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临床试验/NCT07238101
NCT07238101已完成4 期

Hemodynamic Effects of Fentanyl and Dexmedetomidine in Spine Surgery

Universitas Sumatera Utara1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年5月8日最近更新:
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Change in Mean Arterial Pressure (MAP) during spinal surgery

研究概览

简要总结

Researchers will compare dexmedetomidine to fentanyl to see which drug provides better hemodynamic stability during spinal surgery.

Participants will :

  • Receive either dexmedetomidine or fentanyl as part of their anesthesia during elective surgery
  • Have their mean arterial pressure and heart rate measured at several time points during the procedure
  • Be monitored throughout surgery to assess intraoperative hemodynamic responses and stability

详细描述

Spinal surgery is frequently associated with perioperative hemodynamic fluctuations and significant postoperative pain. Maintaining stable intraoperative blood pressure and heart rate is essential to minimize surgical bleeding, protect neural structures, and promote optimal recovery. Dexmedetomidine, a highly selective α₂-adrenergic receptor agonist, provides sedation, analgesia, and sympatholytic effects without causing respiratory depression and may contribute to improved cardiovascular stability during anesthesia. Fentanyl, a potent synthetic opioid, is widely utilized as an analgesic adjunct in general anesthesia but may offer less consistent hemodynamic control.

This study is a prospective, interventional, randomized, double-blind controlled trial conducted at Adam Malik General Hospital, Medan, Indonesia, following approval from the institutional ethics committee. A total of 50 adult patients scheduled for elective spinal surgery under general anesthesia were enrolled using consecutive sampling and randomly assigned to receive either dexmedetomidine or fentanyl as part of intraoperative management.

Eligible participants were aged 17-60 years and classified as American Society of Anesthesiologists (ASA) physical status I-III. Patients with known drug hypersensitivity, significant cardiac or vascular abnormalities, or contraindications to the study drugs were excluded.

Hemodynamic parameters, including mean arterial pressure (MAP) and heart rate, were recorded at baseline (T0) and at predetermined intraoperative time points (T1-T12). The primary outcome measure was intraoperative MAP, while secondary outcomes included heart rate and estimated blood loss. Statistical analyses were performed using independent t-tests or Wilcoxon rank-sum tests, with a significance threshold of p < 0.05.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
17 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 17 and 60 years old
  • Classified as ASA physical status 1-3
  • Scheduled for elective spinal surgery
  • Provided written informed consent

排除标准

  • History of drug hipersensitivity to fentanyl or dexmetomidine
  • Presence of Cardiac Anatomical abnormalities
  • Vsacular disorders or other conditions that may interfere with the study

研究组 & 干预措施

Dexmedetomidine Group

Experimental

Participants in this group received dexmedetomidine at a dose of 0.5 μg/kgBW/hour intravenously as part of anesthesia management for spinal surgery. The purpose is to evaluate the effect of dexmedetomidine on hemodynamic stability, including heart rate and mean arterial pressure, during and after induction of anesthesia.

干预措施: Dexmedetomidine (Drug)

Fentanyl Group

Experimental

Participants in this group received fentanyl at a dose of 1.5 μg/kgBW/hour intravenously as part of anesthesia management for spinal surgery. This arm serves as the comparison group to evaluate differences in hemodynamic parameters such as heart rate and mean arterial pressure compared to dexmedetomidine.

干预措施: fentanyl (Drug)

结局指标

主要结局

Change in Mean Arterial Pressure (MAP) during spinal surgery

时间窗: MAP will be recorded at baseline (T0), and at 5, 10, 15, 20, 25, 30, 60, 120, 180, and 240 minutes after drug administration

Measurement of mean arterial pressure (MAP) at multiple time points to compare the effects of dexmedetomidine versus fentanyl on intraoperative hemodynamic stability during spinal surgery.

次要结局

  • Change in Heart Rate (Pulse) during spinal surgery(Heart rate will be recorded at the same time points as MAP: baseline (T0), and at 5, 10, 15, 20, 25, 30, 60, 120, 180, and 240 minutes after drug administration)

研究者

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

Ida Julita

dr

Universitas Sumatera Utara

研究点 (1)

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