Dataset Information

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, PaO₂, and PaCO₂ 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).

SUBMITTER: Li XX

PROVIDER: S-EPMC7397624 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Publications

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

Li Xiao-Xiao XX Li Yu-Mei YM Lv Xue-Li XL Wang Xing-He XH Liu Su S

BMC anesthesiology 20200803 1

<h4>Background</h4>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.<h4>Methods</h4>Three hundred parturients undergoing cesarean section under spinal anesthesia were randomly assigned into three groups: group B ...[more]

PMID: 32746864

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Project description:Objective:In this study, we aim to investigate the effect of different doses of dexmedetomidine as an adjuvant to hyperbaric ropivacaine in spinal anesthesia for cesarean section. Methods:Seventy-five parturients with American Society of Anesthesiologists (ASA) I or II were anesthetized with intrathecal ropivacaine (12.5 mg) alone (R group) or in combination with dexmedetomidine 3 ?g (RD3 group) and 5 ?g (RD5 group) to undergo a cesarean section. The anesthetic parameters, postoperative analgesia, stress responses and neonates outcomes were monitored. Results:The onset time of sensory block to T10, T4, and peak level in the RD3 group and RD5 group were significantly shorter than those in the R group (p < 0.05). The time of the level of sensory block to descend two segments and to T10 in the RD3 group(57.28 ± 16.65 min, 3.87 ± 1.60 h) and RD5 group (71.92 ± 10.10 min, 3.99 ± 1.06 h) were longer than that in the R group (40.64 ± 12.06 min, 1.98 ± 1.01 h) (p < 0.05). The median time of motor blockade to both legs score 3 on the Bromage scale (B3B3) in the RD3 group and RD5 group was shorter than that in the R group (p < 0.001). The time of motor blockade recovery to both legs score 0 on the Bromage scale (B0B0) in the RD5 group (3.6 h) was longer than that in the R group (2 h) or RD3 group (2.2 h) (p < 0.001). Visceral traction response and abdominal muscle relaxation during the operation in the RD3 group and the RD5 group were better than that in the R group. The Visual Analogue Score (VAS) in the 12 h after the operation in the RD3 group (3.30 ± 1.17) and RD5 group (2.80 ± 0.87) was smaller than that in the R group (3.80 ± 1.47) (p < 0.05). The incidence of shivering in the RD3 group and RD5 group was significantly lower than that in the R group (p < 0.05). The postoperative concentrations of c-reactive protein (CRP), interleukin-6 (IL-6) and cortisol in the RD3 and RD5 groups were lower than that in the R group (p < 0.05). Conclusion:3 µg intrathecal dexmedetomidine as an adjuvant to ropivacaine improved intraoperative somato-visceral sensory block characteristics and postoperative analgesia, alleviated shivering in parturients, and did not prolong the time of motor block or produce any side effects, which makes this dose appropriate for cesarean delivery. Cinical Trial Registration:ChiCTR, identifier ChiCTR1800014454. Registered 15 January 2018, http://www.chictr.org.cn/edit.aspx?pid=24613&htm=4.

