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A randomized double-blind study comparing prophylactic norepinephrine and ephedrine infusion for preventing maternal spinal hypotension during elective cesarean section under spinal anesthesia: A CONSORT-compliant article.
Medicine (Baltimore). 2019 Dec; 98(51):e18311.M

Abstract

BACKGROUND

Studies have shown the efficacy of norepinephrine in the treatment of maternal hypotension during cesarean section by comparing it to treatment with phenylephrine. However, few studies have compared the efficacy of norepinephrine to ephedrine.

METHODS

Ninety-seven women undergoing elective cesarean section were administered norepinephrine at 4 μg/minute (group N; n = 48) or ephedrine at 4 mg/minute (group E; n = 49) immediately postspinal anesthesia, with an on-off titration to maintain systolic blood pressure (SBP) at 80% to 120% of baseline. A rescue bolus of 8 μg norepinephrine was given whenever SBP reached the predefined lower limit. Our primary outcome was the incidence of tachycardia. Secondary outcomes included the incidence of bradycardia, hypertension, hypotension, severe hypotension, hypotensive episodes, number of rescue top-ups, hemodynamic performance error including median performance error (MDPE), and median absolute performance error (MDAPE). Neonatal Apgar scores and umbilical arterial (UA) blood gas data were also collected.

RESULTS

Women in group N experienced fewer cases of tachycardia (4.2% vs 30.6%, P = .002, odds ratio: 0.11 [95% confidence interval, CI: 0.02-0.47]), a lower standardized heart rate (HR) (70.3 ± 11 vs 75 ± 11, P = .04, difference: 4.7 ± 2.2 [95% CI: 0.24-9.1]), and a lower MDPE for HR (1.3 ± 9.6 vs 8.4 ± 13.5 bpm, P = .003, difference: 3.1 ± 1.8 [95% CI: -0.6-6.7]). In addition, the lowest or the highest HR was lower in group N compared to group E (both P < .05). Meanwhile, the standardized SBP in group N was lower than that in group E (P = .04). For neonates, the UA blood gas showed a higher base excess (BE) and a lower lactate level in group N compared to E (both P < .001). Other hemodynamic variables, maternal, and neonatal outcomes were similar.

CONCLUSION

Infusion of 4 μg/minute norepinephrine presented fewer cases of tachycardia, less fluctuation and a lower HR compared to baseline values, as well as a less stressed fetal status compared to ephedrine infusion at 4 mg/minute. In addition, norepinephrine infusion presented a lower standardized SBP compared to ephedrine.

Authors+Show Affiliations

Department of Anesthesiology, Women's Hospital of Nanjing Medical University, Nanjing Maternity and Child Health Care Hospital.Department of Anesthesiology, Women's Hospital of Nanjing Medical University, Nanjing Maternity and Child Health Care Hospital.Department of Anesthesiology, Women's Hospital of Nanjing Medical University, Nanjing Maternity and Child Health Care Hospital.Department of Anesthesiology, Women's Hospital of Nanjing Medical University, Nanjing Maternity and Child Health Care Hospital.Department of Anesthesiology, Women's Hospital of Nanjing Medical University, Nanjing Maternity and Child Health Care Hospital.Department of Anesthesiology, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, P.R. China.Department of Anesthesiology, Women's Hospital of Nanjing Medical University, Nanjing Maternity and Child Health Care Hospital.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

