"Evaluation of the Clinical Response to Magnesium Sulfate as an Adjuvant in Anesthesia in Bariatric Surgery"
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Changes in postoperative analgesia over 24 hours
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
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
Patients who received preoperative infusion with magnesium sulfate as part of their anesthetic management
干预措施: Magnesium Sulfate 10 MG/ML (Drug)
结局指标
主要结局
Changes in postoperative analgesia over 24 hours
时间窗: [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
Interaction with neuromuscular blockers (BNM): Recovery index (RI)
时间窗: [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.
Interaction with neuromuscular blockers (BNM): Onset time
时间窗: [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.
Time to first request for pain reliever
时间窗: [Time Frame: 24 hours after departure from anesthesia]
Time (minutes) to request analgesia after coming out of bariatric surgery
Hemodynamic stability
时间窗: [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):Clinical effect time
时间窗: [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%.
次要结局
- Number of participants carrying polymorphisms related to perioperative clinical response to magnesium sulfate([Time Frame: During the 2-year duration of the study])
- Adverse reactions to anesthesia([Time Frame: 180 minutes intraoperatively up to 24 hours after discharge from anesthesia])
- Satisfaction in recovery from anesthesia(24 hours after departure from anesthesia)
- Adverse reactions to magnesium sulfate([Time Frame: From the start of the magnesium sulfate infusion until 24 hours after leaving anesthesia])
- 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)
- Conditions for endotracheal intubation(5 minutes after the administration of BNM)
- Hypnotic use(180 minutes intraoperatively)
研究者
Lilia Edith Luque Esparza
Principal Investigator
Instituto Mexicano del Seguro Social