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临床试验/CTRI/2025/05/086920
CTRI/2025/05/086920尚未招募4 期

A comparative study of three different doses of magnesium sulphate as adjuvant with injection bupivacaine 0.5 percent heavy for infraumbilical procedures under subarachnoid block

Dr Apeksha Sureshbhai Prajapati1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年6月8日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
75
试验地点
1
主要终点
To see the duration and efficacy of magnesium sulphate as an adjuvant to bupivacaine heavy in Subarachnoid block

研究概览

简要总结

Regional Anesthesia in Lower Limb Surgeries:

Regional anesthesia, especially subarachnoid block (SAB), is preferred for lower limb surgeries over general anesthesia due to various benefits, such as:

Ease of administration

Dense sensory, motor, and sympathetic blockade

Better post-operative pain relief

Reduced incidence of postoperative nausea and vomiting (PONV)

Lower cost compared to general anesthesia

Reduced thromboembolism risk

Bupivacaine in SAB:

Bupivacaine is the most commonly used local anesthetic for SAB.

However, it has a limited duration of action, necessitating the use of adjuvants for prolonged effects.

Role of Adjuvants:

The use of adjuvants in SAB is gaining popularity for enhancing blockade duration, improving patient satisfaction, and achieving better surgical outcomes.

Adjuvants also provide prolonged analgesia, optimal resource utilization, and a higher success rate compared to general anesthesia.

Magnesium Sulfate as an Adjuvant:

Magnesium sulfate is an effective adjuvant for prolonging the duration of SAB.

It is a non-competitive antagonist of N-Methyl D-Aspartate (NMDA) receptors, preventing central sensitization from peripheral nociceptive stimulation.

Its antinociceptive properties contribute to prolonged pain relief, especially for postoperative pain management.

Safety of Magnesium Sulfate:

Magnesium sulfate has minimal adverse effects when used in low doses, making it a safe and beneficial addition to SAB for enhancing patient outcomes and reducing pain.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing subarachnoid block for infraumbilical surgeries 2) Patients aged 18 to 60 years 3) Patients of ASA â… , â…¡ and â…¢ grade.

排除标准

  • Patients refusal 2) Uncooperative patients 3) Patients with deformity of spine 4) Patients with coagulation disorder, thrombocytopenia, increased intracranial pressure, severe hypovolemia, severe heart disease, local infection at injection site, allergy to local anaesthetic.

结局指标

主要结局

To see the duration and efficacy of magnesium sulphate as an adjuvant to bupivacaine heavy in Subarachnoid block

时间窗: every 10 min for 120min till recovery for 2 months

次要结局

  • compare & evaluate the efficacy of a magnesium sulphate as an adjuvant in three different doses with inj Bupivacaine 0.5% heavy for spinal anaesthesia in terms of block characteristics haemodynamic parameters safety profile & post operative analgesia.(every 10 min for 120min till recovery for 2 months)

研究者

发起方
Dr Apeksha Sureshbhai Prajapati
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Apeksha Sureshbhai Prajapati

pdu college civil hospital rajkot

研究点 (1)

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