Ketamine and Dexametasone in the Management of Pain in Lumbar Arthrodesis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Efficacy of Morphic Chloride (PCA) to treat pain during the post-operative period. Consumption of morphics will be evaluated
研究概览
简要总结
KETAMINE AND DEXAMETASONE IN THE MANAGEMENT OF PAIN IN LUMBAR ARTHRODESISPhase IV prospective randomized controlled single-center clinical trial to determine the effect of intravenous ketamine and dexamethasone administration perioperatively in patients undergoing lumbar arthrodesis.
详细描述
The need to carry out this study is to evaluate the analgesic effects after the administration of ketamine and dexamethasone intravenously perioperatively in patients undergoing lumbar arthrodesis and, likewise, study the incidence of pain and protocolize perioperative analgesia.
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, Investigator)
盲法说明
To preserve the masking of the study, the randomization system has been carried out by the pharmacy service personnel using the EPIDAT 4.0 program and only the personnel responsible for the pharmacy will know the randomization tables and codes. The main investigator will have the emergency codes in case of need by contacting the pharmacy service
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Age> 18 years
- •ASA I-III.
- •Lumbar arthrodesis.
- •Patients who have signed the preoperative informed consent for participation in the study.
排除标准
- •Unstable coronary heart disease
- •History of allergy to ketamine, dexamethasone, or morphic chloride
- •Dementia or inability to understand IC and study
- •Pluricomplicated diabetes mellitus difficult to control
- •Patients who have taken an experimental drug 30 days before the start of the study or who are included in any type of study of an experimental drug
研究组 & 干预措施
Ketamina bolus plus Dexamethasone bolus plus infusion ketamine
Ketamine bolus (0.5 mg / kg) + dexamethasone 0.1 mg / kg bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the Post-Anesthesia Resuscitation Unit (URPA)
干预措施: Ketamine (Drug)
Ketamina bolus plus Dexamethasone bolus plus infusion ketamine
Ketamine bolus (0.5 mg / kg) + dexamethasone 0.1 mg / kg bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the Post-Anesthesia Resuscitation Unit (URPA)
干预措施: Dexamethasone (Drug)
Ketamine bolus plus ketamine infusion
Ketamine bolus (0.5 mg / kg) + physiological serum bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the URPA.
干预措施: Ketamine (Drug)
Ketamine bolus plus ketamine infusion
Ketamine bolus (0.5 mg / kg) + physiological serum bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the URPA.
干预措施: Physiologic saline (Drug)
Dexametasone arm
Saline bolus + dexamethasone bolus 0.1 mg / kg + saline infusion up to three hours after admission in URPA
干预措施: Dexamethasone (Drug)
Dexametasone arm
Saline bolus + dexamethasone bolus 0.1 mg / kg + saline infusion up to three hours after admission in URPA
干预措施: Physiologic saline (Drug)
Saline bolus
Saline bolus + saline bolus + saline infusion up to three hours after admission to the URPA
干预措施: Physiologic saline (Drug)
结局指标
主要结局
Efficacy of Morphic Chloride (PCA) to treat pain during the post-operative period. Consumption of morphics will be evaluated
时间窗: 4 hours post operative
Consumption of morphics
次要结局
- Incidence of postoperative nausea and vomiting (PONV).(4 hours post operative)
- Efficay of study treatment regarding pain at 3 postoperative months(3 months)
- Adverse side effects:Hallucinations / Delirium.Sedation. Diplopia, Hyperglycemia Respiratory depression (Sat <90%)(4 hours post operative)
研究者
Dr Emili Leon
Principal Investigator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta