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临床试验/CTRI/2024/03/063906
CTRI/2024/03/063906尚未招募不适用

Comparison of Dexmedetomidine with Magnesium sulphate as an additional adjuvant to intrathecal Bupivacaine and Morphine combination for post operative analgesia in patients undergoing major abdominal Surgeries. A Prospective randomized double blind study.

未提供1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
To evaluate and compare the total morphine consumption between two groups in the first 24 hrs and second 24 hrs following surgery.

研究概览

简要总结

Pain is an important hindrance to recovery from surgery and anaesthesia in the post-operative period.

Poorly managed postoperative pain after any surgery can impair surgical outcomes. it may become chronic pain . it can result in a prolonged duration of the hospital stay.

It can lead to more severe complications such as atelectasis, respiratory infection, myocardial infarction, and even bad surgical outcome or deathand thus it increases overall costs for society .

Adequate pain management is one of the most important factors in expediting recovery, by enabling fast mobilization.

Major abdominal incisions are commonly associated with persistent post-operative pain, in particular affecting respiratory function and also associated with increased analgesic requirement.

Effectively administered analgesia enables greater patient satisfaction by minimizing acute postoperative pain.

Through alleviating the acute physiological stress response to surgery it facilitates enhanced recovery outcomes including early mobilisation and return to normal activity, reduced length of hospital stay, and reduced cardiac, respiratory and gastrointestinal postoperative complications leading to improved long-term patient survival rates.

Opioids remain the main stay of treatment in these situations where there will be a continuous noxious stimulus from the incision site because of the ongoing respiratory excursions. Even though opioids are the most effective forms of medication that are being used in relieving pain ,they are associated with severe systemic side effectsand potential risk of addiction. Therefore, a general goal is to minimize exposure to the side effects of prolonged systemic narcotics while ensuring adequate analgesia.

This can be achieved with a multimodal approach combining regional anaesthesia, centrally-acting analgesics such as paracetamol, and drugs with a peripheral nonsteroidal anti-inflammatory effect  to minimize the opioid-related side effects while maintaining an effective level of pain control.

To evaluate and compare the total morphine consumption between two groups in the first 24 hrs and second 24 hrs following surgery.

The current study is designed to evaluate and compare the usefulness of Dexmedetomidine or magnesium sulphate as an additional adjuvant to a combination of intrathecal bupivacaine  and morphine for post operative analgesia in major abdominal surgeries.

研究设计

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

入排标准

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

入选标准

  • 1.Patients Aged 18-65years.
  • 2.Patients belonging to American society of anaesthesiologists (ASA PS) physical status grade I, II and III .
  • 3.Patients scheduled to undergo major abdominal surgeries with expected duration of 3 to 4 hrs and 4.Patients willing to give the written consent to participate in the study will be included in the study.

排除标准

  • Patients who are not willing to participate in the study.
  • Patients with history of intolerance or showing anaphylactic reaction to the medications used in the study.
  • Patients with severe hepatic, renal, cardiac and neurological disorders.
  • Pregnant and lactating women.
  • Patients who cannot understand or interpret VAS for pain assessment and Patients who could not be positioned for regional technique post-surgery will be excluded from the study.

结局指标

主要结局

To evaluate and compare the total morphine consumption between two groups in the first 24 hrs and second 24 hrs following surgery.

时间窗: 24hrs and 48hrs

次要结局

  • 1.To assess the magnitude of pain by visual analogue Scale (VAS) at different points of time.(2.To assess sensory block by Hollmen scale.)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr. Janaki subhdra peyyety

Sri venkateswara institute of Medical sciences

研究点 (1)

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