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雾化右美托咪定治疗椎管内麻醉下择期剖宫产产妇硬脊膜穿破后头痛的疗效:一项随机对照研究。

Effectiveness of nebulized dexmedetomidine for treatment of post-dural puncture headache in parturients undergoing elective cesarean section under spinal anesthesia: a randomized controlled study.

机构信息

Department of Anesthesia and Surgical Intensive Care, Faculty of Medicine, Zagazig University, Zagazig, Egypt.

出版信息

J Anesth. 2021 Aug;35(4):515-524. doi: 10.1007/s00540-021-02944-6. Epub 2021 May 16.

Abstract

PURPOSE

The need for effective treatment for post-dural puncture headache (PDPH) is a growing research entity. This study aimed to test the effectiveness of additional dexmedetomidine (DEX) to PDPH conservative management and evaluate its cerebral hemodynamic effects trans-cranial Doppler.

METHODS

This prospective randomized double-blind controlled trial was conducted on 43 post-partum females suffering from PDPH with visual analog score (VAS) ≥ 4 and Lybecker score ≥ 2. The study subjects were allocated into control group [n = 22] received nebulization of 4 mL 0.9% saline and DEX group [n = 21] received nebulization of 1 µg/kg DEX diluted in 4 mL 0.9% saline twice daily that was continued until achieving VAS score ≤ 3 and Lybecker score < 2 and/or for a maximum of 72 h. Both groups received routine conservative management. The primary outcome was the VAS and Lybecker scores and the secondary results were the DEX effects on cerebral vessels and the occurrence of any adverse effects.

RESULTS

VAS and Lybecker scores were significantly lower in DEX group. The middle cerebral artery mean flow velocity was significantly lower, and the pulsatility index was considerably higher after DEX nebulization compared to placebo. Two patients in the control group were indicated for epidural blood patch.

CONCLUSION

The addition of DEX nebulization (1 µg/kg twice daily) to the PDPH conservative care effectively relieved the symptoms and lowered pain scores which could be due to its analgesic and cerebral vasoconstrictive effects.

TRIAL REGISTRATION

This study was approved by the research ethical committee of Faculty of Medicine, Zagazig University with the reference number (ZU-IRB#: 6075/26-4-2020) and it was registered under clinicaltrials.gov (NCT04327726).

摘要

目的

对于硬膜穿刺后头痛(PDPH)的有效治疗需求是一个日益增长的研究实体。本研究旨在测试额外使用右美托咪定(DEX)对 PDPH 保守治疗的效果,并通过经颅多普勒评估其对脑血流动力学的影响。

方法

这是一项前瞻性随机双盲对照试验,纳入了 43 名患有 PDPH 的产后女性(视觉模拟评分(VAS)≥4 分且 Lybecker 评分≥2 分)。研究对象被随机分为对照组(n=22),接受 4 mL 0.9%生理盐水的雾化吸入;DEX 组(n=21)接受 1μg/kg DEX 稀释于 4 mL 0.9%生理盐水的雾化吸入,每日两次,持续至 VAS 评分≤3 分且 Lybecker 评分<2 分,或最长 72 小时。两组均接受常规保守治疗。主要结局为 VAS 和 Lybecker 评分,次要结局为 DEX 对脑血管的影响和任何不良反应的发生。

结果

DEX 组的 VAS 和 Lybecker 评分显著降低。与安慰剂相比,DEX 雾化后大脑中动脉平均血流速度显著降低,搏动指数显著升高。对照组有 2 例患者需要进行硬膜外血贴治疗。

结论

在 PDPH 保守治疗中加入 DEX 雾化吸入(每日两次 1μg/kg)可有效缓解症状并降低疼痛评分,这可能与其镇痛和血管收缩作用有关。

试验注册

本研究得到了 Zagazig 大学医学院研究伦理委员会的批准(参考编号:ZU-IRB#:6075/26-4-2020),并在 clinicaltrials.gov 上注册(NCT04327726)。

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