Cargando…
The efficacy and safety of intrathecal dexmedetomidine for parturients undergoing cesarean section: a double-blind randomized controlled trial
BACKGROUND: The efficacy and safety of spinal anesthesia by intrathecal dexmedetomidine (DEX) for parturients undergoing cesarean section are still lack of evidence. This aim of our study was to evaluate the efficacy and safety of intrathecal DEX for parturients undergoing cesarean section to provid...
Autores principales: | , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7397624/ https://www.ncbi.nlm.nih.gov/pubmed/32746864 http://dx.doi.org/10.1186/s12871-020-01109-4 |
_version_ | 1783565806166081536 |
---|---|
author | Li, Xiao-xiao Li, Yu-mei Lv, Xue-li Wang, Xing-he Liu, Su |
author_facet | Li, Xiao-xiao Li, Yu-mei Lv, Xue-li Wang, Xing-he Liu, Su |
author_sort | Li, Xiao-xiao |
collection | PubMed |
description | BACKGROUND: The efficacy and safety of spinal anesthesia by intrathecal dexmedetomidine (DEX) for parturients undergoing cesarean section are still lack of evidence. This aim of our study was to evaluate the efficacy and safety of intrathecal DEX for parturients undergoing cesarean section to provide more data evidence for intrathecal applications. METHODS: Three hundred parturients undergoing cesarean section under spinal anesthesia were randomly assigned into three groups: group B: 9.0 mg (1.2 ml) of 0.75% bupivacaine with saline (1 ml); group FB: 9.0 mg (1.2 ml) of 0.75% bupivacaine with 20 μg of fentanyl (1 ml); group DB: 9.0 mg (1.2 ml) of 0.75% bupivacaine with 5 μg of DEX (1 ml). Intraoperative block characteristics, parturients’ postoperative quality of recovery, maternal and neonatal outcomes and the plasma concentration of DEX were measured. All parturients were followed up for 30 days to determine whether nerve injury occurred. RESULTS: Compared with group B, the duration of sensory block in group FB and group DB were significantly prolonged (108.4 min [95% Confidence Interval (CI) = 104.6–112.3] in group B, and 122.0 min [95% CI = 116.8–127.3] in group FB, 148.2 min [95% CI = 145.3–151.1] in group DB). The overall score of quality recovery in group DB (71.6 [95% CI = 71.0–72.2]) was significantly higher than that in group FB (61.5 [95% CI = 60.8–62.2]) and group B (61.7 [95% CI = 61.0–62.4]). There was no statistically significant difference among the three groups for PH, PaO(2), and PaCO(2) of newborn. The plasma concentration of DEX in umbilical artery and umbilical vein was low and cannot be detected. The 30-days follow-up of parturients did not show any new onset of back, buttock or leg pain or paresthesia. CONCLUSIONS: DEX is a potential local anesthetic adjuvant that the intrathecal combination of 5 μg DEX can safely exhibit a facilitatory block effect and improve parturients’ recovery quality. TRIAL REGISTRATION: Chinese Clinical Trial Registry (Registration number # ChiCTR1900022019; Date of Registration on March 20th, 2019). |
format | Online Article Text |
id | pubmed-7397624 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-73976242020-08-06 The efficacy and safety of intrathecal dexmedetomidine for parturients undergoing cesarean section: a double-blind randomized controlled trial Li, Xiao-xiao Li, Yu-mei Lv, Xue-li Wang, Xing-he Liu, Su BMC Anesthesiol Research Article BACKGROUND: The efficacy and safety of spinal anesthesia by intrathecal dexmedetomidine (DEX) for parturients undergoing cesarean section are still lack of evidence. This aim of our study was to evaluate the efficacy and safety of intrathecal DEX for parturients undergoing cesarean section to provide more data evidence for intrathecal applications. METHODS: Three hundred parturients undergoing cesarean section under spinal anesthesia were randomly assigned into three groups: group B: 9.0 mg (1.2 ml) of 0.75% bupivacaine with saline (1 ml); group FB: 9.0 mg (1.2 ml) of 0.75% bupivacaine with 20 μg of fentanyl (1 ml); group DB: 9.0 mg (1.2 ml) of 0.75% bupivacaine with 5 μg of DEX (1 ml). Intraoperative block characteristics, parturients’ postoperative quality of recovery, maternal and neonatal