Yin Hai-Ying, Wan Li, Huang Han
Departmentof Anesthesiology, West China Second University Hospital, Sichuan University, Chengdu 610041, China.
Key Laboratory of Birth Defects and Related Diseases of Women and Children of the Ministry of Education, Sichuan University, Chengdu 610041, China.
Sichuan Da Xue Xue Bao Yi Xue Ban. 2022 Sep;53(5):880-889. doi: 10.12182/20220960204.
To determine and compare the 90% effective dose (ED ) of prophylactic infusion of norepinephrine for preventing hypotension during combined spinal-epidural anesthesia for cesarean section in singleton versus twin pregnancies.
A randomized controlled trial was conducted, enrolling 200 pregnant women, 100 of which were of singleton pregnancies while the other 100 were of twin pregnancies, at West China Second University Hospital, Sichuan University between November 3, 2020 and June 2, 2021. All 200 subjects were to have Cesarean section under combined spinal-epidural anesthesia. By using a random number table, they were randomly assigned to five groups, receiving norepinephrine at the infusion dosage of 0.025, 0.050, 0.075, 0.100, and 0.125 μg/(kg·min), with 20 subjects of singleton pregnancy and 20 subjects of twin pregnancy in each group. Norepinephrine infusion started when the anesthesiologist initiated the spinal anesthetic injection and lasted until the delivery of the fetus. The primary outcome measure was the incidence of maternal hypotension during combined spinal-epidural anesthesia, up until the delivery of the fetus. Survival analysis, with survival being defined as not having hypotension, of the incidence of hypotension among the subjects was conducted. Probit regression was used to determine the ED of norepinephrine, as well as the corresponding 95% confidence interval ( ), for preventing hypotension during cesarean delivery under combined spinal-epidural anesthesia in women with singleton and twin pregnancies.
There was no significant difference in the baseline data or the anesthesia and operation data between pregnant women of singleton pregnancy and those of twin pregnancy ( >0.05). In singleton pregnant women receiving 0.025, 0.05, 0.075, 0.1 and 0.125 μg/(kg·min) of norepinephrine, the incidence of hypotension was 50% (10/20), 35% (7/20), 20% (4/20), 10% (2/20) and 5% (1/20), respectively. The estimated ED of prophylactic norepinephrine for preventing hypotension during anesthesia was 0.100 (95% , 0.082-0.130) μg/(kg·min). In twin pregnant women receiving 0.025, 0.05, 0.075, 0.1 and 0.125 μg/(kg·min) of norepinephrine, the corresponding incidence of hypotension was 60% (12/20), 20% (4/20), 20% (4/20), 10% (2/20) and 5% (1/20). The estimated ED of norepinephrine for preventing hypotension during anesthesia was 0.098 (95% , 0.080-0.127) μg/(kg·min). Survival analysis showed significant difference in the incidence of hypotension among the five groups receiving different infusion doses in singleton pregnancy subjects, and the same is true of the twin pregnancy subjects ( <0.05). The incidence of reactive hypertension increased with increasing dosage of norepinephrine in both singleton pregnancy subjects and twin pregnancy subjects ( <0.05). There was no significant difference in the incidence of other maternal adverse reaction or in neonatal outcomes in singleton and twin pregnancy subjects receiving different dosage of norepinephrine ( >0.05). The gestational weeks, weight, and BMI were significantly different ( <0.05), while the other characteristics, including age and height, were comparable ( >0.05) between singleton and twin pregnancy subjects receiving norepinephrine at the same dosage. There was no significant difference in the incidence of hypotension, reactive hypertension, bradycardia, nausea and vomiting, and dizziness between singleton and twin pregnancy subjects receiving the same dose ( >0.05). Survival analysis displayed no significant difference in the incidence of hypotension between singleton and twin pregnancy subjects receiving norepinephrine at the same dosage ( >0.05). There was no significant difference in the ED of norepinephrine between women with singleton pregnancies and those with twin pregnancies ( >0.05).
There was no significant difference in the ED of norepinephrine for preventing hypotension during combined spinal-epidural anesthesia between women with singleton pregnancy and those with twin pregnancy. Interference of other factors, including gestational age, body mass, and BMI should be considered in clinical practice.
确定并比较预防剖宫产腰麻 - 硬膜外联合麻醉期间低血压的去甲肾上腺素预防性输注的90%有效剂量(ED),比较单胎妊娠与双胎妊娠情况。
于2020年11月3日至2021年6月2日在四川大学华西第二医院进行一项随机对照试验,纳入200名孕妇,其中100名单胎妊娠,另100名双胎妊娠。所有200名受试者均接受腰麻 - 硬膜外联合麻醉下的剖宫产手术。通过随机数字表,将她们随机分为五组,分别接受0.025、0.050、0.075、0.100和0.125μg/(kg·min)输注剂量的去甲肾上腺素,每组单胎妊娠和双胎妊娠受试者各20名。当麻醉医生开始腰麻注射时开始输注去甲肾上腺素,持续至胎儿娩出。主要观察指标是腰麻 - 硬膜外联合麻醉期间直至胎儿娩出时产妇低血压的发生率。对受试者低血压发生率进行生存分析,将未发生低血压定义为生存。采用概率回归确定去甲肾上腺素预防腰麻 - 硬膜外联合麻醉剖宫产时低血压的ED及其相应的95%置信区间()。
单胎妊娠孕妇与双胎妊娠孕妇的基线数据、麻醉及手术数据无显著差异(>0.05)。接受0.025、0.05、0.075、0.1和0.125μg/(kg·min)去甲肾上腺素的单胎妊娠孕妇,低血压发生率分别为50%(10/20)、35%(7/20)、20%(4/20)、10%(2/20)和5%(1/20)。预防麻醉期间低血压的去甲肾上腺素估计ED为0.100(95%,0.082 - 0.130)μg/(kg·min)。接受0.025、0.05、0.075、0.1和0.125μg/(kg·min)去甲肾上腺素的双胎妊娠孕妇,相应低血压发生率分别为60%(12/20)、20%(4/20)、20%(4/20)、10%(2/20)和5%(1/20)。预防麻醉期间低血压的去甲肾上腺素估计ED为0.098(95%,0.080 - 0.127)μg/(kg·min)。生存分析显示,单胎妊娠受试者中接受不同输注剂量的五组低血压发生率有显著差异,双胎妊娠受试者亦是如此(<0.05)。单胎妊娠受试者和双胎妊娠受试者中,反应性高血压发生率均随去甲肾上腺素剂量增加而升高(<0.05)。接受不同剂量去甲肾上腺素的单胎妊娠和双胎妊娠受试者中,其他产妇不良反应发生率及新生儿结局无显著差异(>0.05)。接受相同剂量去甲肾上腺素的单胎妊娠和双胎妊娠受试者,孕周、体重和BMI有显著差异(<0.05),而包括年龄和身高在内的其他特征具有可比性(>0.05)。接受相同剂量的单胎妊娠和双胎妊娠受试者,低血压、反应性高血压、心动过缓、恶心呕吐及头晕的发生率无显著差异(>0.05)。生存分析显示,接受相同剂量去甲肾上腺素的单胎妊娠和双胎妊娠受试者低血压发生率无显著差异(>0.05)。单胎妊娠女性与双胎妊娠女性去甲肾上腺素的ED无显著差异(>0.05)。
单胎妊娠女性与双胎妊娠女性在腰麻 - 硬膜外联合麻醉期间预防低血压的去甲肾上腺素ED无显著差异。临床实践中应考虑包括孕周、体重和BMI等其他因素的干扰。