Anesthesia and AnalgesiaPhase 4NCT05227716
Clinical Response to Magnesium Sulfate as an Adjunct in the Anesthesia
A Phase 4 study testing Perioperative magnesium sulfate in people with Anesthesia and Analgesia and Magnesium Sulfate, run by Instituto Mexicano del Seguro Social at 2 sites in Mexico.
Trial summary
Magnesium sulfate (MgSO4) has multiple desirable effects in an anesthetic procedure, including modulation of the hemodynamic response to surgical stress, perioperative anesthetic and analgesic effect, potentiation of neuromuscular blockade, and central nervous system depression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia and Analgesia, Magnesium Sulfate
- What is being tested?
- Perioperative magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 2 sitesMexico
- Study dates
- 1 Oct 2022to 31 Jul 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective surgery under general or regional anesthesia at Hospital General de Zona No. 51.
- Physical state ASA 1 and 2
- BMI 18-30 kg / m2
- 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
2 sites in 1 country.
Mexico2 sites, 2 recruiting
- Recruiting
Instituto Mexicano Del Seguro Social
Gómez Palacio, Durango, 35025
LILIA EDITH Edith LUQUE ESPARZA, DRA, +528715796441, dra.luque@gmail.com
- Not yet recruiting
Lilia Edith Luque-Esparza
Gómez Palacio, Durango, 35025
Lilia E Luque-Esparza, Dra., 8715796441, dra.luque@gmail.com
Dealmy Delgadillo-Guzmán, Dra., +8711324472, dealmyelgadilloguz@uadec.edu.mx
About this study
Official title: Evaluation of the Clinical Response to Magnesium Sulfate as an Adjunct in the Anesthesia
Magnesium sulfate (MgSO4) has multiple desirable effects in an anesthetic procedure, including modulation of the hemodynamic response to surgical stress, perioperative anesthetic and analgesic effect, potentiation of neuromuscular blockade, and central nervous system depression. MgSO4 is an antagonist of the N-methyl-d-aspartic acid (NMDA) receptor, therefore it produces an analgesic effect related to the prevention of central sensitization caused by peripheral tissue damage.
Objective. To evaluate the perioperative clinical response to MgSO4 as an adjunct to anesthesia.
Material and method. Randomized, triple-blind clinical trial that will include men and women over 18 years of age, scheduled for surgery under general or regional anesthesia. After accepting and signing the informed consent, all patients will be subjected to the same pre, trans and postoperative protocol and will be assigned to 2 groups according to the intravenous administration of MgSO4 (placebo and MgSO4). A brief preoperative medical history will be taken, a peripheral blood sample will be taken to determine preoperative serum Mg, the clinical effect of MgSO4 on trans and postoperative analgesia (EVAD), hemodynamic stability (blood pressure (BP) and heart rate ( HR)), motor and neuromuscular block time (Bromage and TOF), and recovery time. The presence of adverse reactions to anesthesia (nausea, vomiting, chills, pruritus, urinary retention, arrhythmias, laryngeal or bronchial spasm) and those secondary to the administration of Mg, SO4, as well as the total doses of all drugs used during the perioperative. The data will be analyzed in the SPSS software.
Read the detailed description
The participant selection process will be carried out through direct invitation to patients scheduled for surgery under regional or general anesthesia at the General Hospital of Zone No. 51 of the IMSS, Gómez Palacio, Durango. Explaining what their participation consists of for the subsequent signing of the informed consent letter in case of accepting. Afterwards, according to the type of surgery and scheduled anesthesia, 2 groups will be integrated randomly and blindly for the investigator: one that will receive MgSO4 pre and intraoperatively and another group that will be administered 0.9% NaCl intravenously (placebo). All participants will undergo the same pre, trans and postoperative surgical and anesthetic protocol.
Personal data, background and sociodemographic variables will be collected in a data collection sheet. Subsequently, anthropometric measurements will be made to determine weight, height, body mass index and blood pressure.
Peripheral venous blood samples will be taken in the operating room for the determination of pre and postoperative serum Mg and other analyzes.
Each participant will receive standard and continuous monitoring (electrocardiogram, oxygen saturation, blood pressure, capnography, temperature and TOF) and an intravenous access will be established. The MgSO4 group will receive 30 mg / kg of magnesium sulfate intravenously over a period of 15 minutes before induction of anesthesia and 10 mg / kg / h by continuous intravenous infusion during the operation. The control group (placebo) will receive 0.9% NaCl in the same volume as the study drug.
