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临床试验/NCT05826119
NCT05826119已完成不适用

The Effect of Intravenous Magnesium Sulfate Use on Intraoperative Remifentanil Consumption and Postoperative Pain in Laparoscopic Hysterectomy Cases

Ondokuz Mayıs University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Fentanyl consumption in the first 24 hours after surgery

研究概览

简要总结

In our study, it was aimed to show the contribution of intraoperative intravenous magnesium sulfate administration to peroperative opioid consumption and postoperative analgesia.

详细描述

Postsurgical pain is one of the most important issues that could impress on postoperative peace and comfort. Laparoscopic hysterectomy associated with intense inflammatory response, resulting in moderate to severe postoperative pain perception The major goal in postoperative pain management is to minimize the dose of medications and lessen side effects, while still providing adequate analgesia. Postoperative pain relief leads to earlier mobilization, shortened hospital staying, reduced hospital costs, and increased patient satisfaction Narcotics are the most common analgesics which are used after the surgeries. But anesthetists are always looking for replaceable methods with fewer side effects and cost . It seems adjuvant analgesics are those desirable replacements. Nowadays there have been many debates on the role of adjuvant analgesics on postoperative pain relief. One way to use adjuvant analgesics is preventive method Preventive analgesia is a method initiated before anesthetic procedure in order to reduce the physiological consequences of nociceptive stimulation and medical adverse effects and has been defined as an antinociceptive treatment that prevents establishment of altered central processing of afferent input from injuries. One of the intravenous adjuvant that has been shown potential in preventive analgesia is magnesium sulfate that could be administered with multiple routes or methods Mg has been used for many years in anesthesia and cardiology as an anticonvulsant or antiarrhythmic drug. The mechanism of the analgesic effect of Mg is not clear but interference with calcium channels and N-methyl-D-aspartate (NMDA) receptor seem to play an important role. It seems that analgesic mechanism of NMDA-antagonists is made by preventing nociceptive central sensitization. Another suggesting mechanism is the role of it on reduction of catecholamine release with sympathetic stimulation, thereby decreasing peripheral nociception or the stress response to the surgery. Data illustrate that the NMDA receptor antagonists "like Mg sulfate" have an effect on pain threshold and could prevent pain perception even with low doses (preventive doses) In our study, investigators aimed to determine the contribution of magnesium sulfate to postoperative analgesia in abdominal hysterectomy by considering its mechanism of action.

The patients were divided into two groups as magnesium sulfate administered and non-administered The magnesium group received a bolus of 20 mg/kg of magnesium sulfate in 100 mL of saline for 15 minutes before induction, followed by a continuous infusion of 20 mg/kg/hr until the skin was closed. The same volume of isotonic saline for the control group was administered as indicated in the magnesium group.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient undergoing abdominal hysterectomy
  • Between the ages of 20-70,
  • ASA I- II

排除标准

  • Presence of hepatic and renal dysfunction,
  • Presence of cardiac arrhythmia or other cardiac comorbidity,
  • Neurological and psychiatric disorder,
  • Chronic use of calcium and beta blockers,
  • Drug or alcohol abuse,
  • Pregnancy and lactation status,
  • Patients with a history of allergy to any drug included in the study protocol

研究组 & 干预措施

Magnesium sulfate

Active Comparator

Before induction, a bolus of 20 mg/kg magnesium sulfate in 100 mL saline was administered for 15 minutes, followed by a continuous infusion of 20 mg/kg/hour until the skin was closed.

干预措施: magnesium sulfate group (Drug)

Placebo

Active Comparator

The control group received only 100 ml of saline 15 minutes before induction.

干预措施: Placebo (Drug)

结局指标

主要结局

Fentanyl consumption in the first 24 hours after surgery

时间窗: Postoperative Day 1

Fentanyl consumption in the first 24 hours was measured. Patients were able to request opioids via a PCA device when their VAS score is above 4 at rest and during activity (coughing and walking).

次要结局

  • The incidences of post-operative nausea and vomiting (PONV)(Postoperative Day 1)
  • Post-operative acute pain(Postoperative Day 1)

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilke Tamdogan

Principal Investigator

Ondokuz Mayıs University

研究点 (1)

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