Effects of Intrathecal Dexmedetomidine on the Perioperative Clinical Profile of Bupivacaine-induced Spinal Anesthesia for Cesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- The time to two sensory block segment regression.
研究概览
简要总结
A Randomized, Controlled, Double blind study aiming to evaluate the analgesic potentials and side effect profile of different dose levels of Dexmedetomidine added to subarachnoid bupivacaine in full-term pregnant women undergoing elective cesarean section using spinal anesthesia. The investigators ultimate goal is to find out the least effective dose which will be associated with minimal or no side effects. The primary outcome will be the time to two sensory block segment regression.
详细描述
Alpha 2-agonists are non-opioid adjuvants with a significant role in extending the analgesic duration of subarachnoid block. When clonidine or Dexmedetomidine was added to intrathecal local anesthetics, the regression of sensory and motor blocks increased dose-dependently. Further, a recent meta-analysis including seven randomized controlled studies reported an increase in the duration of analgesia and reduced morphine requirement after the concomitant subarachnoid administration of clonidine.
Animal studies demonstrated that Dexmedetomidine added to bupivacaine significantly enhanced the duration of sensory and motor blockade of sciatic nerve block. Histo-pathological examination proved that all of the nerves analyzed had normal axons and myelin at 24 h and 14 days after the peri-neural administration of Dexmedetomidine. Several clinical studies confirmed the analgesic potentials and safe neurological outcome of neuraxially administered Dexmedetomidine in the non-obstetric settings while intrathecal clonidine proved to be a useful analgesic adjunct for spinal anesthesia in patients undergoing cesarean section. But to the best of the investigator knowledge the effects of intrathecal Dexmedetomidine on the perioperative clinical profile of bupivacaine-induced spinal anesthesia were not studied before in the obstetric patient population.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Full-term pregnant women.
- •Elective cesarean section using spinal anesthesia.
- •Singleton gestation.
- •American Society of Anesthesiologists (ASA) physical status classes I and II.
排除标准
- •Preterm pregnancy (<37 wks gestation).
- •Multiple gestation.
- •Cardiovascular disease (e.g., preeclampsia, hypertension) and the use of antihypertensive medication.
- •Conditions that preclude spinal anesthesia.
- •Failed spinal block and conversion to general anesthesia.
- •A history of established chronic pain.
- •Drug addiction.
- •A psychiatric disorder.
- •Inability to communicate effectively.
- •Asthma and allergy to non-steroidal anti-inflammatory drugs.
研究组 & 干预措施
DEX-5
Dexmedetomidine & Bupivacaine. Patients will receive intrathecal 12.5 mg isobaric bupivacaine and 5 μg Dexmedetomidine using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds.
干预措施: Dexmedetomidine & Bupivacaine. (Drug)
DEX-10
Dexmedetomidine & Bupivacaine. Patients will receive intrathecal 12.5 mg isobaric bupivacaine and 10 μg Dexmedetomidine using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds.
干预措施: Dexmedetomidine & Bupivacaine. (Drug)
DEX-15
Dexmedetomidine & Bupivacaine. Patients will receive intrathecal 12.5 mg isobaric bupivacaine and 15 μg Dexmedetomidine using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds.
干预措施: Dexmedetomidine & Bupivacaine. (Drug)
Control
Bupivacaine Only. Patients will receive intrathecal 12.5 mg isobaric bupivacaine only using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds.
干预措施: Bupivacaine Only. (Drug)
结局指标
主要结局
The time to two sensory block segment regression.
时间窗: 70 min
Define the start of regression of the level of sensory block
次要结局
- Intraoperative analgesic supplementation(70 min)
- Time from intrathecal injection to peak sensory block level.(10 min)
- The peak sensory level of the block.(10 min)
- Time to S1 level sensory regression.(70 min)
- Degree of motor block.(24 h)
- The total dose of ephedrine/atropine required to maintain hemodynamic stability.(24 h)
- The amount of lactated Ringer's solution required intraoperatively to maintain normal Blood pressure range(24 h)
- Oxygen saturation (the need for O2 supplementation)(24 h)
- Time to first postoperative rescue analgesic request(24 h)
- Postoperative pain scores for 24 hours(24 h)
- Frequency of administration of postoperative analgesics(24 h)
- Intraoperative hemodynamic variables.(24 h)
- Intraoperative sedation scores(24 h)
- Incidence of side effects (nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation)(24 h)
- New born Apgar Score(5 min)
- Duration of motor block.(24 h)
- Early postoperative hemodynamic variables.(24 h)
- Total dose of postoperative analgesics(24 h)
- Postoperative sedation scores(24 h)
研究者
Professor Mohamed Abdulatif Mohamed
Abdulatif M.
Cairo University