Dataset Information

Intrathecal dexmedetomidine as an adjuvant to plain ropivacaine for spinal anesthesia during cesarean section: a prospective, double-blinded, randomized trial for ED₅₀ determination using an up-down sequential allocation method.

ABSTRACT:

Background

Intrathecal dexmedetomidine, as an adjuvant to local anesthetics, has been reported to improve the quality of spinal anesthesia and reduce the required local anesthetic dose. However, the optimal dosage regimen for intrathecal dexmedetomidine combined with plain ropivacaine for cesarean section (CS) remains undetermined. The present study aimed to determine the median effective dose (ED₅₀) of intrathecal dexmedetomidine as an adjuvant to plain ropivacaine for spinal anesthesia during CS.

Methods

Sixty parturients undergoing CS were randomly assigned to either group: plain ropivacaine 8 mg (Group Rop₈) or plain ropivacaine 10 mg (Group Rop₁₀). The initial dosage of intrathecal dexmedetomidine in each group was 5 µg. The effective dose was defined as a bilateral sensory block at the level of T6 or above to pinprick attained within 10 min after intrathecal injection, without the need for supplementary intraoperative epidural anesthesia. Effective or ineffective responses were determined, followed by a 1 µg increment or decrement in the dose of intrathecal dexmedetomidine for the next parturient using up-down sequential allocation. ED₅₀ were calculated using probit regression.

Results

The ED₅₀ of intrathecal dexmedetomidine with plain ropivacaine was 5.9 µg (95% confidence interval [CI], 4.9-7.4 µg) in Group Rop₈ and 3.1 µg (95% CI, 0.1-4.8 µg) in Group Rop₁₀ (P < 0.05). Hemodynamic stability, side effects, patient satisfaction and neonatal outcomes were comparable between the two groups.

Conclusions

The present data suggested that the ED₅₀ of intrathecal dexmedetomidine as an adjuvant to 8 mg and 10 mg plain ropivacaine in spinal anesthesia during cesarean section was approximately 6 µg and 3 µg, respectively.

Trial registration

Chinese Clinical Trial Registry, identifier: ChiCTR2200055928.

SUBMITTER: Mo X

PROVIDER: S-EPMC10519004 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Intrathecal dexmedetomidine as an adjuvant to plain ropivacaine for spinal anesthesia during cesarean section: a prospective, double-blinded, randomized trial for ED<sub>50</sub> determination using an up-down sequential allocation method.

Mo Xiaofei X Huang Fa F Wu Xiaoying X Feng Jumian J Zeng Jiequn J Chen Jinghui J

BMC anesthesiology 20230925 1

<h4>Background</h4>Intrathecal dexmedetomidine, as an adjuvant to local anesthetics, has been reported to improve the quality of spinal anesthesia and reduce the required local anesthetic dose. However, the optimal dosage regimen for intrathecal dexmedetomidine combined with plain ropivacaine for cesarean section (CS) remains undetermined. The present study aimed to determine the median effective dose (ED<sub>50</sub>) of intrathecal dexmedetomidine as an adjuvant to plain ropivacaine for spinal ...[more]

PMID: 37749533

Similar Datasets

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:BackgroundThe 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.MethodsThree 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.ResultsCompared 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.ConclusionsDEX 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 registrationChinese Clinical Trial Registry (Registration number # ChiCTR1900022019 ; Date of Registration on March 20th, 2019).

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

Intrathecal dexmedetomidine as an adjuvant to plain ropivacaine for spinal anesthesia during cesarean section: a prospective, double-blinded, randomized trial for ED₅₀ determination using an up-down sequential allocation method.

Background

Methods

Results

Conclusions

Trial registration

Publications

Intrathecal dexmedetomidine as an adjuvant to plain ropivacaine for spinal anesthesia during cesarean section: a prospective, double-blinded, randomized trial for ED<sub>50</sub> determination using an up-down sequential allocation method.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

Intrathecal dexmedetomidine as an adjuvant to plain ropivacaine for spinal anesthesia during cesarean section: a prospective, double-blinded, randomized trial for ED50 determination using an up-down sequential allocation method.

Background

Methods

Results

Conclusions

Trial registration

Publications

Intrathecal dexmedetomidine as an adjuvant to plain ropivacaine for spinal anesthesia during cesarean section: a prospective, double-blinded, randomized trial for ED<sub>50</sub> determination using an up-down sequential allocation method.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Intrathecal dexmedetomidine as an adjuvant to plain ropivacaine for spinal anesthesia during cesarean section: a prospective, double-blinded, randomized trial for ED₅₀ determination using an up-down sequential allocation method.