Evaluation of the Clinical Response to Magnesium Sulfate as an Adjunct in the Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Changes in postoperative analgesia over 24 hours
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Triple blind: Participants and researchers will be unaware of the type of intervention used (administration of MgSO4 or Placebo).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for elective surgery under general or regional anesthesia at Hospital General de Zona No.
- •Physical state ASA 1 and 2
- •BMI 18-30 kg / m2
- •Acceptance and signing of the informed consent.
排除标准
- •Treatment with calcium or magnesium channel blockers
- •Drug use or alcoholism referred by the patient in the questioning
- •Neurological diseases
- •Intracardiac block
- •Renal insufficiency
- •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
研究组 & 干预措施
Magnesium sulphate
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
干预措施: Perioperative magnesium sulfate (Drug)
Placebo
Administration of intravenous physiological solution (NaCl 0.9%) as a complement to anesthesia.
Dose: equivalent to that administered in the MgSO4 group
干预措施: Perioperative magnesium sulfate (Drug)
结局指标
主要结局
Changes in postoperative analgesia over 24 hours
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
Adverse reactions to anesthesia
时间窗: 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
时间窗: 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).
Interaction with neuromuscular blockers (BNM):Clinical effect time
时间窗: 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)
时间窗: 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
时间窗: 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).
次要结局
- Conditions for endotracheal intubation(5 minutes after the administration of BNM)
- Consumption of intraoperative analgesics(180 minutes intraoperatively)
- Postoperative analgesic consumption(From exit from anesthesia up to 24 hours)
- Consumption of neuromuscular relaxant(180 minutes intraoperatively)
- Hypnotic use(180 minutes intraoperatively)
- Satisfaction in recovery from anesthesia(24 hours after departure from anesthesia)
研究者
Lilia Edith Luque Esparza
Principal Investigator
Instituto Mexicano del Seguro Social