A biased coin up-and-down sequential allocation trial to determine the ED90 of intrathecal sufentanil combined with ropivacaine 2.5 mg for labor analgesia
To determine the 90 percent effective dose (ED90) of intrathecal sufentanil combined with ropivacaine 2.5 mg for labor analgesia and observe its safety for parturients and neonates. We conducted a prospective, double-blind, biased coin up-and-down study. We injected a fixed 2.5 mg ropivacaine combin...
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Published in | Frontiers in medicine Vol. 10; p. 1275605 |
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Abstract | To determine the 90 percent effective dose (ED90) of intrathecal sufentanil combined with ropivacaine 2.5 mg for labor analgesia and observe its safety for parturients and neonates.
We conducted a prospective, double-blind, biased coin up-and-down study. We injected a fixed 2.5 mg ropivacaine combined with a designated dose of sufentanil intrathecally to observe the labor analgesic effect. The initial dose of sufentanil was assigned 1.0 μg, and the remaining doses were assigned as per the biased coin up-and-down method. The criterion of successful response was defined as VAS ≤ 30 mm after intrathecal injection at 10 min. Safety was evaluated in terms of maternal and neonatal outcomes.
The ED90 dose of intrathecal sufentanil combined with ropivacaine 2.5 mg (0.1%, 2.5 mL) was 2.61 μg (95% CI, 2.44 to 2.70 μg) by isotonic regression. No respiratory depression, hypotension, or motor block was observed. Thirty-one (77.5%) parturients complained of pruritus, and 14 (35.0%) suffered nausea and vomiting. Three neonates reported a 1 min Apgar score of ≤7, and none reported a 5 min Apgar score of ≤7.
The ED90 of intrathecal sufentanil combined with ropivacaine 2.5 mg for labor analgesia was 2.61 μg. The dose is safe for parturients and neonates. |
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AbstractList | To determine the 90 percent effective dose (ED90) of intrathecal sufentanil combined with ropivacaine 2.5 mg for labor analgesia and observe its safety for parturients and neonates.
We conducted a prospective, double-blind, biased coin up-and-down study. We injected a fixed 2.5 mg ropivacaine combined with a designated dose of sufentanil intrathecally to observe the labor analgesic effect. The initial dose of sufentanil was assigned 1.0 μg, and the remaining doses were assigned as per the biased coin up-and-down method. The criterion of successful response was defined as VAS ≤ 30 mm after intrathecal injection at 10 min. Safety was evaluated in terms of maternal and neonatal outcomes.
The ED90 dose of intrathecal sufentanil combined with ropivacaine 2.5 mg (0.1%, 2.5 mL) was 2.61 μg (95% CI, 2.44 to 2.70 μg) by isotonic regression. No respiratory depression, hypotension, or motor block was observed. Thirty-one (77.5%) parturients complained of pruritus, and 14 (35.0%) suffered nausea and vomiting. Three neonates reported a 1 min Apgar score of ≤7, and none reported a 5 min Apgar score of ≤7.
The ED90 of intrathecal sufentanil combined with ropivacaine 2.5 mg for labor analgesia was 2.61 μg. The dose is safe for parturients and neonates. PurposeTo determine the 90 percent effective dose (ED90) of intrathecal sufentanil combined with ropivacaine 2.5 mg for labor analgesia and observe its safety for parturients and neonates.MethodsWe conducted a prospective, double-blind, biased coin up-and-down study. We injected a fixed 2.5 mg ropivacaine combined with a designated dose of sufentanil intrathecally to observe the labor analgesic effect. The initial dose of sufentanil was assigned 1.0 μg, and the remaining doses were assigned as per the biased coin up-and-down method. The criterion of successful response was defined as VAS ≤ 30 mm after intrathecal injection at 10 min. Safety was evaluated in terms of maternal and neonatal outcomes.ResultsThe ED90 dose of intrathecal sufentanil combined with ropivacaine 2.5 mg (0.1%, 2.5 mL) was 2.61 μg (95% CI, 2.44 to 2.70 μg) by isotonic regression. No respiratory depression, hypotension, or motor block was observed. Thirty-one (77.5%) parturients complained of pruritus, and 14 (35.0%) suffered nausea and vomiting. Three neonates reported a 1 min Apgar score of ≤7, and none reported a 5 min Apgar score of ≤7.ConclusionThe ED90 of intrathecal sufentanil combined with ropivacaine 2.5 mg for labor analgesia was 2.61 μg. The dose is safe for parturients and neonates. Purpose To determine the 90 percent effective dose (ED90) of intrathecal sufentanil combined with ropivacaine 2.5 mg for labor analgesia and observe its safety for parturients and neonates. Methods We conducted a prospective, double-blind, biased coin up-and-down study. We injected a fixed 2.5 mg ropivacaine combined with a designated dose of sufentanil intrathecally to observe the labor analgesic effect. The initial dose of sufentanil was assigned 1.0 μg, and the remaining doses were assigned as per the biased coin up-and-down method. The criterion of successful response was defined as VAS ≤ 30 mm after intrathecal injection at 10 min. Safety was evaluated in terms of maternal and neonatal outcomes. Results The ED90 dose of intrathecal sufentanil combined with ropivacaine 2.5 mg (0.1%, 2.5 mL) was 2.61 μg (95% CI, 2.44 to 2.70 μg) by isotonic regression. No respiratory depression, hypotension, or motor block was observed. Thirty-one (77.5%) parturients complained of pruritus, and 14 (35.0%) suffered nausea and vomiting. Three neonates reported a 1 min Apgar score of ≤7, and none reported a 5 min Apgar score of ≤7. Conclusion The ED90 of intrathecal sufentanil combined with ropivacaine 2.5 mg for labor analgesia was 2.61 μg. The dose is safe for parturients and neonates. |
Author | Li, Gang Yin, Qiaoli Sun, Junyan Yu, Bin Hao, Hua Deng, Liqin Kong, Hao |
AuthorAffiliation | 3 Department of Anesthesiology, Guolong Hospital , Yinchuan , China 4 Department of Anesthesiology, Peking University First Hospital , Beijing , China 1 Department of Anesthesiology, General Hospital of Ningxia Medical University , Yinchuan , China 2 Department of Anesthesiology, Peking University First Hospital, Ningxia Women’s and Children’s Hospital , Yinchuan , China |
AuthorAffiliation_xml | – name: 1 Department of Anesthesiology, General Hospital of Ningxia Medical University , Yinchuan , China – name: 3 Department of Anesthesiology, Guolong Hospital , Yinchuan , China – name: 2 Department of Anesthesiology, Peking University First Hospital, Ningxia Women’s and Children’s Hospital , Yinchuan , China – name: 4 Department of Anesthesiology, Peking University First Hospital , Beijing , China |
Author_xml | – sequence: 1 givenname: Qiaoli surname: Yin fullname: Yin, Qiaoli organization: Department of Anesthesiology, Peking University First Hospital, Ningxia Women's and Children's Hospital, Yinchuan, China – sequence: 2 givenname: Bin surname: Yu fullname: Yu, Bin organization: Department of Anesthesiology, Peking University First Hospital, Ningxia Women's and Children's Hospital, Yinchuan, China – sequence: 3 givenname: Hua surname: Hao fullname: Hao, Hua organization: Department of Anesthesiology, Peking University First Hospital, Ningxia Women's and Children's Hospital, Yinchuan, China – sequence: 4 givenname: Gang surname: Li fullname: Li, Gang organization: Department of Anesthesiology, Peking University First Hospital, Ningxia Women's and Children's Hospital, Yinchuan, China – sequence: 5 givenname: Junyan surname: Sun fullname: Sun, Junyan organization: Department of Anesthesiology, Guolong Hospital, Yinchuan, China – sequence: 6 givenname: Hao surname: Kong fullname: Kong, Hao organization: Department of Anesthesiology, Peking University First Hospital, Beijing, China – sequence: 7 givenname: Liqin surname: Deng fullname: Deng, Liqin organization: Department of Anesthesiology, General Hospital of Ningxia Medical University, Yinchuan, China |
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Cites_doi | 10.1213/00000539-199809000-00025 10.1016/j.accpm.2021.100939 10.1002/14651858.CD003401.pub3 10.1213/00000539-199908000-00024 10.1111/j.1399-6576.2010.02254.x 10.1093/bja/aen313 10.1097/01.anes.0000267514.42592.2a 10.3390/jcm12010181 10.1016/j.jclinane.2017.09.003 10.1186/s12871-019-0855-y 10.1213/ANE.0000000000001046 10.1093/bja/87.5.733 10.1213/01.ANE.0000101980.34587.66 10.1213/ANE.0000000000001412 10.1097/AOG.0000000000003132 10.1097/00000542-200503000-00025 10.1186/1741-7015-8-18 10.1007/BF03011037 10.1016/j.ijoa.2003.07.001 10.1213/00000539-199706000-00016 10.1213/ANE.0000000000001798 10.1097/ALN.0000000000000118 10.1007/s00540-022-03061-8 10.5812/aapm.113350 10.1016/j.ajog.2022.05.031 10.1097/00000542-200006000-00011 |
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Keywords | intrathecal sufentanil biased coin up-and-down labor analgesia ED90 |
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SubjectTerms | biased coin up-and-down ED90 intrathecal labor analgesia Medicine sufentanil |
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Title | A biased coin up-and-down sequential allocation trial to determine the ED90 of intrathecal sufentanil combined with ropivacaine 2.5 mg for labor analgesia |
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