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临床试验/NCT06310850
NCT06310850已完成3 期

The Effect of Preprocedural Subanesthetic Ketamine for Pain and Anxiety in Patients During Thoracic Epidural Catheterization: A Randomized Trial

Ankara Ataturk Sanatorium Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Visual analog scale (VAS)

研究概览

简要总结

The thoracic epidural catheterization (TEC) can be both uncomfortable and fearful for patients when done awake with the thought that the procedure may be painful. The aim of this study was to assess the effect of subanesthetic intravenous ketamine administration on pain and anxiety during the TEC procedure.

详细描述

The study aimed to assess the impact of subanesthetic intravenous ketamine administration on pain and anxiety during Thoracic Epidural Catheterisation (TEC) procedure, which can be uncomfortable and frightening for patients when performed awake due to the possibility of pain.

After receiving approval from the clinical research ethics committee of Keçiören Education and Research Hospital (KEAH; ID:238), this prospective and randomized study will include 60 adult patients with ASA physical status I-III who are scheduled for elective thoracic surgery via thoracotomy. The study will randomly assign patients into two groups: Group P (n=30) receiving an intravenous placebo and Group K (n=30) receiving intravenous (IV) 0.15 mg kg-1 ketamine. Randomisation will be performed using a computerised table of random numbers.

Patients with chronic pain, bleeding disorders, drug use, liver disease, severe metabolic and endocrine problems, a history of ketamine or local anaesthetic allergy, infection at the site of intervention, or refusal of TEC will be excluded. Patients who report acute pain during preoperative evaluation, have a TEC time of more than five minutes (from needle insertion to catheter insertion), and require more than two Tuohy needle attempts will be excluded. Vital parameters and anxiety levels of each patient will be recorded before premedication. Anxiety (VAS-A) and pain (VAS-P) scores will be measured using the visual analogue scale. Patients will be transported to the operating theatre 20 minutes after premedication. Intravenous administration of 0.15 mg/kg IV ketamine or placebo will take place 3 minutes before TEC placement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • Patients who underwent elective thoracic surgery via thoracotomy
  • Patients with ASA physical status I-III

排除标准

  • Describing chronic pain,
  • Have a bleeding disorder,
  • Having a history of analgesia drug use,
  • Have a history of liver disease,
  • Have serious metabolic and endocrine problems,
  • Have a history of allergy to ketamine and local anesthetics,
  • Have an infection in the intervention area,
  • Rejecting thoracic epidural catheter,
  • Describing acute pain in any part of the body during the preoperative evaluation,
  • Thoracic epidural catheter duration greater than five minutes (time from needle entry to catheter placement)
  • Patients requiring more than two Tuohy injection attempts

研究组 & 干预措施

Group Placebo

Placebo Comparator

intravenous placebo

干预措施: Placebo (Other)

Group Ketamine

Active Comparator

intravenous ketamine 0.15 mg kg-1

干预措施: Ketamine (Drug)

结局指标

主要结局

Visual analog scale (VAS)

时间窗: 1 day (5 times)

For anxiety, on a 100 mm scale, 0 mm was defined as no anxiety, whereas 100 mm was as unbearable anxiety (VAS-A). A similar scoring method was used to assess pain intensity. 0 mm was defined as no pain and 100 mm as unbearable pain (VAS-P).

次要结局

未报告次要终点

研究者

发起方
Ankara Ataturk Sanatorium Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Onur Kucuk

Principal Investigator

Ankara Ataturk Sanatorium Training and Research Hospital

研究点 (1)

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