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临床试验/NCT07022821
NCT07022821招募中4 期

Comparison of Different Doses of Dexmedetomidine in Combination With Ketamine for Control of Post-Operative Pain in Lower Segment Caesarean Section Surgeries

Fatima Memorial Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年5月16日最近更新:
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
90
试验地点
1
主要终点
Mean Postoperative Pain Score (Visual Analog Scale)

研究概览

简要总结

This study aims to compare three different doses of dexmedetomidine, when combined with a fixed dose of ketamine, for pain control in women undergoing cesarean section. The goal is to find the most effective combination with the fewest side effects.

详细描述

Caesarean section is associated with moderate-to-severe postoperative discomfort in a significant proportion of women, which can delay recovery and return to regular activities, disrupt mother-child bonding, affect maternal psychological well-being, and impede nursing. Furthermore, inadequate surgical pain treatment may result in hyperalgesia and chronic pain. Due to widespread misconceptions that analgesic medications or procedures may have detrimental effects on the mother or newborn, and because the severity of post-caesarean section pain is typically underestimated, pain following caesarean section is frequently under-treated.

Various analgesic therapy techniques include oral or parenteral opioids, nonsteroidal anti-inflammatory medications, and neuraxial blocks with or without adjuvants, with unclear efficacy and/or substantial adverse effects. While opioids are the gold standard for postoperative pain management, they are associated with respiratory depression, nausea, vomiting, and other adverse effects that increase patient suffering. In recent years, there has been a shift toward minimizing opioid use and developing guidelines for enhanced postpartum recovery. Studies have explored combining opioids with Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), ketamine, clonidine, and dexmedetomidine for effective pain relief while avoiding opioid-related side effects.

Dexmedetomidine, a highly selective α2-agonist, is beneficial in reducing tension and anxiety. It may be effective in the management of postoperative pain due to its analgesic properties. Dexmedetomidine acts at spinal and supraspinal sites, producing antinociceptive effects via stimulation of α2-receptors in the locus coeruleus.

Ketamine has been shown to be an effective painkiller with few side effects when used in small doses. Its analgesic effects result from N-methyl-D-aspartate (NMDA) receptor antagonism, and it also interacts with opioid receptors in the brain and spinal cord. When combined with benzodiazepines, ketamine's adverse effects are further minimized.

The combination of ketamine and dexmedetomidine offers several benefits, including hemodynamic stability, absence of respiratory depression, improved postoperative analgesia, and smoother recovery. Previous work has demonstrated a synergistic effect when these agents are used together, providing excellent symptom relief while minimizing side effects.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Elective lower segment cesarean section
  • American Society of Anesthesiologists (ASA) Physical Status II
  • Provided informed consent

排除标准

  • Known drug allergy
  • Presence of significant comorbidities
  • Emergency surgery
  • Documented psychiatric illness

研究组 & 干预措施

Low-Dose Dexmedetomidine

Experimental

Dexmedetomidine 0.2 µg/kg/hr + Ketamine 0.25 mg/kg/hr infusion

干预措施: Dexmedetomidine (Drug)

Low-Dose Dexmedetomidine

Experimental

Dexmedetomidine 0.2 µg/kg/hr + Ketamine 0.25 mg/kg/hr infusion

干预措施: ketamine (Drug)

Medium-Dose Dexmedetomidine

Experimental

Dexmedetomidine 0.3 µg/kg/hr + Ketamine 0.25 mg/kg/hr infusion

干预措施: Dexmedetomidine (Drug)

Medium-Dose Dexmedetomidine

Experimental

Dexmedetomidine 0.3 µg/kg/hr + Ketamine 0.25 mg/kg/hr infusion

干预措施: ketamine (Drug)

High-Dose Dexmedetomidine

Experimental

Dexmedetomidine 0.4 µg/kg/hr + Ketamine 0.25 mg/kg/hr infusion

干预措施: Dexmedetomidine (Drug)

High-Dose Dexmedetomidine

Experimental

Dexmedetomidine 0.4 µg/kg/hr + Ketamine 0.25 mg/kg/hr infusion

干预措施: ketamine (Drug)

结局指标

主要结局

Mean Postoperative Pain Score (Visual Analog Scale)

时间窗: 0-24 hours post-surgery

Pain will be assessed using the Visual Analog Scale (VAS), a 10-point scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate worse pain. Visual Analog Scale (VAS) scores will be recorded at 0, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively.

次要结局

  • Time to First Rescue Analgesia(Continuous monitoring up to 24 hours postoperative)
  • Total dose of rescue analgesia (Nalbuphine) required within 24 hours(24 hours postoperative)

研究者

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

Ahmed Naeem

Principal Investigator

Fatima Memorial Hospital

研究点 (1)

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