cannot join
- Treatment with calcium or magnesium channel blockers
- Drug use or alcoholism referred by the patient in the questioning
- Neurological diseases
- Myopathy
- Intracardiac block
- Renal insufficiency
Show all 14Show fewer
- Liver failure
- Pregnancy
- Hematological disorders
- Contraindications to the use of magnesium sulfate (hypersensitivity to the active principle or to any of the excipients, concomitant use with quinidine derivatives, tachycardia, heart failure, myocardial injury, infarction).
- Elimination criteria:
- Survey with incomplete data corresponding to the study variables.
- Revocation of informed consent or decision to withdraw by of the patient.
- Loss to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Evaluation of the Clinical Response to Magnesium Sulfate as an Adjuvant in Anesthesia in Bariatric Surgery"
Weight loss surgery, also known as bariatric surgery, has been around since the 1950s and since its inception has been shown to successfully achieve significant and sustainable weight loss in a large number of patients who undergo this intervention, as well , if a beneficial impact is observed in the management of metabolic disorders, such as type 2 diabetes mellitus and hyperlipidemia.
After bariatric surgery, patients are at risk of narcotic-related side effects.(2) Because of this, pain management strategies must be implemented to reduce the consumption of narcotic medications. Some studies have reported that a multimodal analgesic regimen can reduce the consumption of postoperative narcotics, as well as the therapy requirements to control postoperative nausea and vomiting.
Read more
It has also been reported that excess body mass is associated with changes in mineral levels in the body, particularly hypomagnesemia , a condition that is also common in hospitalized patients (Hansen \& Bruserud 2018), and has a high incidence in the perioperative environment.
Magnesium sulfate (MgSO4) has multiple desirable effects in an anesthetic procedure. It is an antagonist of the N-methyl-d-aspartic acid (NMDA) receptor, which is why it produces an analgesic effect related to the prevention of central sensitization caused by peripheral tissue injury. In addition, other relevant clinical effects of MgSO4 have been reported in anesthesiology, such as its effect as a CNS depressant, modulation of the hemodynamic response, reduction of the intraoperative requirements of anesthetics, analgesics, and muscle relaxants. As well as the potentiation of the effect of non-depolarizing muscle relaxants.
The role of magnesium in the body and its pharmacological properties continue to be studied and knowledge of its pharmacological, clinical and physiological characteristics has become essential for the anesthesiologist.
There are no previous studies that allow establishing an optimal therapeutic scheme considering all the perioperative clinical effects of MgSO4 and that evaluate the role of genetic variability in pain perception and response to treatment in bariatric surgery.
Read the detailed description
A total of 104 participants, men and women over the age of 18, scheduled for bariatric surgery, will be included. After accepting and signing the informed consent, a brief preoperative clinical history will be taken, a peripheral blood sample will be taken to determine preoperative serum Ca2+ and Mg2+, and to analyze polymorphic variants related to pain perception and the pharmacokinetics of analgesics. The clinical effect of MgSO4 on analgesia (EVAD), hemodynamic stability (BP and HR), intubation conditions, and satisfaction with anesthetic recovery will be evaluated. The presence of adverse reactions to anesthesia (nausea, vomiting, chills, pruritus, urinary retention, arrhythmias, laryngeal or bronchial spasm) and total doses of drugs used during the perioperative period will be recorded. All patients will undergo a standard pre, trans and postoperative protocol and according to the treatment received with MgSO4 as part of their anesthetic management or not, they will be assigned to the corresponding group (MgSO4/ No MgSO4). All the data will be collected in an Excel database, for subsequent analysis in SPSS.
- Being tested
- Magnesium Sulfate 10 MG/ML
- Keywords
- Analgesia, Anesthesia, Magnesium Sulfate, Bariatric Surgery, Pain Postoperative, Receptors, N-Methyl-D-Aspartate
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulfate 10 MG/MLDrug
Patients who received preoperative infusion with magnesium sulfate as part of their anesthetic management
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulphate | Patients who received preoperative infusion with magnesium sulfate as part of their anesthetic management Receives: Drug: Magnesium Sulfate 10 MG/ML | |
| No Magnesium sulphate | Patients who did not receive preoperative magnesium sulfate infusion as part of their anesthetic management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in postoperative analgesia over 24 hours
Postoperative pain intensity reported by the participant using the visual analog scale after bariatric surgery
Measured: [Time Frame: 15 minutes after coming out of anesthesia, 2, 4, 6 and 24 hours after coming out of anesthesia]
Time to first request for pain reliever
Time (minutes) to request analgesia after coming out of bariatric surgery
Measured: [Time Frame: 24 hours after departure from anesthesia]
Hemodynamic stability
Changes in heart rate (beats per minute) and mean systemic arterial pressure (mmHg) intraoperatively after or during bariatric surgery were combined to report hemodynamic stability.
Measurements of heart rate and mean arterial pressure will be added to arrive at a reported value (hemodynamic stability: yes or no).
Changes in heart rate (beats per minute) and mean systemic arterial pressure (mmHg) less than 20% with respect to baseline values will be considered as criteria for hemodynamic stability, without the need to administer atropine, ephedrine or other positive chronotropic agents and / or vasoactive agents.
Measured: [Time Frame: 180 minutes intraoperatively]
Interaction with neuromuscular blockers (BNM): Onset time
Parameters measured per train of four after administration of the non-depolarizing muscle relaxant according to the parameters established in the current guidelines for good clinical research practices in pharmacodynamic studies of neuromuscular blocking agents II:
- Onset time (OT): Time elapsed from the administration of BNM to obtaining a depression in the monitored motor response of between 80 to 100% with the T1 stimulus pattern of TOF.
Measured: [Time Frame: 180 minutes intraoperatively]
Interaction with neuromuscular blockers (BNM):Clinical effect time
Parameters measured per train of four after administration of the non-depolarizing muscle relaxant according to the parameters established in the current guidelines for good clinical research practices in pharmacodynamic studies of neuromuscular blocking agents II:
- Clinical effect time: Time elapsed from administration of BNM until 25% is recovered in the monitored motor response measured with TOF as T1> 25% or ST> 25%.
Measured: [Time Frame: 180 minutes intraoperatively]
Interaction with neuromuscular blockers (BNM): Recovery index (RI)
Parameters measured per train of four after administration of the non-depolarizing muscle relaxant according to the parameters established in the current guidelines for good clinical research practices in pharmacodynamic studies of neuromuscular blocking agents II:
- Recovery index (RI): Time elapsed between recovery of 25% and 75% of T1 from TOF.
Measured: [Time Frame: 180 minutes intraoperatively]
Secondary outcomes (9)
Adverse reactions to magnesium sulfate
Adverse reactions to the perioperative administration of parenteral magnesium sulfate that derive from magnesium poisoning or alterations in the administration site.
Administration site alterations (injection site pain, hypothermia, vasodilation with a sensation of heat).
Nervous system (loss of tendon reflex, headache, dizziness, coma, drowsiness and confusion, CNS depression, respiratory paralysis).
Cardiovascular system (circulatory collapse, arrhythmias, cardiac arrest).
Respiratory system (respiratory depression secondary to neuromuscular block).
Gastrointestinal system (nausea and vomiting).
Musculoskeletal and connective tissue system (muscle weakness).
Others (problems with speech, vision, excessive sweating, thirst, or others not reported).
Measured: [Time Frame: From the start of the magnesium sulfate infusion until 24 hours after leaving anesthesia]
Adverse reactions to anesthesia
Side and adverse effects associated with the use of anesthetic drugs.
Nausea, vomiting, itching, chills, urinary retention, arrhythmias, laryngeal or bronchial spasm.
Measured: [Time Frame: 180 minutes intraoperatively up to 24 hours after discharge from anesthesia]
Number of participants carrying polymorphisms related to perioperative clinical response to magnesium sulfate
Determination of polymorphisms related to the pharmacokinetics of opioids (gene CYP3A4/*16, CYP3A4/*1B), the NMDA receptor (GENE NR1/GRIN1, NR2/GRIN2A, NR2B/GRIN2B, NR3A/GRIN3A, NR3B/GRIN3B), and magnesium transporters (gene CNNM2, TRPM6, SLC41A1, SLC41A2).
Measured: [Time Frame: During the 2-year duration of the study]
Conditions for endotracheal intubation
Evaluation of the conditions for orotracheal intubation. Use a qualitative scoring system. The factors that are taken into consideration are: ease of laryngoscopy, position and / or movement of the vocal cords and reaction to intubation.
Measured: 5 minutes after the administration of BNM
Consumption of intraoperative analgesics
Consumption of analgesics (μg of fentanyl) intraoperatively in induction and / or maintenance in each group of patients.
Measured: 180 minutes intraoperatively
Postoperative analgesic consumption
Consumption of opioid analgesics (evaluated as mg morphine equivalents) postoperatively
Measured: From exit from anesthesia up to 24 hours
Consumption of neuromuscular relaxant
Consumption of neuromuscular relaxant (mg of cisatracurium) intraoperatively in intubation and / or maintenance after / during bariatric surgery, in each study group.
