Comparison Between Intra-articular Dexmedetomidine and Neostigmine as Adjuvant Analgesics After Knee Arthroscopy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- postoperative pain
研究概览
简要总结
Knee arthroscopy is a minimally invasive day case procedure which may be done for diagnosis, meniscectomy or debridement. Arthroscopic surgery is associated with a variable degree of postoperative pain, which is caused by an irritation of free nerve endings of the synovial tissue, anterior fat pad, and joint capsule due to surgical excision and resection
详细描述
Many studies were done using different intra-articular agents as local anesthetics, opioids, ketamine and alfa2- adrenergic agonists for prevention and treatment of pain after knee surgeries.
Dexmedetomidine is a potent and highly selective alfa2-adrenoreceptor agonist. It has sedative-hypnotic, anxiolytic, analgesic, anesthetic and sympatholytic effects. Intra-articular dexmedetomidine was used in several studies to enhance postoperative analgesia after knee arthroscopy with an increased time to first analgesic request and a decreased need for postoperative analgesia Neostigmine is an anticholinesterase and also has antinociceptive effects when administered intrathecally or peripherally.
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, Care Provider)
盲法说明
, Patients were randomly allocated (using random table assignment) into two groups to receive one of the following intra-articular solutions (prepared by an individual not involved in the study) which were injected into the knee joint through the cannular sheath after withdrawal of camera, by the orthopaedic surgeon (who was also unaware of the nature of the study drugs) before the arthroscope removed.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged above 18 years
- •scheduled for elective arthroscopic knee surgery under intrathecal anaesthesia
排除标准
- •Absolute or relative contraindications for intrathecal anaesthesia,
- •Allergy for the studied drugs.
- •Patients having history of cardiovascular, cerebrovascular, and respiratory diseases,
- •Patients receiving chronic pain treatment or hypertension treated with alfa methyldopa, clonidine or beta adrenergic blockers were excluded from the study.
研究组 & 干预措施
dexmedetomidine (D group)
intraarticular administration of dexmedetomidine at the end of surgery
干预措施: dexamedetomidine (Drug)
neostigmine (N group)
intraarticular administration of neostigmine at the end of surgery.
干预措施: neostigmine (Drug)
结局指标
主要结局
postoperative pain
时间窗: 36 hours after the end of the surgery.
visual analogue pain scale
次要结局
- nausea,vomiting(36 hours after the end of the surgery.)
- sedation(36 hours after the end of the surgery.)
研究者
Ghada Mohammed AboelFadl
Principal Investigator
Assiut University