Single-dose intravenous remimazolam reduces risk of post-cesarean shivering and promotes postoperative recovery: a randomized double-blind controlled trial

Zhang Hui; Xu Fanning; Li Dan; Li Fen; Chang Liya; Wang Dandan

doi:10.16016/j.2097-0927.202606045

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Single-dose intravenous remimazolam reduces risk of post-cesarean shivering and promotes postoperative recovery: a randomized double-blind controlled trial

Clinical Medicine | 更新时间：2026-10-01

- Single-dose intravenous remimazolam reduces risk of post-cesarean shivering and promotes postoperative recovery: a randomized double-blind controlled trial
- Journal of Army Medical University Vol. 48, Issue 18, Pages: 2656-2664(2026)
- 作者机构：
  
  西安交通大学第一附属医院榆林医院麻醉科，陕西榆林
- 作者简介：
  
  Wang Dandan，E-mail：wangdandan2025@163.com
- 基金信息：
  
  the Natural Science Basic Research Program of Shaanxi Province(2025JC-YBQN-300)
- DOI：10.16016/j.2097-0927.202606045
  CLC： R441.3;R719.8;R971.2
- Received：10 June 2026，
  
  Revised：2026-08-03，
  
  Accepted：05 August 2026，
  
  Published：30 September 2026
- 稿件说明：
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张慧，徐反宁，李丹，等.单次静脉注射小剂量瑞马唑仑降低剖宫产术后寒战风险并促进术后恢复：一项随机双盲对照试验［J］.陆军军医大学学报，2026，48（18）：2656-2664.DOI：10.16016/j.2097-0927.202606045.

Zhang H，Xu F N，Li D，et al.Single-dose intravenous remimazolam reduces risk of post-cesarean shivering and promotes postoperative recovery： a randomized double-blind controlled trial［J］.J Army Med Univ，2026，48（18）：2656-2664.DOI：10.16016/j.2097-0927.202606045.
张慧，徐反宁，李丹，等.单次静脉注射小剂量瑞马唑仑降低剖宫产术后寒战风险并促进术后恢复：一项随机双盲对照试验［J］.陆军军医大学学报，2026，48（18）：2656-2664.DOI：10.16016/j.2097-0927.202606045. DOI：

Zhang H，Xu F N，Li D，et al.Single-dose intravenous remimazolam reduces risk of post-cesarean shivering and promotes postoperative recovery： a randomized double-blind controlled trial［J］.J Army Med Univ，2026，48（18）：2656-2664.DOI：10.16016/j.2097-0927.202606045. DOI：

摘要

目的

腰硬联合麻醉下剖宫产术后寒战发生率高，会导致产妇不适、增加氧耗、干扰生命体征监测，甚至引发不良心血管及呼吸事件。瑞马唑仑（新型超短效苯二氮䓬类药物）在全身麻醉中可降低术后寒战发生率，本研究旨在评估瑞马唑仑对腰硬联合麻醉下剖宫产术后寒战的预防效果及对产妇术后恢复质量的影响。

方法

采用前瞻性随机双盲安慰剂对照研究设计方案，选取2025年6—12月在西安交通大学第一附属医院榆林医院行择期腰硬联合麻醉下剖宫产术的单胎足月产妇140例（年龄24~40岁，ASA Ⅱ级，BMI≤35 kg/m²），随机分配至瑞马唑仑（Remimazolam，胎儿娩出夹闭脐带后静脉注射瑞马唑仑0.2 mg/kg）组和对照（Control，给予等容量生理盐水）组（

=70）。采用床旁寒战评估量表BSAS评估2组椎管内麻醉后90 min内中重度寒战发生率，术后1、2 d恢复质量（包括情绪状态、心理支持、身体舒适度、身体独立性和疼痛5个维度量表）、给药后90 min内警觉/镇静评估（OAA/S）评分及术中不良反应（低血压、心动过缓、恶心、呕吐、头晕）等指标。

