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临床试验/NCT06394375
NCT06394375已完成2 期

Effectiveness of Opioid Free Anesthesia Using Dexmedetomidine Inhibiting Nociception in Abdominal Laparoscopic Surgery

Indonesia University1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2023年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
74
试验地点
1
主要终点
Heart rate

研究概览

简要总结

Effectiveness of opioid free anesthesia using Dexmedetomidine to inhibit nociception in abdominal laparoscopic surgery

详细描述

Abdominal laparoscopic surgery is one of the most common procedures worldwide, commonly facilitated with opioid balanced anesthesia or regional anesthesia. Despite being a controversy, there are issues that suggest opioid to have an influence in tumor recurrence. The investigators performed general anesthesia without opioid in laparoscopic abdominal surgery, and compared the hemodynamic instability, total consumption of fentanyl rescue, qNOX score, Ephedrine intraoperative, and Numerical Rating Scale.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Allergy to dexmedetomidine
  • Heart rate < 60 or systolic blood pressure <100 mmHg
  • Severe cardiovascular, uncontrolled hypertension (stage 2) or hepatic or renal disorder
  • Pregnancy
  • Difficult airway
  • Drop out Criteria:
  • Intraoperative emergency
  • Convert to open laparatomy
  • Decided to withdraw from the study

研究组 & 干预措施

Opioid free anesthesia

Experimental

Patients in this group are given a combination of Dexmedetomidine, Lidocaine, Propofol, Sevoflurane, Rocuronium for induction and maintenance of general anesthesia. They are given rescue analgesia (fentanyl) when required, and Ephedrine as needed.

Patients were monitored using standard ASA monitoring and Connox.

Post operative pain score was assessed with NRS

干预措施: Dexmedetomidine (Drug)

Opioid balanced anesthesia

Active Comparator

Patients in this group are given a combination of Opioid (Fentanyl), Lidocaine, Propofol, Sevoflurane, Rocuronium for induction and maintenance of general anesthesia. They are given Ephedrine as needed.

Patients were monitored using standard ASA monitoring and Connox.

Post operative pain score was assessed with NRS

干预措施: Fentanyl (Drug)

结局指标

主要结局

Heart rate

时间窗: Intraoperative

Heart rate

Blood pressure

时间窗: Intraoperative

blood pressure, both systolic and diastolic measured with non invasive blood pressure monitoring

次要结局

  • Total consumption of Opioid(Intraoperative)
  • quantium nociception index (qNOX)(Intraoperative)
  • Ephedrine(intraoperative)
  • Pain score(24 hour)

研究者

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

Aida Rosita Tantri

Principal Investigator

Indonesia University

研究点 (1)

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