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临床试验/NCT06685705
NCT06685705尚未招募4 期

Comparative Study Between Intrathecal Magnesium Sulfate, Neostigmine and Fentanyl As Adjuvant for Bubivacaine in Postoperative Analgesia in Lower Abdominal Surgeries

Assiut University0 个研究点目标入组 66 人开始时间: 2024年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
66
主要终点
first request of rescue analgesia

研究概览

简要总结

Lower abdominal surgeries often result in severe pain, which in turn can cause rapid and shallow breathing, retention of secretions and poor patient compliance. Justifiably, apart from the fear for the surgery outcome, patients are concerned mainly with postoperative pain. If treated inadequately, acute pain can have serious consequences for patient health mainly with postoperative complications, prolonged recovery and increased length of hospital stay. Higher levels of postoperative pain and pain distress are associated with increased morbidity, poorer functional recovery, and reduced quality of life.

Aim of the study To compare the duration, quality of analgesia, and side effects between intrathecal Magnesium sulfate, neostigmine and fentanyl as adjuvant for bubivacaine as postoperative analgesia in lower abdominal surgeries

详细描述

Effective analgesia aims to minimize patients stress response, pain intensity and distress, and side-effects of large single drug doses (typically an opioid). Numerous analgesic options exist for postoperative analgesia after abdominal surgery, including multiple classes of drugs and routes of administration e.g. parenteral, regional, neuraxial analgesia which include (epidural/intrathecal) techniques, truncal nerve blocks, and systemic drugs infusions.

Spinal anesthesia is a widely used technique in lower abdominal surgeries, offering several benefits such as allowing the patient to remain awake during the procedure, quick onset of action, high success rate, minimal drug dosage, effective sensory and motor blocks, and cost-effectiveness. However, despite these advantages, it can also cause side effects like hypotension, bradycardia, nausea, vomiting, and shivering.

Bupivacaine, is a commonly used local anesthetic, but its use can be limited by the duration of action and potential side effects. To enhance the analgesic effects and prolong the duration of bupivacaine, various adjuvants such as magnesium sulfate, neostigmine, and fentanyl are added intrathecally. Each adjuvant offers unique pharmacological properties that can influence spinal anesthesia's efficacy.

Magnesium sulfate, known for its N-methyl-D-aspartate (NMDA) receptor antagonist properties, decreases sensitivity to both central and peripheral pain stimuli by blocking calcium influx and reducing the excitability of NMDA receptors. Several studies have evaluated the role of magnesium sulfate (MgSO4) as an agent for pain control and reduction of analgesia requirement intra-and post-operatively. In some of these studies, researchers concluded that MgSO4 may reduce the need for opioid analgesic agents.

Neostigmine is a water-soluble, ionized compound that inhibits acetylcholinesterase (AChE). Its indication in FDA is to reverse the effect of non-depolarizing neuromuscular blockers after surgery. The drug is usually administered by intravenous injection, and the main route of excretion is the kidney. Neostigmine should be used with caution in patients with coronary heart disease, arrhythmia, recent acute coronary syndrome and myasthenia gravis. Neostigmine works by preventing the breakdown of the neurotransmitter acetylcholine. Recent studies suggest that this inhibition of acetylcholine degradation strengthens the descending modulation of afferent pain signals, offering a novel method for improving analgesia with minimal dose-related side effects. It enhances spinal cholinergic transmission, potentially increasing the analgesic effects without causing respiratory depression.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

patients will be randomly allocated into one of 3 study designed groups using serial number opaque closed envelopes.

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • the American Society of Anesthesiologists (ASA) classification I-II
  • Age >18 up to 55 years old
  • Patients who will undergo lower abdominal surgeries

排除标准

  • • Patients' refusal.
  • Patients with morbid obesity, cardiac diseases, hepatic diseases, renal diseases, diabetes mellitus with polyneuritis.
  • Patients who were in risk-scoring groups American Society of Anesthesia III-IV.
  • Hypertensive patients receiving therapy with adrenergic receptor antagonist, calcium channel blocker and/or angiotensin converting enzyme inhibitor.
  • Patients with coagulation disorders, those receiving any anticoagulants.
  • Any history of allergy to local anesthetic or other drugs used in the study, patients on examining drugs.
  • Any contraindication to spinal anesthesia ( infection at puncture site and increased intracranial tension and Patients with psychiatric illness and neurologic diseases.

研究组 & 干预措施

group 1

Experimental

patients will receive 15 mg of 0.5% hyperbaric bupivacaine + 50 mg Magnesium sulfate intrathecally.

干预措施: Magnesium Sulfate and Bupivacaine 0.125% (Drug)

group 2

Experimental

patients will receive 15mg of 0.5% hyperbaric bupivacaine + 50 µg Neostigmine intrathecally

干预措施: bupivacaine and Neostigmine (Drug)

group3

Experimental

patients will receive 15mg of 0.5% hyperbaric bupivacaine + 25µg of fentanyl intrathecally.

干预措施: fentanyl and bupivacaine (Drug)

结局指标

主要结局

first request of rescue analgesia

时间窗: baseline

The time of first request of rescue analgesia calculated from the time of spinal anesthesia.

次要结局

  • post operative VAS score(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohsen mohamed mohsen mahmoud

Resident at Anesthesia, Intensive Care and Pain Management Department South Egypt cancer Institute

Assiut University

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