Efficacy of Intrathecal Clonidine Versus Neostigmine as Adjuvants to Bupivacaine on Postoperative Maternal and Fetal Outcomes After Elective Cesarean Section: A Randomized Double Blind Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 111
- 主要终点
- postoperative analgesic efficacy of intrathecal clonidine and neostigmine by use of numerical rating scale (NRS) pain score.
研究概览
简要总结
The delivery of the infant into the arms of a conscious and pain free mother is one of the most exciting and rewarding moments in medicine. Neuraxial anesthesia is now the preferred technique for lower segment cesarean sections (LSCS). Although epidural, spinal, continuous spinal, and combined spinal-epidural techniques have all been advocated, most cesarean sections are performed under single-shot spinal anesthesia.
Even when a long acting local anesthetic like bupivacaine is used, the duration of spinal anesthesia (SA) is short and higher doses of analgesics are required in the postoperative period. Therefore, achieving a subarachnoid block that provides high quality postoperative analgesia of consistently prolonged duration is an attractive goal.
详细描述
Opioids such as morphine, fentanyl, and sufentanil have been administered intrathecally as adjuvants to increase the duration of postoperative analgesia. Although they ensure superior quality of analgesia, they are associated with many side effects such as pruritus, nausea, vomiting, urinary retention, and especially late and unpredictable respiratory depression.
This has directed the research toward the use of newer and better local anesthetic additives for SA such as neostigmine, ketamine, midazolam, and clonidine.
Neostigmine is an anticholinesterase agent which increases the acetylcholine (Ach) concentration at the cholinergic synapse by blocking the activity of true and pseudocholinesterase enzymes. In postoperative period descending noradrenergic or cholinergic antinociceptive spinal system is activated by ongoing pain causing an increase in the release of Ach, which in the presence of neostigmine results in augmented analgesia. It has no untoward side effects such as respiratory depression, pruritus, and drowsiness as experienced with intrathecal narcotics.Clonidine is an α2-receptor agonist which has gained popularity in recent times as an adjuvant in spinal anesthesia. Analgesic effect of clonidine mediated by α2-adrenoceptors situated in the dorsal horn of spinal cord. The antinociceptive properties of clonidine indicate that it might be useful as an alternative to intrathecal opioids for postoperative analgesia, thus also avoiding the adverse effect of opioids.
Neostigmine was used in different dose ranges from 5 µg to 750 µg intrathecally but a low dose of 5 µg is sufficient to cause early onset of sensory and motor block.
On the other hand, clonidine was used in different doses from 15 µg to 450 µg, and many previous studies concluded that minimum 30 µg dose of clonidine provide a significant increase in the duration of sensory block, motor block, and spinal analgesia without increasing the incidence of side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: ranges from 20 - 35 years old.
- •ASA physical status II.
- •Singleton fetus at term.
- •Parturient scheduled for elective lower segment cesarian section under spinal anethesia
排除标准
- •Patient refusal.
- •Contraindications to spinal blockade, such cardiorespiratory problems, coagulopathy, neurological disease, psychological troubles, and allergy to the used drugs.
- •Morbid obesity.
- •Failure of spinal blockade.
- •Emergency CS.
- •Complicated pregnancy.
- •Intrauterine fetal compromise.
研究组 & 干预措施
Group B
control group : will receive 2 ml (10 mg) of intrathecal hyperbaric Bupivacaine (0.5%) and another syringe containing 1 ml of Dextrose 5%.
干预措施: Clonidine (Drug)
Group BC
will receive 2 ml (10 mg) of intrathecal hyperbaric Bupivacaine (0.5%) and another syringe containing Clonidine (30 µg) diluted in Dextrose 5% to a total volume of 1 ml.
干预措施: Clonidine (Drug)
Group BN
will receive 2 ml (10 mg) of intrathecal hyperbaric Bupivacaine (0.5%) and another syringe containing Neostigmine (10 µg) diluted in Dextrose 5% to a total volume of 1 ml.
干预措施: Clonidine (Drug)
结局指标
主要结局
postoperative analgesic efficacy of intrathecal clonidine and neostigmine by use of numerical rating scale (NRS) pain score.
时间窗: 2 hours after time of sensory block
using numerical rating scale (NRS) pain score that ranges from 0 indicating no pain up to 10 indicating the worst pain
次要结局
未报告次要终点
研究者
Yasser Mamdouh Hassan Badawy
Assistant lecturer of anesthesia and intensive care
Assiut University