outcomes and the plasma concentration of DEX were measured. All parturients were followed up for 30 days to determine whether nerve injury occurred. RESULTS: Compared with group B, the duration of sensory block in group FB and group DB were significantly prolonged (108.4 min [95% Confidence Interval (CI) = 104.6–112.3] in group B, and 122.0 min [95% CI = 116.8–127.3] in group FB, 148.2 min [95% CI = 145.3–151.1] in group DB). The overall score of quality recovery in group DB (71.6 [95% CI = 71.0–72.2]) was significantly higher than that in group FB (61.5 [95% CI = 60.8–62.2]) and group B (61.7 [95% CI = 61.0–62.4]). There was no statistically significant difference among the three groups for PH, PaO(2), and PaCO(2) of newborn. The plasma concentration of DEX in umbilical artery and umbilical vein was low and cannot be detected. The 30-days follow-up of parturients did not show any new onset of back, buttock or leg pain or paresthesia. CONCLUSIONS: DEX is a potential local anesthetic adjuvant that the intrathecal combination of 5 μg DEX can safely exhibit a facilitatory block effect and improve parturients’ recovery quality. TRIAL REGISTRATION: Chinese Clinical Trial Registry (Registration number # ChiCTR1900022019; Date of Registration on March 20th, 2019). BioMed Central 2020-08-03 /pmc/articles/PMC7397624/ /pubmed/32746864 http://dx.doi.org/10.1186/s12871-020-01109-4 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Article Li, Xiao-xiao Li, Yu-mei Lv, Xue-li Wang, Xing-he Liu, Su The efficacy and safety of intrathecal dexmedetomidine for parturients undergoing cesarean section: a double-blind randomized controlled trial |
title | The efficacy and safety of intrathecal dexmedetomidine for parturients undergoing cesarean section: a double-blind randomized controlled trial |
title_full | The efficacy and safety of intrathecal dexmedetomidine for parturients undergoing cesarean section: a double-blind randomized controlled trial |
title_fullStr | The efficacy and safety of intrathecal dexmedetomidine for parturients undergoing cesarean section: a double-blind randomized controlled trial |
title_full_unstemmed | The efficacy and safety of intrathecal dexmedetomidine for parturients undergoing cesarean section: a double-blind randomized controlled trial |
title_short | The efficacy and safety of intrathecal dexmedetomidine for parturients undergoing cesarean section: a double-blind randomized controlled trial |
title_sort | efficacy and safety of intrathecal dexmedetomidine for parturients undergoing cesarean section: a double-blind randomized controlled trial |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7397624/ https://www.ncbi.nlm.nih.gov/pubmed/32746864 http://dx.doi.org/10.1186/s12871-020-01109-4 |
work_keys_str_mv | AT lixiaoxiao theefficacyandsafetyofintrathecaldexmedetomidineforparturientsundergoingcesareansectionadoubleblindrandomizedcontrolledtrial AT liyumei theefficacyandsafetyofintrathecaldexmedetomidineforparturientsundergoingcesareansectionadoubleblindrandomizedcontrolledtrial AT lvxueli theefficacyandsafetyofintrathecaldexmedetomidineforparturientsundergoingcesareansectionadoubleblindrandomizedcontrolledtrial AT wangxinghe theefficacyandsafetyofintrathecaldexmedetomidineforparturientsundergoingcesareansectionadoubleblindrandomizedcontrolledtrial AT liusu theefficacyandsafetyofintrathecaldexmedetomidineforparturientsundergoingcesareansectionadoubleblindrandomizedcontrolledtrial AT lixiaoxiao efficacyandsafetyofintrathecaldexmedetomidineforparturientsundergoingcesareansectionadoubleblindrandomizedcontrolledtrial AT liyumei efficacyandsafetyofintrathecaldexmedetomidineforparturientsundergoingcesareansectionadoubleblindrandomizedcontrolledtrial AT lvxueli efficacyandsafetyofintrathecaldexmedetomidineforparturientsundergoingcesareansectionadoubleblindrandomizedcontrolledtrial AT wangxinghe efficacyandsafetyofintrathecaldexmedetomidineforparturientsundergoingcesareansectionadoubleblindrandomizedcontrolledtrial AT liusu efficacyandsafetyofintrathecaldexmedetomidineforparturientsundergoingcesareansectionadoubleblindrandomizedcontrolledtrial |