Intravenous Versus Perineural Dexmedetomidine as Adjuvant in Adductor Canal Block for Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- incidence of post-spinal anesthesia shivering
研究概览
简要总结
Shivering increases the cardiac and systemic energy expenditure, oxygen consumption and carbon dioxide production. Definitive prevention and treatment of shivering is necessary to decrease the related complications and increase post-anesthetic comfort.
详细描述
Dexmedetomidine a highly selective α2 adrenergic agonist used effectively as a safe analgesic via different routes and mechanisms, including intravenous (i.v.), neuraxial and perineural routes. Dexmedetomidine has been used for prevent shivering but, the results of its efficacy is still controversy.
No studies to date have investigated the best administration route of dexmedetomidine to dominantly prevent the occurrence of shivering after spinal anesthesia or associated with the least grade.
This prospective, randomized, double blinded study was designed to investigate the best administrative route of dexmedetomidine firstly, as a preventive of neuraxial shivering and secondly as adjunctive analgesic.
The incidence of post-spinal anesthesia shivering was the primary outcome. Perioperative hemodynamics, postoperative pain scores during rest and at 45-degree flexion of the knee, the analgesic duration, the first postoperative day analgesic consumption, the sedation score and early ambulation ability were the secondary outcomes.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The study anesthetic drugs both for adductor-canal-blockade and for intravenous infusion were prepared according to the group by an anesthetist who was not involved in its injection or the perioperative assessment
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients
- •both genders
- •American Society of Anesthesiologists physical status I and II
- •scheduled for unilateral primary TKA under spinal anesthesia
排除标准
- •chronic opioid use
- •known allergy to the used drugs
- •any contraindications to regional anesthesia like; patient refusal, coagulopathy, neuropathy or infection at the injection site
研究组 & 干预措施
intravenous dexmedetomidine
20 mL 0.25% levobupivacaine plus 1 mL normal saline will be administrated for adductor-canal-blockade while for intravenous solution; 0.5µg.kg-1 dexmedetomidine diluted in 20 mL normal saline will be prepared
干预措施: intravenous dexmedetomidine (Drug)
adductor-canal-blockade dexmedetomidine
20 mL 0.25% levobupivacaine containing 1 mL of 0.5 mcg.kg-1 dexmedetomidine will be used for adductor-canal-blockade whereas, 20 mL 0.9% saline will be prepared for intravenous infusion
干预措施: adductor canal block dexmedetomidine (Drug)
结局指标
主要结局
incidence of post-spinal anesthesia shivering
时间窗: up to 24 hours
5-point scale (0= no shivering, 1 =piloerection or peripheral vasoconstriction but no visible shivering; 2 =muscular activity in only one muscle group; 3 =muscular activity in more than one muscle group but not generalized and 4 = shivering involving the whole body)
次要结局
- non-invasive arterial blood pressure(every 15 minutes after spinal anesthesia till the end of the surgery then at 0.5, 1, 3, 6, 12 hours postoperative)
- total cumulative doses of rescue analgesic(after the first postoperative 24 hours)
- Modified Ramsay sedation scale(after 0.5 hour from adductor-canal-blockade then, 2, 4, 6, 8, 10, 12 and 24 hours postoperatively)
- Heart rate(every 15 minutes after spinal anesthesia till the end of the surgery then at 0.5, 1, 3, 6, 12 hours postoperative)
- The analgesic duration(during the first postoperative 24 hours)
- postoperative pain(preoperative, 2, 4, 6, 8, 10, 12 and 24 hours postoperatively)
研究者
maha abou-zeid
lecturer
Mansoura University