Measured: 180 minutes intraoperatively
Hypnotic use
Hypnotic consumption (mg of propofol) intraoperatively in intubation and / or maintenance after / during bariatric surgery, in each study group.
Measured: 180 minutes intraoperatively
Satisfaction in recovery from anesthesia
The overall satisfaction of the patients was evaluated the day after surgery using the IOWA scale (Dissatisfied: -3-2-1, Satisfied + 1 + 2 + 3) after bariatric surgery.
Measured: 24 hours after departure from anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start21 Apr 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia and AnalgesiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lilia Edith Luque Esparza, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843812
- Sponsor's protocol ID
- C.B/01-04-23
- Acronym
- MgSObs
- Status last verified
- May 2023
- First submitted
- 21 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluation of the Clinical Response to Magnesium Sulfate as an Adjuvant in Anesthesia in Bariatric Surgery"
- ClinicalTrials.gov ID
- NCT05843812
- Acronym / sponsor ID
- MgSObs / C.B/01-04-23
- Keywords
- Analgesia, Anesthesia, Magnesium Sulfate, Bariatric Surgery, Pain Postoperative, Receptors, N-Methyl-D-Aspartate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 6 May 2023 (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.
Weight loss surgery, also known as bariatric surgery, has been around since the 1950s and since its inception has been shown to successfully achieve significant and sustainable weight loss in a large number of patients who undergo this intervention, as well , if a beneficial impact is observed in the management of metabolic disorders, such as type 2 diabetes mellitus and hyperlipidemia.
After bariatric surgery, patients are at risk of narcotic-related side effects.(2) Because of this, pain management strategies must be implemented to reduce the consumption of narcotic medications. Some studies have reported that a multimodal analgesic regimen can reduce the consumption of postoperative narcotics, as well as the therapy requirements to control postoperative nausea and vomiting.
It has also been reported that excess body mass is associated with changes in mineral levels in the body, particularly hypomagnesemia , a condition that is also common in hospitalized patients (Hansen \& Bruserud 2018), and has a high incidence in the perioperative environment.
Magnesium sulfate (MgSO4) has multiple desirable effects in an anesthetic procedure. It is an antagonist of the N-methyl-d-aspartic acid (NMDA) receptor, which is why it produces an analgesic effect related to the prevention of central sensitization caused by peripheral tissue injury. In addition, other relevant clinical effects of MgSO4 have been reported in anesthesiology, such as its effect as a CNS depressant, modulation of the hemodynamic response, reduction of the intraoperative requirements of anesthetics, analgesics, and muscle relaxants. As well as the potentiation of the effect of non-depolarizing muscle relaxants.
The role of magnesium in the body and its pharmacological properties continue to be studied and knowledge of its pharmacological, clinical and physiological characteristics has become essential for the anesthesiologist.
There are no previous studies that allow establishing an optimal therapeutic scheme considering all the perioperative clinical effects of MgSO4 and that evaluate the role of genetic variability in pain perception and response to treatment in bariatric surgery.
Detailed description
A total of 104 participants, men and women over the age of 18, scheduled for bariatric surgery, will be included. After accepting and signing the informed consent, a brief preoperative clinical history will be taken, a peripheral blood sample will be taken to determine preoperative serum Ca2+ and Mg2+, and to analyze polymorphic variants related to pain perception and the pharmacokinetics of analgesics. The clinical effect of MgSO4 on analgesia (EVAD), hemodynamic stability (BP and HR), intubation conditions, and satisfaction with anesthetic recovery will be evaluated. The presence of adverse reactions to anesthesia (nausea, vomiting, chills, pruritus, urinary retention, arrhythmias, laryngeal or bronchial spasm) and total doses of drugs used during the perioperative period will be recorded. All patients will undergo a standard pre, trans and postoperative protocol and according to the treatment received with MgSO4 as part of their anesthetic management or not, they will be assigned to the corresponding group (MgSO4/ No MgSO4). All the data will be collected in an Excel database, for subsequent analysis in SPSS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulphate | – | Drug: Magnesium Sulfate 10 MG/MLPatients who received preoperative infusion with magnesium sulfate as part of their anesthetic management |
| No Magnesium sulphate | – | –Patients who did not receive preoperative magnesium sulfate infusion as part of their anesthetic management |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Men and women over the age of 18, scheduled for bariatric surgery
Key inclusion criteria (3 listed)
- Patients scheduled for bariatric surgery under general o anesthesia at Hospital universitario de la Facultad de Medicina de la Universidad Autonoma de Coahuila
- Physical state ASA 2 y 3
- Acceptance and signing of the informed consent.