31860981

Citation

Xu, Shiqin, et al. "A Randomized Double-blind Study Comparing Prophylactic Norepinephrine and Ephedrine Infusion for Preventing Maternal Spinal Hypotension During Elective Cesarean Section Under Spinal Anesthesia: a CONSORT-compliant Article." Medicine, vol. 98, no. 51, 2019, pp. e18311.
Xu S, Mao M, Zhang S, et al. A randomized double-blind study comparing prophylactic norepinephrine and ephedrine infusion for preventing maternal spinal hypotension during elective cesarean section under spinal anesthesia: A CONSORT-compliant article. Medicine (Baltimore). 2019;98(51):e18311.
Xu, S., Mao, M., Zhang, S., Qian, R., Shen, X., Shen, J., & Wang, X. (2019). A randomized double-blind study comparing prophylactic norepinephrine and ephedrine infusion for preventing maternal spinal hypotension during elective cesarean section under spinal anesthesia: A CONSORT-compliant article. Medicine, 98(51), e18311. https://doi.org/10.1097/MD.0000000000018311
Xu S, et al. A Randomized Double-blind Study Comparing Prophylactic Norepinephrine and Ephedrine Infusion for Preventing Maternal Spinal Hypotension During Elective Cesarean Section Under Spinal Anesthesia: a CONSORT-compliant Article. Medicine (Baltimore). 2019;98(51):e18311. PubMed PMID: 31860981.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized double-blind study comparing prophylactic norepinephrine and ephedrine infusion for preventing maternal spinal hypotension during elective cesarean section under spinal anesthesia: A CONSORT-compliant article. AU - Xu,Shiqin, AU - Mao,Mao, AU - Zhang,Susu, AU - Qian,Ruifeng, AU - Shen,Xiaofeng, AU - Shen,Jinchun, AU - Wang,Xian, PY - 2019/12/22/entrez PY - 2019/12/22/pubmed PY - 2020/1/8/medline SP - e18311 EP - e18311 JF - Medicine JO - Medicine (Baltimore) VL - 98 IS - 51 N2 - BACKGROUND: Studies have shown the efficacy of norepinephrine in the treatment of maternal hypotension during cesarean section by comparing it to treatment with phenylephrine. However, few studies have compared the efficacy of norepinephrine to ephedrine. METHODS: Ninety-seven women undergoing elective cesarean section were administered norepinephrine at 4 μg/minute (group N; n = 48) or ephedrine at 4 mg/minute (group E; n = 49) immediately postspinal anesthesia, with an on-off titration to maintain systolic blood pressure (SBP) at 80% to 120% of baseline. A rescue bolus of 8 μg norepinephrine was given whenever SBP reached the predefined lower limit. Our primary outcome was the incidence of tachycardia. Secondary outcomes included the incidence of bradycardia, hypertension, hypotension, severe hypotension, hypotensive episodes, number of rescue top-ups, hemodynamic performance error including median performance error (MDPE), and median absolute performance error (MDAPE). Neonatal Apgar scores and umbilical arterial (UA) blood gas data were also collected. RESULTS: Women in group N experienced fewer cases of tachycardia (4.2% vs 30.6%, P = .002, odds ratio: 0.11 [95% confidence interval, CI: 0.02-0.47]), a lower standardized heart rate (HR) (70.3 ± 11 vs 75 ± 11, P = .04, difference: 4.7 ± 2.2 [95% CI: 0.24-9.1]), and a lower MDPE for HR (1.3 ± 9.6 vs 8.4 ± 13.5 bpm, P = .003, difference: 3.1 ± 1.8 [95% CI: -0.6-6.7]). In addition, the lowest or the highest HR was lower in group N compared to group E (both P < .05). Meanwhile, the standardized SBP in group N was lower than that in group E (P = .04). For neonates, the UA blood gas showed a higher base excess (BE) and a lower lactate level in group N compared to E (both P < .001). Other hemodynamic variables, maternal, and neonatal outcomes were similar. CONCLUSION: Infusion of 4 μg/minute norepinephrine presented fewer cases of tachycardia, less fluctuation and a lower HR compared to baseline values, as well as a less stressed fetal status compared to ephedrine infusion at 4 mg/minute. In addition, norepinephrine infusion presented a lower standardized SBP compared to ephedrine. SN - 1536-5964 UR - https://www.unboundmedicine.com/medline/citation/31860981/A_randomized_double_blind_study_comparing_prophylactic_norepinephrine_and_ephedrine_infusion_for_preventing_maternal_spinal_hypotension_during_elective_cesarean_section_under_spinal_anesthesia:_A_CONSORT_compliant_article_ L2 - http://dx.doi.org/10.1097/MD.0000000000018311 DB - PRIME DP - Unbound Medicine ER -