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临床试验/NCT04600089
NCT04600089招募中2 期

A Randomized, Double-blind, Placebo-controlled, Study to Identify the Opioid-sparing Effects, and Pain-reduction Potential of Low Dose Ketamine on Patients Undergoing TEVAR Procedures Receiving NCI

Sam Tyagi1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年12月8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
招募中
发起方
入组人数
30
试验地点
1
主要终点
Cumulative Opioid Dose

研究概览

简要总结

The objective of this study is to identify the opioid-sparing effects, and pain-reduction potential of low dose, sub-dissociative ketamine on patients undergoing thoracic endovascular aortic repair (TEVAR) procedures receiving naloxone continuous infusion (NCI).

详细描述

Patients undergoing descending aortic repair often experience post-operative pain, and have high post operative opioid requirements. That pain is partially due to the use of naloxone continuous infusion (NCI). NCI is part of a bundled approach used in the first 48 hours post-operatively to prevent spinal cord ischemia, a devastating complication associated with surgical repair of the descending aortic. Data indicate that patients receiving NCI experience elevated post-operative pain scores and increased opioid requirements during the 48-hr post-operative NCI administration, compared to patients not receiving NCI.

Ketamine is an FDA-approved N-methyl D-aspartate (NMDA) antagonist that has been shown to provide adjunctive analgesia and opioid-sparing effects in post-operative surgical patients. At low doses, ketamine provides analgesic benefit without the anesthetic effects seen at higher doses. These doses are commonly referred to sub-dissociative. This study will evaluate whether use of sub dissociative ketamine (SDK) in patients undergoing aortic procedures with the use of NCI will lead to decreased post-operative opioid consumption, and produce improved pain scores in the first 48 hours.

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
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • willing to give informed consent
  • scheduled for elective thoracic aorta repair or thoracoabdominal aortic repair
  • requires naloxone continuous infusion for spinal prophylaxis

排除标准

  • allergy to ketamine, acetaminophen, or fentanyl
  • diagnosis of schizophrenia
  • history of hydrocephalus or central nervous system mass
  • incarcerated individuals
  • pregnant or lactating individuals

研究组 & 干预措施

Standard of Care

Placebo Comparator

Participants in this group will receive standard of care as well as a saline infusion during the study period.

干预措施: Saline (Drug)

Sub-Dissociative Ketamine

Experimental

Participants in this group will receive standard of care as well as a continuous ketamine infusion at the induction of anesthesia and for 48 hours postoperatively.

干预措施: Ketamine (Drug)

结局指标

主要结局

Cumulative Opioid Dose

时间窗: 48 hours

Total morphine milligram equivalents (MME) will be assessed every 6 hours for 48 hours.

次要结局

  • Change in Pain(48 hours)
  • Number of Patients with Ketamine-Induced Delirium(48 hours)
  • Number of Patients with Uncontrolled Hypertension(48 hours)

研究者

发起方
Sam Tyagi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sam Tyagi

Assistant Professor

University of Kentucky

研究点 (1)

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