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临床试验/CTRI/2018/01/011509
CTRI/2018/01/011509已完成不适用

Effect of intravenous magnesium sulphate on block characteristics and post operative analgesia for inguinal hernia surgeries under spinal anaesthesia

JERRY JAME JOY1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年2月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
1.Duration of Analgesia

研究概览

简要总结

A prospective, randomized double blind clinical study was undertaken to evaluate the effects of intravenous magnesium sulphate on block characteristics and post operative analgesia for inguinal hernia surgeries under spinal anaesthesia.

Eighty patients were divided into two groups based on computer generated randomization code, each group consisting of forty patients. All the patients were given spinal anaesthesia with 10 mg of 0.5% hyperbaric bupivacaine (2ml) plus 25μg of fentanyl (0.5 ml).

Patients in Group A were administered a bolus dose of magnesium sulphate 30 mg/kg over 15 min, immediately after the administration of spinal drug and followed by an intravenous infusion 15 mg/kg/hr for 1 hour.

Patients in group B were administered a bolus of 50 ml of normal saline over 15 min, immediately after the administration of spinal drug followed by intravenous infusion of normal saline at the rate of 100 ml/hr for 1 hour.

All patients aged between 18 -55 years ,belonging to ASA class I and II posted for inguinal hernia surgery under spinal anesthesia were included in the study. Patients who had contraindication for spinal anaesthesia, history of allergy to test drugs, altered magnesium levels and significant cardiac, renal, respiratory, metabolic disorders were excluded from the study.

The parameters observed were

ï‚· Onset of sensory blockade

ï‚· Maximum level of sensory blockade.

ï‚· Onset of motor blockade.

ï‚· Duration of motor blockade.

ï‚· Duration of sensory blockade

ï‚· Duration of analgesia

ï‚· Haemodynamic parameters

It was found that there was no significant difference between the magnesium group and control group with regards to the onset of sensory and motor blockade, the maximum level of sensory blockade and the time taken to attain the maximum sensory level.

The duration of the sensory blockade was 192.45 ± 12.89 minutes in the magnesium group, and 167.37 ± 13.25 minutes in the control group. The difference of 25 minutes was statistically highly significant. The duration of analgesia was significantly prolonged being 267.37 ± 29.35 minutes in the magnesium group and 156.25 ± 14 minutes in the control group. The mean duration of the motor blockade was 161.72 ± 10.85 minutes in the magnesium group and 140.5 ± 11.36 minutes in the control group, which was highly statistically significant.

The serum magnesium levels were significantly higher in the magnesium group 24 hours after the surgery, being 0.86 ± 0.086 mmol/l and 0.82 ±0.076 mmol/l in the control group. But it may not be clinically significant as all the values were within the normal range.

The incidence of hypotension was comparatively more in the magnesium group but it was not statistically significant. Other adverse effects like respiratory depression, arrhythmias were not observed.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 未提供

排除标准

  • Patient refusal for the procedure ASA III & IV.
  • Age <18 & >55 years.
  • Contraindication to spinal anaesthesia.
  • History of allergy to test drugs.
  • Prior intake/supplementation of Magnesium for any reason Preoperative analgesic administration.

结局指标

主要结局

1.Duration of Analgesia

时间窗: 1.Time from intrathecal administration of drug to the time when patient complaints of pain at the surgical site or VAS score reaches greater than four

次要结局

  • 1.onset of sensory blockade(2.Onset of motor blockade)

研究者

发起方
JERRY JAME JOY
申办方类型
Other [self]

研究点 (1)

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