Regional Intravenous Analgesic Effect of Dexmedetomidine in Knee Surgeries Under Spinal Anesthesia: A Prospective, Randomized, Double-Blind Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 主要终点
- postoperative duration of analgesia
研究概览
简要总结
Dexmedetomidine is a highly selective α₂-adrenergic receptor agonist that exerts its effects by inhibiting the release of norepinephrine at presynaptic nerve terminals, leading to reduced sympathetic activity; This mechanism results in analgesia, sedation, and anxiolysis without significant respiratory depression
详细描述
In the context of intravenous regional anesthesia (IVRA), dexmedetomidine has been employed as an adjuvant to local anesthetics like lidocaine to improve block characteristics; Clinical studies have demonstrated that adding dexmedetomidine to lidocaine in IVRA accelerates the onset of sensory and motor blocks, extends the duration of postoperative analgesia, and reduces the incidence of tourniquet pain
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, Investigator)
盲法说明
An anesthetist, not involved in the study , was responsible for randomization list construction, in blocks, opening the sealed envelopes and so, the preparation of the study drug
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years
- •American Society of Anesthesiologists (ASA) Physical Status Classification System I or II
- •Scheduled for elective knee surgery under spinal anesthesia
- •Body mass index (BMI) 18-30 kg/m²
- •Able to provide informed consent
排除标准
- •Pregnant or lactating women
- •Hypersensitivity to dexmedetomidine
- •Chronic kidney diseases serum creatinine >1.5 mg\dl or Patient has known renal disease
- •Chronic opioid or sedative use
- •Any cardiac conduction abnormalities
- •Uncontrolled arterial hypertension
- •Neuropathy
- •Diabetes mellitus
- •Impaired perfusion of the operative limb (Edema, Peripheral vascular Disease e.g "Raynaud Phenomenon")
- •History or recent lower limb deep venous thrombosis (DVT) or Phlebitis
- •Infection or vascular access limitation in the operated lower limbs
- •Any contraindication of spinal anesthesia e.g "Coagulopathy"
- •Any contraindications for tourniquet e.g "sickle cell anemia"
研究组 & 干预措施
Dexmedetomidine
after spinal anesthesia; patient will receive 0.5 mcg/kg dexmedetomidine, diluted in a normal saline injected intravenously below the Pneumatic tourniquet after its inflation
干预措施: Dexmedetomidine (Drug)
control
after spinal anesthesia; patient will receive normal saline injected intravenously below the Pneumatic tourniquet after its inflation
干预措施: Normal Saline (Drug)
结局指标
主要结局
postoperative duration of analgesia
时间窗: within 24 hours after the surgery
the time measured from the study drug injection to the first request of analgesia by the patient
次要结局
- The time of sensory block regression in both lower limbs(Postoperatively every 15 min till full regression of the sensory block (score =0))
- The motor block regression time in both lower limbs(every 15 min till confirmation of full regression of the motor block (Modified Bromage Scale=0))
- total postoperative analgesic consumption(in the first 24-hour postoperative)
- Sedation levels(done Perioperatively at the following time points (Immediately before spinal anesthesia and immediately before tourniquet deflation. Then 5, 15, 30 min besides, 1, 2, 4, and 6 hours after tourniquet deflation))
- heart rate (HR),(preoperative, immediately after inject both spinal anesthesia and study drug, then every 5 minutes for the first 30 minutes and then every 15 minutes till end of the surgery. also, record after tourniquet deflation 5, 15, 30 min beside 1, 2, 4, 6 hours)
- systolic blood pressure (SBP)(preoperative, immediately after inject both spinal anesthesia and study drug, then every 5 minutes for the first 30 minutes and then every 15 minutes till end of the surgery. also, record after tourniquet deflation 5, 15, 30 min beside 1, 2, 4, 6 hours)
研究者
maha abou-zeid
Assistant Professor of Anesthesia and Surgical Intensive Care
Mansoura University