In procedures under general anesthesia, a standard protocol with propofol 2 mg / kg (IV), fentanyl 2 μg / kg (IV) and cisatracurium 0.2 mg / kg (IV) will be applied. Anesthesia will be maintained with 100% oxygen, and 0.5 to 4 vol% sevoflurane, to achieve a mean alveolar concentration (MAC) of 50%. Maintenance doses of fentanyl will be added to the anesthesia regimen as needed. The maintenance dose of cisatracurium will be administered according to the MNM with TOF. The total doses of the drugs used will be recorded. In cases with neuraxial regional anesthesia, a standard protocol with 10 mg heavy bupivacaine and subarachnoid buprenorphine 60 mcg will be applied.
Hemodynamic parameters will be recorded at baseline (before administration of magnesium sulfate or 0.9% isotonic saline solution and subsequently every 5 minutes during surgery, up to 180 minutes after drug administration.
Low blood pressure during surgery, defined as a mean blood pressure value <50 mmHg, will be treated with a 5 mg bolus of ephedrine given intravenously or norepinephrine by IV infusion for persistent hypotension (this is the standard anesthetic management of variations in hemodynamic stability). Low heart rate during surgery, defined as <50 beats per minute, will be treated with atropine at 10 mcg / kg intravenously.
The time until the MNM with TOF indicates the suitability of the neuromuscular block for intubation will be recorded, and the intubation conditions will be evaluated.
The postoperative analgesic protocol will include ketorolac 30mg IV, tramadol 100mg IV, or lysine clonixinate 100mg in case of allergy to ketorolac. Buprenorphine will be administered subcutaneously at a dose of 2 mcg / kg as rescue analgesia only when necessary.
As an adjunct to anesthesia, dexamethasone 8 mg IV, metoclopramide 10 mg IV, ondansetron 100 mcg / kg and omeprazole 40 mg IV will be administered.
Post-operative pain assessment will be performed by EVAD upon exiting anesthesia and at 2, 4, 6, and 24 hours.
The time elapsed until the first request for additional analgesic by the patient, and the total consumption of postoperative analgesics will be recorded, recording it as morphine equivalents.
All the information about all the drugs administered to the patient during their perioperative stay will be collected.
Episodes of nausea, vomiting, itching, chills, arrhythmias, laryngeal or bronchial spasm will be recorded during and after coming out of anesthesia and at the end of the hospital stay.
Satisfaction in recovery from anesthesia will be assessed at 24 hours by delivering a self-report questionnaire to patients.
Finally, the data will be captured in a database for subsequent statistical analysis.
- Conditions
- Anesthesia and Analgesia, Magnesium Sulfate
- Being tested
- Perioperative magnesium sulfate
- Keywords
- Magnesium Sulfate, Anesthesia, Analgesia, 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.
Perioperative magnesium sulfateDrug
Administration of magnesium sulfate as an adjunct in anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulphate | Experimental | Administration of intravenous MgSO4 as an adjunct to anesthesia.
Dose: 30 mg / kg of MgSO4 IV 15 minutes before induction of anesthesia and 10 mg / kg / h in continuous IV infusion during the operation Receives: Drug: Perioperative magnesium sulfate |
| Placebo | Placebo comparator | Administration of intravenous physiological solution (NaCl 0.9%) as a complement to anesthesia.
Dose: equivalent to that administered in the MgSO4 group Receives: Drug: Perioperative magnesium sulfate |
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 intravenous infusion of magnesium sulfate or placebo (NaCl at 0.9%).
Measured: 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 anesthesia after intravenous infusion of magnesium sulfate or placebo (NaCl at 0.9%).
Measured: 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 intravenous infusion of magnesium sulfate or normal saline (0.9% NaCl) were combined to report hemodynamic stability.
Changes in heart rate (beats per minute) and mean systemic arterial pressure (mmHg) of less than 20% without the need to administer atropine, ephedrine or other positive chronotropic agents and/or vasoactive agents are considered criteria of hemodynamic stability.
Measured: 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: 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: 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: 180 minutes intraoperatively
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: 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: 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: During the 3-year duration of the study
Secondary outcomes (6)
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 after / during intravenous infusion of magnesium sulfate or placebo (NaCl at 0.9%), in each group of patients.
Measured: 180 minutes intraoperatively
Postoperative analgesic consumption
Consumption of opioid analgesics (evaluated as mg morphine equivalents) postoperatively after intravenous infusion of magnesium sulfate or placebo (NaCl at 0.9%).
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 intravenous infusion of magnesium sulfate or placebo (0.9% NaCl), in each study group.
Measured: 180 minutes intraoperatively
Hypnotic use
Hypnotic consumption (mg of propofol) intraoperatively in intubation and / or maintenance after / during intravenous infusion of magnesium sulfate or placebo (NaCl at 0.9%), 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 intravenous infusion of magnesium sulfate or placebo (NaCl at 0.9%).
