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临床试验/CTRI/2025/03/082280
CTRI/2025/03/082280尚未招募不适用

A prospective comparative study of effect of intravenous magnesium sulphate versus epidural magnesium sulphate on postoperative pain in patients undergoing laparoscopic gynecological oncologic surgeries

Dr Amrutha Arnepalli1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2025年3月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
106
试验地点
1
主要终点
To compare post operative pain using Visual Analogue Scale in both the study groups.

研究概览

简要总结

This is a prospective comparitive study of effect of intravenous magnesium sulphate over epidural magnesium sulphate in patients undergoing laparoscopic gynaecological oncological surgeries. Intravenous magnesium sulphate could be used as an alternativeto epidural as it requires less equipment , less cost and less tedious process. Group A patients will receive bolus of 10ml of 50mg/kg diluted form of intravenous magnesium sulphate prior to induction and will be started on 20mg/kg/hr magnesium sulphate intravenous infusion at the start of pneumoperitoneum. Group B will recieve bolus of 10 ml of 50mg/kg diluted form of magnesium sulphate epidurally and will be started on infusion of 20mg/kg/hr magnesium sulphate epidurally at the start of pneumoperitoneum and these infusions shall be continued till the end of surgery. Intraoperative haemodynamic parameters like heart rate, systolic and diastolic blood pressure, saturation, end tidal carbon dioxide levels, and first requirement of muscle relaxant will be recorded at the baseline,at time of study drug, intervals of 5min, 10min,15min, 30min intervals till end of procedure. Post operative pain scale using VAS score, requirement of rescue analgesic will be recorded immediatly after intubation, 30 min after intubation, hourly intervals till first 6 hours, 2hourly till 12hrs post procedure, and 24th hourly.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • Patients consenting for study
  • Patients having normal range of Serum magnesium levels.
  • ASA I and II patients
  • Female patients aged between 18-65 years.

排除标准

  • Patients who refuse epidural anaesthesia
  • Patients allergic to magnesium sulphate
  • Patients with known neuro muscular diseases, atrio ventricular conduction disturbances
  • Patients receiving treatment with calcium channel blockers or magnesium.

结局指标

主要结局

To compare post operative pain using Visual Analogue Scale in both the study groups.

时间窗: 24 Hours

次要结局

  • 1. To compare requirement of post operative rescue analgesia, intra operative muscle relaxants, intra operative haemodynamic parameters in both the study groups(24 hours)

研究者

发起方
Dr Amrutha Arnepalli
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr.Amrutha Arnepalli

Kidwai memorial institute of oncology

研究点 (1)

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