Interaction Between Intravenous Magnesium Sulfate and Volatile Anesthetics Compared to Propofol. A Three-center Prospective Randomized Single-blinded Electrophysiological Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change in TOF ratio after perfusion of magnesium
研究概览
简要总结
Magnesium and volatiles anesthetics both have an effect on the neuromuscular transmission. The primary objective of the study is to quantify the effect of a perfusion of intravenous magnesium on neuromuscular transmission measured by electromyography device TetraGraph device in patients undergoing general anesthesia with volatile anesthetics (desflurane, sevoflurane and isoflurane) as compared to intravenous anesthesia with propofol.
详细描述
Magnesium sulfate is regularly used during anesthesia, for instance for the reduction of postoperative pain. It reduces the liberation of acetylcholine at the neuromuscular junction. At high plasma concentrations it can induce muscle weakness, flaccid paralysis and in cases of intoxication lead to respiratory arrest. It enhances the effect of muscle relaxants.
Volatiles anesthetics influence neuromuscular transmission. They inhibit postsynaptic nicotinic acetylcholine receptors by causing open channel block, receptor desensitization and reducing exocytosis from pre-synaptic vesicles at the neuromuscular junction. The ranking order of these effects of volatile anesthetics on neuromuscular transmission is: desflurane > sevoflurane > isoflurane, depending on their blood-gas and tissue-gas solubility index.
Magnesium given intravenously during volatile anesthesia induces effects on neuromuscular transmission similar to that of neuromuscular blocking agents. This effect has never been investigated and quantified systematically and prospectively.
Propofol, an intravenous anesthetic, has very little effects on neuromuscular transmission. Therefore magnesium given intravenously during total intravenous anesthesia with propofol has no or only very little effect on neuromuscular transmission.
The primary objective of the study is to quantify the effect of a perfusion of intravenous magnesium on neuromuscular transmission measured by accelerometry with theTetraGraph device in patients undergoing general anesthesia with volatile anesthetics (desflurane, sevoflurane and isoflurane) as compared to intravenous anesthesia with propofol. The investigators expect a following rank order of the effect: desflurane > sevoflurane > isoflurane > propofol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
For practical reasons it is impossible to blind the investigator who conducts the anesthesia. However, the parameters of neuromuscular block are standardized, and study outcomes will be evaluated using the data stored and displayed in theTetraGraph Viewer software. All neuromuscular measurements of the study outcomes are reproducible and objective.
In contrast, the investigator evaluating the patient in the postanesthetic care unit and for the 24 h postoperative visit will be blinded to the study group allocation.
The patient will also be blinded to the study group allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients, age 18 to 65 years inclusive
- •American Society of Anesthesiology [ASA] status I or II
- •Body mass index 19 - 30 kg/m2
- •Patient scheduled for elective surgery lasting ≥ 60 minutes
- •Patient is able to read and understand the information sheet and to sign and date the consent form.
- •Negative urinary or serum pregnancy test (not applicable if status post hysterectomy or tubal ligation or menopausal woman)
排除标准
- •Surgery with need for neuromuscular block
- •Contraindication for general anesthesia with laryngeal mask airway, such as gastro-oesophageal reflux.
- •Hypersensitivity or allergy to magnesium sulfate or propofol
- •Contraindication to volatile anesthetics such as malignant hyperthermia
- •Patients with neuromuscular disease
- •Patients receiving medications known to influence neuromuscular function (for instance, aminoglycosides or phenytoine)
- •Known electrolyte abnormalities (for instance, hypermagnesemia)
- •Atrioventricular heart block
- •Patients with magnesium treatment within 48 hours before start of study
- •Liver insufficiency (bilirubine <1.5x, ALAT/ASAT<2.5x the upper limit of normal value)
- •Renal insuffisancy (créatinine <1.5x upper limit of normal value, clearance<30ml/minute)
- •Patient having participated in any clinical trial within 30 days, inclusive, of signing the informed consent form of the current trial.
- •Pregnant or breast-feeding women.
研究组 & 干预措施
Propofol
In all patients 3 minutes before induction sufentanil 0.2 mcg/kg or fentanyl 2 mcg/kg will be given.
In patients in the propofol group, anesthesia will be induced and maintained with a total intravenous anesthesia pump following the model of Schnider et al, at a targeted effect-site concentration of 4 +/- 1 mcg/ml.
In patients in all groups, after induction of anesthesia and loss of consciousness, a laryngeal mask airway will be inserted. The TetraGraph device will be calibrated. Once general anesthesia is established, a blood sample will be taken to measure serum magnesium and calcium levels. This blood sample will be analysed in the certified laboratory of each participating hospital.
干预措施: Magnesium Sulfate (Drug)
Isoflurane
In all patients 3 minutes before induction sufentanil 0.2 mcg/kg or fentanyl 2 mcg/kg will be given. After induction of anesthesia and loss of consciousness, a laryngeal mask airway will be inserted. The TetraGraph device will be calibrated. Once general anesthesia is established, a blood sample will be taken to measure serum magnesium and calcium levels. This blood sample will be analysed in the certified laboratory of each participating hospital.
The anesthesia will be maintained with the agent specified by randomization: isoflurane in this group.
干预措施: Magnesium Sulfate (Drug)
Desflurane
In all patients 3 minutes before induction sufentanil 0.2 mcg/kg or fentanyl 2 mcg/kg will be given. After induction of anesthesia and loss of consciousness, a laryngeal mask airway will be inserted. The TetraGraph device will be calibrated. Once general anesthesia is established, a blood sample will be taken to measure serum magnesium and calcium levels. This blood sample will be analysed in the certified laboratory of each participating hospital.
The anesthesia will be maintained with the agent specified by randomization: desflurane in this group.
干预措施: Magnesium Sulfate (Drug)
Sevoflurane
In all patients 3 minutes before induction sufentanil 0.2 mcg/kg or fentanyl 2 mcg/kg will be given. After induction of anesthesia and loss of consciousness, a laryngeal mask airway will be inserted. The TetraGraph device will be calibrated. Once general anesthesia is established, a blood sample will be taken to measure serum magnesium and calcium levels. This blood sample will be analysed in the certified laboratory of each participating hospital.
The anesthesia will be maintained with the agent specified by randomization: sevoflurane in this group.
干预措施: Magnesium Sulfate (Drug)
结局指标
主要结局
Change in TOF ratio after perfusion of magnesium
时间窗: After starting TOF AUTO mode. patients will receive an intravenous perfusion of magnesium 60mg/kg mg kg-1 over 5 minutes. Neuromuscular monitoring will be continued until the end of surgery, but at least until a TOF ratio of 0.9 is reached.
This primary outcome will be assessed with neuromuscular monitoring, carried out according to international guidelines. The ulnar nerve will be stimulated by train-of-four (TOF) using a TofScan monitor.
次要结局
- Lowest T1 twitch height and TOF ratio(After the perfusion of magnesium and until the T1 twitch height and the TOF ratio reach the initial values again.)
研究者
Christoph Czarnetzki
Consultant
University Hospital, Geneva