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 posted7 Feb 2022
- Study start1 Oct 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jul 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Clinical trial: An intervention will be carried out in the population to be studied for the purpose of the research and there will be a control group. * Triple blind: Participants and researchers will be unaware of the type of intervention used (administration of MgSO4 or Placebo). * Randomized: A list of random numbers will be used to assign patients to study groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- NCT05227716
- Sponsor's protocol ID
- R-2021-902-040
- Status last verified
- Mar 2023
- First submitted
- 30 Dec 2021
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This item has not yet been defined
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 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 Adjunct in the Anesthesia
- ClinicalTrials.gov ID
- NCT05227716
- Acronym / sponsor ID
- R-2021-902-040
- Conditions
- Anesthesia and Analgesia, Magnesium Sulfate
- Keywords
- Magnesium Sulfate, Anesthesia, Analgesia, Pain, Postoperative, Receptors, N-Methyl-D-Aspartate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 7 Feb 2022 (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 (MgSO4) has multiple desirable effects in an anesthetic procedure, including modulation of the hemodynamic response to surgical stress, perioperative anesthetic and analgesic effect, potentiation of neuromuscular blockade, and central nervous system depression. MgSO4 is an antagonist of the N-methyl-d-aspartic acid (NMDA) receptor, therefore it produces an analgesic effect related to the prevention of central sensitization caused by peripheral tissue damage.
Objective. To evaluate the perioperative clinical response to MgSO4 as an adjunct to anesthesia.
Material and method. Randomized, triple-blind clinical trial that will include men and women over 18 years of age, scheduled for surgery under general or regional anesthesia. After accepting and signing the informed consent, all patients will be subjected to the same pre, trans and postoperative protocol and will be assigned to 2 groups according to the intravenous administration of MgSO4 (placebo and MgSO4). A brief preoperative medical history will be taken, a peripheral blood sample will be taken to determine preoperative serum Mg, the clinical effect of MgSO4 on trans and postoperative analgesia (EVAD), hemodynamic stability (blood pressure (BP) and heart rate ( HR)), motor and neuromuscular block time (Bromage and TOF), and recovery time. The presence of adverse reactions to anesthesia (nausea, vomiting, chills, pruritus, urinary retention, arrhythmias, laryngeal or bronchial spasm) and those secondary to the administration of Mg, SO4, as well as the total doses of all drugs used during the perioperative. The data will be analyzed in the SPSS software.
Detailed description
The participant selection process will be carried out through direct invitation to patients scheduled for surgery under regional or general anesthesia at the General Hospital of Zone No. 51 of the IMSS, Gómez Palacio, Durango. Explaining what their participation consists of for the subsequent signing of the informed consent letter in case of accepting. Afterwards, according to the type of surgery and scheduled anesthesia, 2 groups will be integrated randomly and blindly for the investigator: one that will receive MgSO4 pre and intraoperatively and another group that will be administered 0.9% NaCl intravenously (placebo). All participants will undergo the same pre, trans and postoperative surgical and anesthetic protocol.
Personal data, background and sociodemographic variables will be collected in a data collection sheet. Subsequently, anthropometric measurements will be made to determine weight, height, body mass index and blood pressure.
Peripheral venous blood samples will be taken in the operating room for the determination of pre and postoperative serum Mg and other analyzes.
Each participant will receive standard and continuous monitoring (electrocardiogram, oxygen saturation, blood pressure, capnography, temperature and TOF) and an intravenous access will be established. The MgSO4 group will receive 30 mg / kg of magnesium sulfate intravenously over a period of 15 minutes before induction of anesthesia and 10 mg / kg / h by continuous intravenous infusion during the operation. The control group (placebo) will receive 0.9% NaCl in the same volume as the study drug.
In procedures under general anesthesia, a standard protocol with propofol 2 mg / kg (IV), fentanyl 2 μg / kg (IV) and cisatracurium 0.2 mg / kg (IV) will be applied. Anesthesia will be maintained with 100% oxygen, and 0.5 to 4 vol% sevoflurane, to achieve a mean alveolar concentration (MAC) of 50%. Maintenance doses of fentanyl will be added to the anesthesia regimen as needed. The maintenance dose of cisatracurium will be administered according to the MNM with TOF. The total doses of the drugs used will be recorded. In cases with neuraxial regional anesthesia, a standard protocol with 10 mg heavy bupivacaine and subarachnoid buprenorphine 60 mcg will be applied.
Hemodynamic parameters will be recorded at baseline (before administration of magnesium sulfate or 0.9% isotonic saline solution and subsequently every 5 minutes during surgery, up to 180 minutes after drug administration.
Low blood pressure during surgery, defined as a mean blood pressure value <50 mmHg, will be treated with a 5 mg bolus of ephedrine given intravenously or norepinephrine by IV infusion for persistent hypotension (this is the standard anesthetic management of variations in hemodynamic stability). Low heart rate during surgery, defined as <50 beats per minute, will be treated with atropine at 10 mcg / kg intravenously.
