Dexmedetomidine Versus Nalbuphine as an Adjuvant to Intrathecal Bupivacaine in Lower Limb Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The post-operative analgesic duration
研究概览
简要总结
Spinal anesthesia is the most consistent block for lower abdomen and lower limb surgical procedures. Over years many drugs have been used as an additive to spinal anesthesia in order to prolong the duration of action and to provide adequate postoperative analgesia.
Dexmedetomidine, a highly selective α2 agonist is rapidly emerging as the choice of additive to spinal anesthesia in view of its property to provide analgesia however, it may be associated with bradycardia which may affect the hemodynamic stability.
Nalbuphine is an opioid with agonist actions in the kappa receptor and antagonist actions in the mu receptor, it produces analgesia and sedation and lesser side effects through antagonism at the mu receptor but, it could be associated with some side effects as: dizziness, bradycardia, nausea, vomiting, and pruritus and may be associated with respiratory depression.
详细描述
This prospective, double blinded, randomized, controlled study will be held to compare Nalbuphine versus Dexmedetomidine as adjuvants to intrathecal Bupivacaine in spinal anesthesia in patients undergoing lower limb orthopedic surgeries
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
Intrathecal injectate will be prepared according to the group by an anesthesiologist who is not involved in data collection
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 60 years.
- •Both genders.
- •Patients scheduled for lower limb orthopedic surgeries under spinal anesthesia.
- •American society of anesthesiologists (ASA) class I or II.
排除标准
- •Patient refusal.
- •Age <20 or >60 years.
- •Contraindications to spinal anesthesia (e.g. bleeding diathesis, spinal cord deformities, infection at injection site).
- •History of allergy to any of the study medications.
- •Cases with severe cardiac, renal, or hepatic disease.
- •American society of anesthesiologists (ASA) class III, IV.
- •Patient on regular analgesics or opioid abuse.
- •Patient with peripheral neuropathy.
研究组 & 干预措施
Bupivacaine-Dexmedetomidine group (BD gp)
Patients will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus 10 µg Dexmedetomidine in 0.5 mL normal saline
干预措施: Dexmedetomidine (Drug)
Bupivacaine-Nalbuphine group (BN gp)
Patients will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus 1 mg Nalbuphine in 0.5 mL normal saline
干预措施: Nalbuphine (Drug)
结局指标
主要结局
The post-operative analgesic duration
时间窗: during the first 24 postoperative hours
次要结局
- Onset of motor block(After intrathecal injection up to 15 minutes)
- Heart rate (HR)(Every 5 minutes after spinal injection for the first 30 minutes, and then every 15 minutes till the end of surgery)
- Onset of sensory block(After intrathecal injection up to 15 minutes)
- Mean arterial pressure (MAP)(Every 5 minutes after spinal injection for the first 30 minutes, and then every 15 minutes till the end of surgery)
- Hypotension will be considered if there was 25% decrease below the baseline for Mean arterial pressure (MAP)(every 5 minutes after spinal injection for the first 30 minutes, then every 15 minutes till the end of surgery and every 30 minutes for the first 6 hours postoperatively)
- Bradycardia will be considered if the heart rate is less than 50 beats/min(every 5 minutes after spinal injection for the first 30 minutes, then every 15 minutes till the end of surgery and every 30 minutes for the first 6 hours postoperatively)
- postoperative pain(at 0, 2, 4, 6, 8,12,18 and 24 hours postoperatively)
- side effects as Vomiting, Nausea, pruritus, shivering(Intraoperatively and for the first 24 hours postoperatively)
- sedation(at 0, 2, 4, 6, 8,12,18 and 24 hours postoperatively)
研究者
maha abou-zeid
Assistant Professor of Anesthesia and Surgical Intensive Care
Mansoura University