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剖宫产术中鞘内注射高压布比卡因联合或不联合鞘内注射右美托咪定的半数有效剂量(ED50)比较:一项采用上下序贯分配法的前瞻性、双盲、随机剂量反应试验。

Comparison of the ED50 of intrathecal hyperbaric ropivacaine co-administered with or without intrathecal dexmedetomidine for cesarean section: A prospective, double-blinded, randomized dose-response trial using up-down sequential allocation method.

作者信息

Tang Yuwen, Yang Meijuan, Fu Feng, Huang Xiaodong, Feng Ying, Chen Xinzhong

机构信息

Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Xueshi Road 1#, Hangzhou, Zhejiang 310006, China.

Department of Anesthesia, Hangzhou Women's Hospital, Kunpeng Road 369#, Hangzhou, Zhejiang 310008, China.

出版信息

J Clin Anesth. 2020 Jun;62:109725. doi: 10.1016/j.jclinane.2020.109725. Epub 2020 Feb 7.

Abstract

STUDY OBJECTIVE

Studies have showed that intrathecal dexmedetomidine as supplements to local anesthetics can improve the quality of the spinal anesthesia and reduce the local anesthetic requirement of spinal anesthesia for cesarean section. However, the magnitude of this effect has not been fully quantified. Therefore, we conducted the present study to investigate the ED of intrathecal hyperbaric ropivacaine with or without dexmedetomidine for cesarean section in healthy parturients. ED values obtained were compared to estimate the effect of intrathecal dexmedetomidine versus placebo on ropivacaine requirement.

DESIGN

Single-blinded, prospective, randomized study.

SETTING

Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine.

PATIENTS

Sixty healthy parturients under elective cesarean section with combined spinal-epidural anesthesia were randomized into Group C (intrathecal ropivacaine alone) and Group D (intrathecal ropivacaine + 5 μg dexmedetomidine).

INTERVENTIONS

The dose of intrathecal ropivacaine for the first parturient in both groups was 11 mg. An increment or decrement of 0.5 mg intrathecal ropivacaine was made for the subsequent parturient based on the effective or ineffective response of the previous parturient. Effective dose was defined as a bilateral T6 or above sensory block level was achieved within 15 min after induce of spinal anesthesia and no additional epidural anesthetics was required during surgery. The Dixon and Massay sequential method and Probit regression were applied to calculate the ED of intrathecal ropivacaine in both groups.

MEASUREMENTS

Characteristics of spinal anesthesia and side effects were recorded.

MAIN RESULTS

The ED of hyperbaric ropivacaine calculated by Dixon and Massay formula was 11.4 mg (95% CI, 11.1-11.7 mg) in Group C, and 9.4 mg (95% CI, 9.0-9.7 mg) in Group D (P < 0.05). While using the Probit regression, the ED of intrathecal hyperbaric ropivacaine was 11.1 mg (95% CI, 10.7-11.6 mg) in Group C, and 9.1 mg (95% CI, 8.6-9.5 mg) in Group D. Shivering was less observed in Group D than in Group C (P < 0.05). There was no significant difference in the onset time of sensory block or motor block, the incidence of hypotension, bradycardia, nausea and vomiting, sedation and pruritus between the two groups.

CONCLUSION

Under the conditions of the present study, intrathecal dexmedetomidine (5 μg) reduced the ED of intrathecal hyperbaric ropivacaine by approximately 18% for cesarean section in healthy parturients under combined spinal-epidural anesthesia.

摘要

研究目的

研究表明,鞘内注射右美托咪定作为局部麻醉药的补充剂可提高腰麻质量,并降低剖宫产腰麻时局部麻醉药的需求量。然而,这种效果的程度尚未完全量化。因此,我们进行了本研究,以调查在健康产妇剖宫产中,鞘内注射重比重罗哌卡因加或不加右美托咪定的半数有效剂量(ED)。比较获得的ED值,以评估鞘内注射右美托咪定与安慰剂对罗哌卡因需求量的影响。

设计

单盲、前瞻性、随机研究。

地点

浙江大学医学院附属妇产科医院麻醉科。

患者

60例行腰麻-硬膜外联合麻醉的择期剖宫产健康产妇被随机分为C组(单纯鞘内注射罗哌卡因)和D组(鞘内注射罗哌卡因 + 5μg右美托咪定)。

干预措施

两组中第一位产妇鞘内注射罗哌卡因的剂量为11mg。根据前一位产妇的有效或无效反应,为后续产妇鞘内注射罗哌卡因增加或减少0.5mg。有效剂量定义为腰麻诱导后15分钟内达到双侧T6及以上感觉阻滞平面,且手术期间无需额外硬膜外麻醉药。应用Dixon和Massay序贯法及概率回归计算两组鞘内注射罗哌卡因的ED。

测量指标

记录腰麻特征及副作用。

主要结果

根据Dixon和Massay公式计算,C组重比重罗哌卡因的ED为11.4mg(95%CI,11.1 - 11.7mg),D组为9.4mg(95%CI,9.0 - 9.7mg)(P < 0.05)。使用概率回归时,C组鞘内重比重罗哌卡因的ED为11.1mg(95%CI,10.7 - 11.6mg),D组为9.1mg(95%CI,8.6 - 9.5mg)。D组寒战的发生率低于C组(P < 0.05)。两组在感觉阻滞或运动阻滞的起效时间、低血压、心动过缓、恶心呕吐、镇静和瘙痒的发生率方面无显著差异。

结论

在本研究条件下,鞘内注射右美托咪定(5μg)可使腰麻-硬膜外联合麻醉下健康产妇剖宫产时鞘内重比重罗哌卡因的ED降低约18%。

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