Effects of Intraoperative Magnesium Sulfate on Pain Relief, Hemodynamics and Quality of Recovery After Spine Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Analgesics consumption postoperatively in morphine equivalents
研究概览
简要总结
The treatment of postoperative pain is increasingly based on a multimodal approach and although opioids remain the drug of choice, they are often used in combination with other analgesics (paracetamol, cyclooxygenase inhibitors or non-steroidal anti-inflammatory drugs) and co-analgesic agents (clonidine and anti- NMDA such as ketamine or MgSO4). The rationale for combined analgesia is to achieve additive or synergistic analgesic properties while decreasing the incidence of side effects by reducing the dose of each agent. Nociceptive stimuli are known to activate the release of the excitatory amino acid glutamate in the dorsal horn of the spinal cord. The resultant activation of NMDA receptors causes calcium entry into the cell and triggers central sensitisation. This mechanism is involved in the perception of pain and mainly accounts for its persistence during the postoperative period.
Although magnesium is not a primary analgesic in itself, it enhances the analgesic actions of more established analgesics as an adjuvant agent. Magnesium produces a voltage-dependent block of NMDA receptors and has been reported to have analgesic properties that might be related to this inhibiting property. Magnesium sulfate has been reported to be effective in perioperative pain treatment and in blunting somatic, autonomic and endocrine reflexes provoked by noxious stimuli.
When magnesium was used intraoperatively, many researchers reported that it reduced the requirement for anesthetics and/or muscle relaxants.
Intraoperative use of magnesium sulfate can also be associated with decreased incidences of nausea and vomiting after surgery, which could have been due to the lower consumption of anesthetics (i.e. volatile agents), rather than any antiemetic effect of magnesium sulfate. In addition, perioperative i.v. administration of magnesium sulfate has another advantageous effect, as it decreases the incidence of shivering by up to 70-90%. Previous studies investigating the analgesic efficacy of MgSO4 in general, gynaecological, ophthalmic and orthopaedic surgery have shown conflicting results, while reports regarding spine surgery are extremely limited.
Our study was designed to investigate the effects of MgSO4 on perioperative pain relief and postoperative quality of recovery after lumbar laminectomy surgery.
详细描述
Each participant will receive standard monitoring (ECG, SpO2, capnography, SBP, oesophageal temperature, accelerography) and an intravenous access will be established. The level of anaesthesia will be monitored with the bispectral index (BIS), targeting to a BIS level 40-50.
Group M patients will receive intravenous magnesium sulfate 20 mg/kg over a 15-min period before induction of anaesthesia and 20 mg/kg/h by continuous i.v. infusion during the operation. Group C will be given isotonic solution of 0.9% in the same volume as the study drug.
A standard anesthesia protocol will be applied involving propofol 2mg/kg (iv) and fendanyl 2 μg/kg (iv). Cis-atracurium 0.2 mg/kg (iv) will be given to facilitate endotracheal intubation. Anaesthesia will be maintained with air 50% and oxygen 50%, and desflurane adjusted to achieve a target BIS between 40 and 50. Remifentanil will be added to the anesthesia regimen as needed.
Hemodynamic parameters will be recorded upon
- Baseline: Before the administration of the tested drug
- T5: 5 minutes after the administration of the tested drug
- T10: 10 minutes after the administration of the tested drug
- T15: 15 minutes after the administration of the tested drug
- Ts: surgical incision
- T30: 30 minutes after the administration of the tested drug
- T45: 45 minutes after the administration of the tested drug
- T60: 60 minutes after the administration of the tested drug
- T90: 90 minutes after the administration of the tested drug
- T120: 120 minutes after the administration of the tested drug
- T180: 180 minutes after the administration of the tested drug
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged between 18 and 80 years
- •ASA Physical status 1 to 3
- •Elective or semi-elective lumbar laminectomy surgery
- •Signed informed consent
排除标准
- •Under medication with calcium channel blockers or magnesium
- •Drugs or alcohol abuse
- •Neurological disorders
- •Intracardiac block
- •Hepatic failure
- •Renal failure
- •Pregnancy
研究组 & 干预措施
Magnesium sulfate
Magnesium sulfate 20 mg/kg intravenous over a 15-min period before induction of anesthesia and 20 mg/kg/h by continuous i.v. infusion until surgery completion.
干预措施: Magnesium Sulfate (Drug)
Magnesium sulfate
Magnesium sulfate 20 mg/kg intravenous over a 15-min period before induction of anesthesia and 20 mg/kg/h by continuous i.v. infusion until surgery completion.
干预措施: Isotonic saline 0.9% (Drug)
Isotonic solution 0.9%
Isotonic solution 0.9% in the same volume as the study drug using identical pattern of administration.
干预措施: Magnesium Sulfate (Drug)
Isotonic solution 0.9%
Isotonic solution 0.9% in the same volume as the study drug using identical pattern of administration.
干预措施: Isotonic saline 0.9% (Drug)
结局指标
主要结局
Analgesics consumption postoperatively in morphine equivalents
时间窗: 24 hours after the emergence from anesthesia
The difference in analgesic consumption (assessed as mg of morphine equivalents) postoperatively after intravenous infusion of magnesium sulfate or isotonic saline 0.9%
次要结局
- Time to first analgesic request in minutes(24 hours after the emergence from anesthesia)
- Analgesics consumption intraoperatively(180 minutes intraoperatively)
- Pain intensity(10 minutes after emergence from anesthesia, 2, 4 and 6 hours after the emergence from anesthesia)
研究者
Georgia Tsaousi
Assistant Professor
Aristotle University Of Thessaloniki