The time until the MNM with TOF indicates the suitability of the neuromuscular block for intubation will be recorded, and the intubation conditions will be evaluated.
The postoperative analgesic protocol will include ketorolac 30mg IV, tramadol 100mg IV, or lysine clonixinate 100mg in case of allergy to ketorolac. Buprenorphine will be administered subcutaneously at a dose of 2 mcg / kg as rescue analgesia only when necessary.
As an adjunct to anesthesia, dexamethasone 8 mg IV, metoclopramide 10 mg IV, ondansetron 100 mcg / kg and omeprazole 40 mg IV will be administered.
Post-operative pain assessment will be performed by EVAD upon exiting anesthesia and at 2, 4, 6, and 24 hours.
The time elapsed until the first request for additional analgesic by the patient, and the total consumption of postoperative analgesics will be recorded, recording it as morphine equivalents.
All the information about all the drugs administered to the patient during their perioperative stay will be collected.
Episodes of nausea, vomiting, itching, chills, arrhythmias, laryngeal or bronchial spasm will be recorded during and after coming out of anesthesia and at the end of the hospital stay.
Satisfaction in recovery from anesthesia will be assessed at 24 hours by delivering a self-report questionnaire to patients.
Finally, the data will be captured in a database for subsequent statistical analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- * Clinical trial: An intervention will be carried out in the population to be studied for the purpose of the research and there will be a control group. * Triple blind: Participants and researchers will be unaware of the type of intervention used (administration of MgSO4 or Placebo). * Randomized: A list of random numbers will be used to assign patients to study groups.
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulphate | Experimental | Drug: Perioperative magnesium sulfateAdministration of intravenous MgSO4 as an adjunct to anesthesia. Dose: 30 mg / kg of MgSO4 IV 15 minutes before induction of anesthesia and 10 mg / kg / h in continuous IV infusion during the operation |
| Placebo | Placebo comparator | Drug: Perioperative magnesium sulfateAdministration of intravenous physiological solution (NaCl 0.9%) as a complement to anesthesia. Dose: equivalent to that administered in the MgSO4 group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for elective surgery under general or regional anesthesia at Hospital General de Zona No. 51.
- Physical state ASA 1 and 2
- BMI 18-30 kg / m2
- 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 |
|---|---|---|
| Perioperative magnesium sulfateAdministration of magnesium sulfate as an adjunct in anesthesia | Drug | Magnesium sulphate, Placebo |
Primary outcome
Changes in postoperative analgesia over 24 hours
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 intravenous infusion of magnesium sulfate or placebo (NaCl at 0.9%).
Time to first request for pain reliever
Time frame: 24 hours after departure from anesthesia
Time (minutes) to request analgesia after coming out of anesthesia after intravenous infusion of magnesium sulfate or placebo (NaCl at 0.9%).
Hemodynamic stability
Time frame: 180 minutes intraoperatively
Changes in heart rate (beats per minute) and mean systemic arterial pressure (mmHg) intraoperatively after or during intravenous infusion of magnesium sulfate or normal saline (0.9% NaCl) were combined to report hemodynamic stability. Changes in heart rate (beats per minute) and mean systemic arterial pressure (mmHg) of less than 20% without the need to administer atropine, ephedrine or other positive chronotropic agents and/or vasoactive agents are considered criteria of hemodynamic stability.
Interaction with neuromuscular blockers (BNM): Onset time
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: 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: 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.
Adverse reactions to magnesium sulfate
Time frame: From the start of the magnesium sulfate infusion until 24 hours after leaving anesthesia
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).
Adverse reactions to anesthesia
Time frame: 180 minutes intraoperatively up to 24 hours after discharge from anesthesia
Side and adverse effects associated with the use of anesthetic drugs. Nausea, vomiting, itching, chills, urinary retention, arrhythmias, laryngeal or bronchial spasm.
Number of participants carrying polymorphisms related to perioperative clinical response to magnesium sulfate
Time frame: During the 3-year duration of the study
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).
6 secondary outcomes
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 17 Mar 2023.
- Individual participant dataSharing planned: Undecided. This item has not yet been defined
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Perioperative magnesium sulfate in people with Anesthesia and Analgesia and Magnesium Sulfate, run by Instituto Mexicano del Seguro Social at 2 sites 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 4 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 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 Lilia E Luque-Esparza, Dra. (+528715796441, dra.luque@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in postoperative analgesia over 24 hours (time frame: 15 minutes after coming out of anesthesia, 2, 4, 6 and 24 hours after coming out of anesthesia). The study lists 9 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 17 Mar 2023.