Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.
Feng Xian People's Hospital of Jiangsu Province, Xuzhou, Jiangsu, China.
BMC Anesthesiol. 2020 Aug 3;20(1):190. doi: 10.1186/s12871-020-01109-4.
The efficacy and safety of spinal anesthesia by intrathecal dexmedetomidine (DEX) for parturients undergoing cesarean section are still lack of evidence. This aim of our study was to evaluate the efficacy and safety of intrathecal DEX for parturients undergoing cesarean section to provide more data evidence for intrathecal applications.
Three hundred parturients undergoing cesarean section under spinal anesthesia were randomly assigned into three groups: group B: 9.0 mg (1.2 ml) of 0.75% bupivacaine with saline (1 ml); group FB: 9.0 mg (1.2 ml) of 0.75% bupivacaine with 20 μg of fentanyl (1 ml); group DB: 9.0 mg (1.2 ml) of 0.75% bupivacaine with 5 μg of DEX (1 ml). Intraoperative block characteristics, parturients' postoperative quality of recovery, maternal and neonatal outcomes and the plasma concentration of DEX were measured. All parturients were followed up for 30 days to determine whether nerve injury occurred.
Compared with group B, the duration of sensory block in group FB and group DB were significantly prolonged (108.4 min [95% Confidence Interval (CI) = 104.6-112.3] in group B, and 122.0 min [95% CI = 116.8-127.3] in group FB, 148.2 min [95% CI = 145.3-151.1] in group DB). The overall score of quality recovery in group DB (71.6 [95% CI = 71.0-72.2]) was significantly higher than that in group FB (61.5 [95% CI = 60.8-62.2]) and group B (61.7 [95% CI = 61.0-62.4]). There was no statistically significant difference among the three groups for PH, PaO, and PaCO of newborn. The plasma concentration of DEX in umbilical artery and umbilical vein was low and cannot be detected. The 30-days follow-up of parturients did not show any new onset of back, buttock or leg pain or paresthesia.
DEX is a potential local anesthetic adjuvant that the intrathecal combination of 5 μg DEX can safely exhibit a facilitatory block effect and improve parturients' recovery quality.
Chinese Clinical Trial Registry (Registration number # ChiCTR1900022019 ; Date of Registration on March 20th, 2019).
鞘内应用右美托咪定（DEX）对行剖宫产术的产妇进行椎管内麻醉的疗效和安全性仍缺乏证据。本研究旨在评估鞘内应用 DEX 对行剖宫产术产妇的疗效和安全性，为鞘内应用提供更多数据证据。
300 例行椎管内麻醉剖宫产术的产妇被随机分为三组：B 组：9.0mg（1.2ml）0.75%布比卡因加生理盐水（1ml）；FB 组：9.0mg（1.2ml）0.75%布比卡因加 20μg 芬太尼（1ml）；DB 组：9.0mg（1.2ml）0.75%布比卡因加 5μg DEX（1ml）。记录术中阻滞特点、产妇术后恢复质量、母婴结局和 DEX 血浆浓度。所有产妇均随访 30 天，以确定是否发生神经损伤。
与 B 组相比，FB 组和 DB 组的感觉阻滞持续时间明显延长（B 组为 108.4min[95%可信区间（CI）=104.6-112.3]，FB 组为 122.0min[95%CI=116.8-127.3]，DB 组为 148.2min[95%CI=145.3-151.1]）。DB 组的总体恢复质量评分（71.6[95%CI=71.0-72.2]）明显高于 FB 组（61.5[95%CI=60.8-62.2]）和 B 组（61.7[95%CI=61.0-62.4]）。三组新生儿的 pH、PaO 和 PaCO 无统计学差异。脐动脉和脐静脉中 DEX 的血浆浓度较低，无法检测到。产妇 30 天随访未发现新发腰、臀部或腿部疼痛或感觉异常。
DEX 是一种潜在的局部麻醉辅助药物，鞘内应用 5μg DEX 可安全地产生促进阻滞作用，提高产妇的恢复质量。
中国临床试验注册中心（注册号：ChiCTR1900022019；注册日期：2019 年 3 月 20 日）。