结果

2组产妇年龄、体质量、孕周、初产妇比率、麻醉阻滞平面、术中失血量及手术时长等基线资料差异均无统计学意义（

0.05）。①主要结局事件：Remimazolam组中重度寒战总发生率为27.1%（19/70），显著低于Control组的55.7%（39/70，

0.001）；与Control组相比，Remimazolam组发生中重度寒战的风险降低62%（

=0.38，95%

：0.22~0.67，

=0.000 4）；0~30 min时段Remimazolam组中重度寒战发生率（10.0%）显著低于Control组（25.7%，

=0.027）。

②次要结局事件：术后1 d QoR-15总分Remimazolam组为126（124，128）分，显著高于Control组的116（115，118）分（

0.001）；术后2 d Remimazolam组为141（140，143）分，显著高于Control组的133（130，135）分（

0.001）。其中Remimazolam组在情绪状态、心理支持、身体舒适度3个维度评分均高于Control组（均

0.001），2组在身体独立性和疼痛维度评分差异无统计学意义（

0.05）。Remimazolam组给药后15 min OAA/S评分为5（4，5）分，低于Control组的5（5，5）分（

=0.004），30 min后恢复至对照组水平（

0.05）。2组心动过缓、低血压、恶心、呕吐及头晕等不良反应发生率差异均无统计学意义（均

0.05）。

结论

腰硬联合麻醉下剖宫产术中胎儿娩出后单次静脉注射0.2 mg/kg瑞马唑仑，可使术后中重度寒战风险降低62%，同时可显著改善产妇术后1、2 d的恢复质量（尤其在情绪状态、心理支持和身体舒适度维度），且仅产生轻度、可逆的术中镇静作用，不增加不良反应风险。

Abstract

Objective

Post-cesarean shivering under combined spinal-epidural anesthesia (CSEA) is highly prevalent

which can cause to maternal discomfort

increase oxygen consumption

interfere with vital sign monitoring

and potentially lead to adverse cardiovascular and respiratory events. Remimazolam

a novel ultrashort-acting benzodiazepine

has been shown to reduce postoperative shivering in general anesthesia. This study aims to evaluate the prophylactic effect of remimazolam on post-cesarean shivering under CSEA and its impact on maternal recovery quality.

Methods

A prospective randomized double-blind placebo-controlled trial was conducted on 140 singleton full-term parturients (aged 24-40 years

ASA physical status II

BMI ≤35 kg/m²) undergoing elective cesarean section under CSEA in our hospital from June to December 2025. They were randomly assigned to a remimazolam group (Group Remimazolam

receiving a single intravenous injection of remimazolam 0.2 mg/kg immediately after delivery and umbilical cord clamping

=70) and a control group (Group Control

=70

receiving an equal volume of normal saline). The incidence of moderate-to-severe shivering within 90 min after neuraxial anesthesia

[assessed using the Bedside Shivering Assessment Scale (BSAS)

]

. quality of recovery on postoperative days 1 and 2 [measured by the 15-item Quality of Recovery (QoR-15) scale

covering 5 dimensions: emotional state

psychological support

physical comfort

physical independence

and pain

]

Observer's Assessment of Alertness/Sedation (OAA/S) scores within 90 min after drug administration

and intraoperative adverse reactions (hypotension

bradycardia

nausea. vomiting and dizziness) were compared between the 2 groups.

Results

There were no statistically significant differences in baseline characteristics between the 2 groups

including age

body weight

gestational age

primipara ratio

anesthetic block level

intraoperative blood loss

or operative duration (all

0.05). ① For the primary outcome

the overall incidence of moderate-to-severe shivering in Group Remimazolam was 27.1% (19/70)

significantly lower than that in Group Control [55.7% (39/70)

0.001

]

. Remimazolam reduced the risk of moderate-to-severe shivering by 62% compared with the risk in the Group Control (

=0.38

95%

: 0.22 to 0.67

=0.000 4). During the 0-30 min period

the incidence of moderate-to-severe shivering was significantly lower in Group Remimazolam than in Group Control (10.0%

25.7%

=0.027). ②For secondary outcomes

the QoR-15 total score on postoperative day 1 was 126 (124

128) in Group Remimazolam

which was significantly higher than that in the Control group [116 (115

118)

0.001

]

; on postoperative day 2

the Remimazolam group scored 141 (140

143)

which was significantly higher than that in the Control group [133 (130

135)

0.001

]

. Group Remimazolam showed significantly higher scores in the dimensions of emotional state

psychological support

and physical comfort (all

0.001)

whereas there were no sta

tistically significant differences between the 2 groups in the dimensions of physical independence or pain (

0.05). The OAA/S score at 15 min after drug administration in the Remimazolam group was 5(4

which was lower than that in the Control group [5 (5

=0.004

]

and returned to the level of the control group after 30 min (

0.05). No significant differences were observed in the incidence of bradycardia

hypotension

nausea

vomiting or dizzines between the 2 groups (all

0.05).

Conclusion

A single intravenous dose of 0.2 mg/kg remimazolam administered immediately after delivery during cesarean section under CSEA can significantly reduce the risk of moderate-to-severe post-cesarean shivering by 62%

also improve the quality of maternal recovery on postoperative days 1 and 2 (particularly in the dimensions of emotional state

psychological support

and physical comfort). The regimen produces only mild

reversible intraoperative sedation without increasing the risk of adverse reactions.

关键词

Keywords

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