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临床试验/NCT07395271
NCT07395271已完成4 期

Comparing Doses of Intrathecal Dexmedetomidine Along With Bupivacaine for Cesarean Section: A Double-Blind Randomized Clinical Trial

Bahria International Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月22日最近更新:
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Duration of sensory blockade

研究概览

简要总结

To compare the duration of sensory and motor blockade produced by two different intrathecal doses of dexmedetomidine (5 µg and 10 µg) when added to hyperbaric bupivacaine in patients undergoing elective cesarean section

详细描述

Cesarean section remains one of the most commonly performed surgical procedures worldwide, serving as a critical intervention to reduce maternal and neonatal morbidity when vaginal delivery poses increased risks. Global cesarean delivery rates have risen steadily, from approximately 7% in 1990 to around 21% in recent years, with projections indicating that by 2030, nearly one in three births may occur via cesarean section .This trend is particularly pronounced in regions like Latin America and the Caribbean (over 40%) and varies significantly by socioeconomic factors, healthcare access, and clinical indications . In Pakistan and similar settings, rates continue to increase, underscoring the need for optimized anesthetic techniques that prioritize maternal safety, fetal well-being, rapid recovery, and effective postoperative pain control.

Regional anesthesia, specifically spinal anesthesia, is the preferred method for elective cesarean sections due to its rapid onset, avoidance of airway complications associated with general anesthesia, minimal placental transfer of drugs, and enhanced maternal satisfaction. Hyperbaric bupivacaine is the most widely used local anesthetic for this purpose, providing reliable sensory and motor blockade. However, when used alone, bupivacaine offers relatively short-duration postoperative analgesia, which can delay ambulation, hinder early mother-infant bonding, and increase the need for systemic analgesics6. To address these limitations, various intrathecal adjuvants have been investigated to enhance block quality, prolong analgesia, and improve overall outcomes.

Dexmedetomidine, a highly selective α2-adrenergic agonist, exhibits sedative, anxiolytic, and analgesic properties without significant respiratory depression. When administered intrathecally, it inhibits nociceptive transmission through presynaptic C-fibers and postsynaptic dorsal horn neurons, resulting in prolonged sensory and motor blockade compared to bupivacaine alone8,9 . Multiple recent studies and meta-analyses have confirmed its efficacy as an adjuvant in obstetric spinal anesthesia, demonstrating extended analgesia duration, reduced shivering, and fewer side effects (e.g., pruritus, nausea) than opioids like fentanyl . However, the optimal intrathecal dose remains controversial: lower doses (e.g., 3-5 µg) may offer a favorable benefit-risk profile with minimal hemodynamic impact, while higher doses (e.g., 10 µg) provide greater prolongation but raise concerns about potential bradycardia or hypotension in parturient.

This prospective, double-blind, randomized clinical trial compares the effects of two commonly used doses of intrathecal dexmedetomidine-5 µg and 10 µg-when added to a standard dose of hyperbaric bupivacaine (12.5 mg) for elective cesarean section. The primary aim is to determine which dose yields superior prolongation of sensory and motor blockade while maintaining maternal hemodynamic stability and safety.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Parturients aged 20-40 years
  • ASA physical status II
  • Scheduled for elective cesarean section
  • Ability to provide informed written consent

排除标准

  • ASA physical status III or higher
  • Emergency cesarean section
  • Previous labor analgesia
  • History of cardiovascular, neurological, or systemic disease
  • Contraindications to spinal anesthesia
  • Surgery duration exceeding 60 minutes

研究组 & 干预措施

Group A

Active Comparator

Dexmedetomidine 5 mcg

干预措施: Dexmedetomidine 5 mcg (Drug)

Group B

Active Comparator

Dexmedetomidine 10 mcg

干预措施: Dexmedetomidine 10 mcg (Drug)

结局指标

主要结局

Duration of sensory blockade

时间窗: 6 hrs

Visual Analouge Scale (0 to 10)

Duration of motor blockade

时间窗: 6 hrs

Bromage Scale (1 to 5)

次要结局

  • Hemodynamic parameters(Till end of surgery)

研究者

发起方
Bahria International Hospital
申办方类型
Unknown
责任方
Principal Investigator
主要研究者

Azher Munir

Principal Investigator, Postgraduate Resident

Bahria International Hospital

研究点 (1)

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