BMJ open · 2024
Esketamine administered epidurally as an adjuvant to epidural ropivacaine for labour analgesia: a prospective, double-blind dose-response study.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Xu Lili, Li Shuxi, Zhang Chenghong, Zhou Yanhong, Chen Xinzhong
Аннотация
OBJECTIVE: To investigate the efficacy of esketamine as an adjuvant to epidural ropivacaine for labour analgesia by determining its effect on the median effective concentration (EC50) in a 20 ml volume of ropivacaine.
DESIGN: A prospective, double-blind dose-response study.
SETTING: This study was conducted in Women's Hospital, School of Medicine, Zhejiang University, China.
PARTICIPANTS: One hundred and fifty parturients who requested epidural analgesia were recruited in this study to randomly receive epidural ropivacaine alone or with esketamine of 0.2 mg ml-1, 0.3 mg ml-1, 0.4 mg ml-1 or 0.5 mg ml-1, respectively.
PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome, EC50 of ropivacaine, was determined using an up-down sequential allocation technique. The secondary outcomes were analgesia characteristics, Ramsay Sedation Scale score, labour duration, caesarean section rate and adverse effects.
RESULTS: The EC50 of ropivacaine with the addition of esketamine at concentrations of 0.3 mg ml-1, 0.4 mg ml-1 and 0.5 mg ml-1 resulted in significant reductions in the EC50 of ropivacaine to 0.050%, 0.044% and 0.043%, respectively, from baseline (esketamine 0 mg ml-1) (p<0.0001). However, reductions of the EC50 of ropivacaine were similar among the groups with esketamine of 0.3 mg ml-1, 0.4 mg ml-1 and 0.5 mg ml-1 (p>0.05). The Ramsay Sedation Scale score was higher and more dizziness was observed in the Group of esketamine 0.5 mg ml-1 compared with all other groups (p<0.0001). During the peripartum period, no differences in sensory blockade level, Bromage score, labour duration and percentage of caesarean delivery were found among the groups.
CONCLUSIONS: Under the conditions of this study, the addition of epidural esketamine of 0.3 mg⋅mL-1, 0.4 mg⋅mL-1 and 0.5 mg⋅mL-1 offered a similar ropivacaine dose-sparing effect; 0.5 mg⋅mL-1 of esketamine produced more adverse effects.
TRIAL REGISTRATION NUMBER: ChiCTR2100054348.
DESIGN: A prospective, double-blind dose-response study.
SETTING: This study was conducted in Women's Hospital, School of Medicine, Zhejiang University, China.
PARTICIPANTS: One hundred and fifty parturients who requested epidural analgesia were recruited in this study to randomly receive epidural ropivacaine alone or with esketamine of 0.2 mg ml-1, 0.3 mg ml-1, 0.4 mg ml-1 or 0.5 mg ml-1, respectively.
PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome, EC50 of ropivacaine, was determined using an up-down sequential allocation technique. The secondary outcomes were analgesia characteristics, Ramsay Sedation Scale score, labour duration, caesarean section rate and adverse effects.
RESULTS: The EC50 of ropivacaine with the addition of esketamine at concentrations of 0.3 mg ml-1, 0.4 mg ml-1 and 0.5 mg ml-1 resulted in significant reductions in the EC50 of ropivacaine to 0.050%, 0.044% and 0.043%, respectively, from baseline (esketamine 0 mg ml-1) (p<0.0001). However, reductions of the EC50 of ropivacaine were similar among the groups with esketamine of 0.3 mg ml-1, 0.4 mg ml-1 and 0.5 mg ml-1 (p>0.05). The Ramsay Sedation Scale score was higher and more dizziness was observed in the Group of esketamine 0.5 mg ml-1 compared with all other groups (p<0.0001). During the peripartum period, no differences in sensory blockade level, Bromage score, labour duration and percentage of caesarean delivery were found among the groups.
CONCLUSIONS: Under the conditions of this study, the addition of epidural esketamine of 0.3 mg⋅mL-1, 0.4 mg⋅mL-1 and 0.5 mg⋅mL-1 offered a similar ropivacaine dose-sparing effect; 0.5 mg⋅mL-1 of esketamine produced more adverse effects.
TRIAL REGISTRATION NUMBER: ChiCTR2100054348.