Ignite Creation Date:
2024-05-06 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05227716
Status:
RECRUITING
Last Update Posted:
2023-03-17
First Post:
2021-12-30
Brief Title:
Clinical Response to Magnesium Sulfate as an Adjunct in the Anesthesia
Sponsor:
Instituto Mexicano del Seguro Social
Organization:
Instituto Mexicano del Seguro Social
Study Overview
Official Title:
Evaluation of the Clinical Response to Magnesium Sulfate as an Adjunct in the Anesthesia
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 09 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 09 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 02 mg kg IV will be applied Anesthesia will be maintained with 100 oxygen and 05 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 09 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
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 09 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 02 mg kg IV will be applied Anesthesia will be maintained with 100 oxygen and 05 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 09 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None