The efficacy and safety of intrathecal dexmedetomidine for parturients undergoing cesarean section: a double-blind randomized controlled trial

Abstract

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.

Eficacia y seguridad de la anestesia multimodal intratecal con fentanilo en cesárea: ensayo clínico

“…El fentanilo como único agente anestésico intratecal resulta muy efectivo en el primer período del trabajo de parto debido a su actividad sobre las fibras nerviosas tipo C que se encuentran a nivel visceral (15,16) . Diferentes estudios del fentanilo con altas y bajas dosis de bupivacaína hiperbárica, con morfina y dexmedetomidina no han logrado demostrar la reducción de aparición de hipotensión, molestias transoperatorias ni efectos secundarios (17)(18)(19)(20)(21)(22)(23)(24) . Hacen falta más estudios para apoyar los resultados del presente estudio.…”

A Systematic Review and Meta-analysis of Efficacy and Safety of Dexmedetomidine Combined With Intrathecal Bupivacaine Compared to Placebo

“… Al-Mustafa et al 2009 [ 11 ], Gautam et al 2017 [ 12 ], Kanazi et al [ 13 ], Karimi et al 2021 [ 14 ], Liu et al 2019 [ 18 ], Li et al 2020 [ 16 ], Li et al 2015 [ 17 ], Kim et al 2013 [ 15 ], Mostafa et al [ 20 ], Nwachukwu et al 2020 [ 21 ], Mohamed et al 2012 [ 19 ], Omar et al 2019 [ 22 ], Qi et al 2016 [ 23 ], Rahimzadeh et al 2018 [ 24 ], Solanki et al 2013 [ 25 ], Sun et al 2015 [ 27 ], Xia et al 2018 [ 28 ], Yektas et al 2014 [ 29 ], Yousef et al 2015 [ 30 ], Abdel-Ghaffar et al 2016 [ 10 ], Samantaray et al 2015 [ 26 ]. …”

“… Abdel-Ghaffar et al 2016 [ 10 ], Gautam et al 2017 [ 12 ], Al-Mustafa et al 2009 [ 11 ], Kanazi et al [ 13 ], Karimi et al 2021 [ 14 ], Li et al 2020 [ 16 ], Liu et al 2019 [ 18 ], Mostafa et al [ 20 ], Nwachukwu et al 2020 [ 21 ], Omar et al 2019 [ 22 ], Rahimzadeh et al 2018 [ 24 ], Sun et al 2015 [ 27 ], Xia et al 2018 [ 28 ], Yektas et al 2014 [ 29 ], Yousef et al 2015 [ 30 ], Qi et al 2016 [ 23 ], Mohamed et al 2012 [ 19 ], Kim et al 2013 [ 15 ], Solanki et al 2013 [ 25 ], Samantaray et al 2015 [ 26 ] Li et al 2015 [ 17 ] …”

“… Al-Mustafa et al 2009 [ 11 ], Gautam et al 2017 [ 12 ], Kanazi et al [ 13 ], Liu et al 2019 [ 18 ], Li et al 2020 [ 16 ], Mostafa et al [ 20 ], Omar et al 2019 [ 22 ], Qi et al 2016 [ 23 ], Rahimzadeh et al 2018 [ 24 ], Solanki et al 2013 [ 25 ], Sun et al 2015 [ 27 ], Xia et al 2018 [ 28 ], Yektas et al 2014 [ 29 ], Samantaray et al 2015 [ 26 ]

Figure 6 Comparison of adverse effects dexmedetomidine with placebo. Abdel-Ghaffar et al 2016 [ 10 ], Al-Mustafa et al 2009 [ 11 ], Gautam et al 2017 [ 12 ], Karimi et al 2021 [ 14 ], Kim et al 2013 [ 15 ], Liu et al 2019 [ 18 ], Li et al 2020 [ 16 ], Mohamed et al 2012 [ 19 ], Nwachukwu et al 2020 [ 21 ], Omar et al 2019 [ 22 ], Qi et al 2016 [ 23 ], Rahimzadeh et al 2018 [ 24 ], Samantaray et al 2015 [ 26 ], Solanki et al 2013 [ 25 ], Sun et al 2015 [ 27 ], Xia et al 2018 [ 28 ], Yektas et al 2014 [ 29 ], Yousef et al 2015 [ 30 ]

…”

“… Abdel-Ghaffar et al 2016 [ 10 ], Al-Mustafa et al 2009 [ 11 ], Gautam et al 2017 [ 12 ], Karimi et al 2021 [ 14 ], Kim et al 2013 [ 15 ], Liu et al 2019 [ 18 ], Li et al 2020 [ 16 ], Mohamed et al 2012 [ 19 ], Nwachukwu et al 2020 [ 21 ], Omar et al 2019 [ 22 ], Qi et al 2016 [ 23 ], Rahimzadeh et al 2018 [ 24 ], Samantaray et al 2015 [ 26 ], Solanki et al 2013 [ 25 ], Sun et al 2015 [ 27 ], Xia et al 2018 [ 28 ], Yektas et al 2014 [ 29 ], Yousef et al 2015 [ 30 ] …”