Project description:Objective:Few studies have investigated the effects of dexmedetomidine (DEX) on breastfeeding after cesarean delivery. A randomized double-blind controlled trial was conducted to investigate whether the administration of DEX, immediately after delivery and for patient-controlled intravenous analgesia (PCIA), can be beneficial for breastfeeding. Patients and Methods:One hundred sixty parturients scheduled for elective cesarean section under spinal anesthesia were randomly allocated to the DEX group (a loading dose of DEX was pumped at 0.5 ?g/kg within 10 min, followed by a further infusion of DEX at 0.5 ?g/kg/h until the end of the surgery and PCIA for 2 days with DEX plus sufentanil) or the standard care group (infusion saline intraoperatively, and PCIA for 2 days with sufentanil). The number of days required to switch to exclusive breastfeeding within six weeks of delivery, the time to first lactation and breast milk volume on day 1 and day 2 after delivery were recorded. Recovery quality, comfort, anxiety, depression, postoperative analgesia, and adverse reactions of parturients were also assessed. Results:Compared with the standard care group, parturients in the DEX group could be converted to exclusive breastfeeding earlier (11 [14] vs 8 [10] days, log-rank P=0.025), the first lactation time was sooner (28.38 [13.82] vs 33.79 [14.85] hrs, P=0.024), and the amount of breast milk on the second day after delivery increased (P=0.012). There was no difference between the two groups in postpartum uterine contraction pain, but postpartum rest and movement VAS scores and recovery quality score in the DEX group were better than those in the standard care group (all P<0.05). Moreover, the hospital anxiety and depression scale and anxiety subscale score on the second day after delivery and the comfort score on the third day after delivery in the DEX group were significantly better than those in the standard care group (5 [5] vs 6 [8], 2 [2] vs 3 [3], 83.58 [6.75] vs 80.48 [6.58]; P=0.013, P=0.005, P=0.006, respectively). The incidence of adverse events, such as bradycardia, vomiting, hypersomnia, hypertension and hypotension, was not significantly different between the DEX and standard care groups (6.9% vs 2.7%, 5.6% vs 13.7%, 4.2% vs 0%, 5.6% vs 2.7%, 11.1% vs 8.2%; P=0.275, P=0.158, P=0.366, P=0.681, P=0.556, respectively), except more parturients experienced nausea in the standard care group than in the DEX group (28.8% vs 11.1%, P=0.012). Furthermore, there was no difference in Neonatal Behavioral Neurological Assessment scores on the first and second days after delivery between the DEX and standard care groups (38 [3] vs 37 [2], 38.5 [2] vs 38 [2]; P=0.173, P=0.312, respectively). Conclusion:The application of DEX in the perioperative period of cesarean section was not only conducive to the early conversion of infant feeding to exclusive breastfeeding but could also improve the recovery quality and comfort of the parturient, optimize analgesia, shorten the time to first lactation, and increase lactation. Clinical Trials Registration:NCT03805945.

Project description:Background and purposeAdding adjuvants to intrathecal hyperbaric bupivacaine provides long analgesic duration with less adverse effects. The aim of this study was to compare intrathecal nalbuphine versus midazolam in patients undergoing cesarean section.Clinical trial idNCT03918187.Patients and methodsThis was a prospective randomized controlled study conducted on 90 females undergoing cesarean section under spinal anesthesia who were randomly allocated to three equal groups of 30 patients each: group C received hyperbaric bupivacaine 12.5 mg plus 0.5 mL saline, group N received hyperbaric bupivacaine 12.5 mg plus 1 mg nalbuphine, group M received hyperbaric bupivacaine 12.5 mg plus 2.5 mg midazolam. The onset and duration of sensory and motor block, effective analgesic time, analgesic requirements, adverse effects, sedation, and Apgar scores were recorded.ResultsThere was significant rapid onset of sensory and motor block (1.95±.44 and 3.50±0.43 min) with slower regression of sensory block and time to bromage I (211.6±13.2 and 219.8±20.2 min) in group N compared to groups M, C (p < 0.001), with statistically significant rapid onset and long duration of both blocks in group M compared to C (p<0.001). The effective analgesic time was significantly prolonged in group N (263.7±16.3) compared to groups M and C (224.2 ± 18.6, 185.5±17.45), respectively, (p<0.001) and prolonged in group M compared to C (p<0.001), with increase in analgesic requirement in group C compared to groups N and M (p<0.001) and no significant difference between groups N and M. There was higher sedation score in groups N, M (1.78±0.63, 2.75±0.54), respectively, compared to group C (0.61±0.12) (p<0.001) with lower Apgar score in group M (6.9±0.73) at one minute than in groups N, C (7.1±0.91, 7.7±0.84) (p<0.001). There was no significant difference between groups regarding the adverse effects.ConclusionAdding 1 mg nalbuphine to 12.5 mg hyperbaric bupivacaine provided more effective postoperative analgesia than adding 2.5 mg midazolam, with less non-significant adverse effects in midazolam group in patients undergoing elective cesarean section.

Dataset Information

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

Background

Methods

Results

Conclusions

Trial registration

Publications

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

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