跳至主要内容
临床试验/NCT03393403
NCT03393403Unknown不适用

Comparison of the Effect of Intravenous Continuous Dexmedetomidine Infusion and Dexmedetomidine as a Local Anesthetic Adjuvant in Subcostal Transverse Abdominis Plane Block in Patients Undergoing Gastric Cancer Surgery

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年12月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
90
试验地点
1
主要终点
analgesic effect - pain intensity

研究概览

简要总结

Using random case assignment to investigate the analgesic and sedative effect of intravenous dexmedetomidine and dexmedetomidine as a local anesthetic adjuvant in ultrasound-guided subcostal TAP block in gastric cancer patient undergoing gastrectomy or partial gastrectomy.

详细描述

The process of the experiment (brief describe) The participant patients will be randomly allocated into three groups: the intravenous dexmedetomidine group (Dex_iv group), dexmedetomidine adding to local anesthetic as an adjuvant for subcostal TAP block (Dex_adj group), and Control group. All patients receive gastrectomy or partial gastrectomy in general anesthesia as standard. Thirty minutes before the end of surgery, the patients in Dex_iv group receive 0.5mcg/kg dexmedetomidine infusion for 30 minutes, while the patients in Dex_adj group and control group receive 0.125ml/kg 0.9% normal saline IV infusion for 30 minutes. All patients have ultrasound-guided TAP block single injection after the end of surgery and before the tracheal tube extubation. The block agents in Dex_adj group is 40 ml of 0.375% ropivacaine with 0.5mcg/kg dexmedetomidine, while in Dex_iv group and control group are only 40ml of 0.375% ropivacaine. The IV PCA pump will be set up before patients awaken in the post-anesthesia care unit. All patients are assessed for the signs of emergence agitation with Riker sedation-agitation scale in the post-anesthesia care unit. The numerical rating scale (NRS) for pain intensity assessment, the opioid consumption via IV PCA pump, and the patients satisfaction will be documented for postoperative 3 days for the impact evaluation of dexmedetomidine in postoperative analgesia in patients undergoing gastric cancer surgery with subcostal TAP block.

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, Care Provider)

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • gastric cancer patients undergoing gastrectomy or partial gastrectomy, who receive ultrasound-guided subcostal TAP block and PCA for postoperative analgesia

排除标准

  • surgery involved other visceral organ (eg. combined splenectomy or partial hepatectomy), patients with histories of adverse drug reaction to dexmedetomidine, bradycardia (baseline heart rate <60 beats/min), any type of atrioventricular block in electrocardiogram (EKG), heart failure, significant renal or hepatic impairment, severe bronchopulmonary disease, any coagulant disorder, and pregnant or breast-feeding woman.

研究组 & 干预措施

Dexmedetomidine_iv group

Experimental

Dexmedetomidine 0.5mcg/kg (diluted in normal saline) intravenously infusion for 30min

干预措施: Dexmedetomidine (Drug)

Dexmedetomidine_adj group

Experimental

Dexmedetomidine 0.5mcg/kg (adding to local anesthetic) perineural single bolus for subcostal TAP block 0.9% sodium chloride 0.125ml/kg intravenously infusion for 30min

干预措施: Dexmedetomidine (Drug)

Dexmedetomidine_adj group

Experimental

Dexmedetomidine 0.5mcg/kg (adding to local anesthetic) perineural single bolus for subcostal TAP block 0.9% sodium chloride 0.125ml/kg intravenously infusion for 30min

干预措施: 0.9% Sodium-chloride (Drug)

Control group

Active Comparator

0.9% sodium chloride 0.125ml/kg intravenously infusion for 30min No dexmedetomidine use

干预措施: 0.9% Sodium-chloride (Drug)

结局指标

主要结局

analgesic effect - pain intensity

时间窗: postoperative 3 days

postoperative acute pain intensity (numerical rating scale, NRS, 0-10)

次要结局

  • sedative effect(postoperative 2 hours)
  • analgesic effect - opioid consumption(postoperative 3 days)

研究者

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

KMUHIRB-F(II)-20170001

Physician

Kaohsiung Medical University Chung-Ho Memorial Hospital

研究点 (1)

Loading locations...

相似试验

Comparison of the Effect of Intravenous and... | 临床试验