Key exclusion criteria (14 listed)
- Treatment with calcium or magnesium channel blockers
- Drug use or alcoholism referred by the patient in the questioning
- Neurological diseases
- Myopathy
- Intracardiac block
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 Sulfate 10 MG/MLPatients who received preoperative infusion with magnesium sulfate as part of their anesthetic management | Drug | Magnesium sulphate |
Primary outcome
Changes in postoperative analgesia over 24 hours
Time frame: [Time Frame: 15 minutes after coming out of anesthesia, 2, 4, 6 and 24 hours after coming out of anesthesia]
Postoperative pain intensity reported by the participant using the visual analog scale after bariatric surgery
Time to first request for pain reliever
Time frame: [Time Frame: 24 hours after departure from anesthesia]
Time (minutes) to request analgesia after coming out of bariatric surgery
Hemodynamic stability
Time frame: [Time Frame: 180 minutes intraoperatively]
Changes in heart rate (beats per minute) and mean systemic arterial pressure (mmHg) intraoperatively after or during bariatric surgery were combined to report hemodynamic stability. Measurements of heart rate and mean arterial pressure will be added to arrive at a reported value (hemodynamic stability: yes or no). Changes in heart rate (beats per minute) and mean systemic arterial pressure (mmHg) less than 20% with respect to baseline values will be considered as criteria for hemodynamic stability, without the need to administer atropine, ephedrine or other positive chronotropic agents and / or vasoactive agents.
Interaction with neuromuscular blockers (BNM): Onset time
Time frame: [Time Frame: 180 minutes intraoperatively]
Parameters measured per train of four after administration of the non-depolarizing muscle relaxant according to the parameters established in the current guidelines for good clinical research practices in pharmacodynamic studies of neuromuscular blocking agents II: - Onset time (OT): Time elapsed from the administration of BNM to obtaining a depression in the monitored motor response of between 80 to 100% with the T1 stimulus pattern of TOF.
Interaction with neuromuscular blockers (BNM):Clinical effect time
Time frame: [Time Frame: 180 minutes intraoperatively]
Parameters measured per train of four after administration of the non-depolarizing muscle relaxant according to the parameters established in the current guidelines for good clinical research practices in pharmacodynamic studies of neuromuscular blocking agents II: - Clinical effect time: Time elapsed from administration of BNM until 25% is recovered in the monitored motor response measured with TOF as T1> 25% or ST> 25%.
Interaction with neuromuscular blockers (BNM): Recovery index (RI)
Time frame: [Time Frame: 180 minutes intraoperatively]
Parameters measured per train of four after administration of the non-depolarizing muscle relaxant according to the parameters established in the current guidelines for good clinical research practices in pharmacodynamic studies of neuromuscular blocking agents II: - Recovery index (RI): Time elapsed between recovery of 25% and 75% of T1 from TOF.
9 secondary outcomes
Adverse reactions to magnesium sulfate
Time frame: [Time Frame: From the start of the magnesium sulfate infusion until 24 hours after leaving anesthesia]
Adverse reactions to anesthesia
Time frame: [Time Frame: 180 minutes intraoperatively up to 24 hours after discharge from anesthesia]
Number of participants carrying polymorphisms related to perioperative clinical response to magnesium sulfate
Time frame: [Time Frame: During the 2-year duration of the study]
Conditions for endotracheal intubation
Time frame: 5 minutes after the administration of BNM
Consumption of intraoperative analgesics
Time frame: 180 minutes intraoperatively
Postoperative analgesic consumption
Time frame: From exit from anesthesia up to 24 hours
Consumption of neuromuscular relaxant
Time frame: 180 minutes intraoperatively
Hypnotic use
Time frame: 180 minutes intraoperatively
Satisfaction in recovery from anesthesia
Time frame: 24 hours after departure from anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Anesthesia and Analgesia and Magnesium Sulfate, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
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 14 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 6 May 2023. 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 Mexico. 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?
Results are not available in the source record.
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?
Changes in postoperative analgesia over 24 hours (time frame: [Time Frame: 15 minutes after coming out of anesthesia, 2, 4, 6 and 24 hours after coming out of anesthesia]). The study lists 6 primary outcomes in all. 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 6 May 2023; AzTrials last refreshed its copy on 31 Oct 2026.