The Analgesic Effect of Intrathecal Dexmedetomidine With Bupivacaine, in Patients Undergoing Knee Orthopedic Surgery: A Randomized Double-Blinded Dose-Finding Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Time to request rescue analgesia
研究概览
简要总结
This study aims to compare the duration of analgesia (as the primary outcome) and adverse effects (as the secondary outcome) after intrathecal administration of dexmedetomidine with hyperbaric bupivacaine to patients undergoing knee orthopedic surgery.
详细描述
Intrathecal adjuncts are commonly added to local anesthetic agents, to improve the duration of nerve blocks and postoperative pain relief without increasing the dosage of local anesthetic.
Studies have shown that dexmedetomidine (DEX) has a greater potential for enhancing analgesic effects due to its higher specificity for alpha2 adrenoceptors. DEX is commonly used for sedation and as an adjunct to reduce the amount of anesthesia and opioids required during general and regional anesthesia in both adults and children.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 65 years.
- •American Society of Anesthesiologists (ASA) physical status I-II.
- •Male patients scheduled for knee orthopedic surgery.
排除标准
- •Patients with psychiatric disorders.
- •History of drug addiction.
- •Contraindication for regional anesthesia.
- •History of hypersensitivity to the study drugs.
- •Previous administration of opioids and/or other central nervous system depressants during current hospital admission.
研究组 & 干预措施
Group I
Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 4 μg.
干预措施: Dexmedetomidine 4 μg (Drug)
Group II
Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 8 μg.
干预措施: Dexmedetomidine 8 μg (Drug)
Group III
Patients will receive intrathecal hyperbaric bupivacaine 15 mg, supplemented with dexmedetomidine 12 μg.
干预措施: Dexmedetomidine 12 μg (Drug)
结局指标
主要结局
Time to request rescue analgesia
时间窗: 24 hours postoperatively
Time to request rescue analgesia will be recorded from the end of surgery to the first dose of morphine administrated
次要结局
- Heart rate(In the recovery room (Up to 2 hours))
- Mean arterial blood pressure(In the recovery room (Up to 2 hours))
- Respiratory rate(In the recovery room (Up to 2 hours))
- Oxygen saturation(In the recovery room (Up to 2 hours))
研究者
Ahmed Abdou Ali Ismail
Assistant Lecturer of Anaesthesia, Surgical ICU, and Pain, Cairo University, Cairo, Egypt.
Cairo University