Dataset Information

A Height-Based Dosing Algorithm of Bupivacaine in Spinal Anesthesia for Decreasing Maternal Hypotension in Cesarean Section Without Prophylactic Fluid Preloading and Vasopressors: A Randomized-Controlled Non-Inferiority Trial.

ABSTRACT:

Background

There is a high incidence of maternal hypotension in spinal anesthesia for cesarean section. The aim of the study is to investigate whether there is a height-based dosing algorithm of bupivacaine that provides adequate anesthesia with less maternal hypotension.

Methods

There were 2 groups of 280 parturients who did not receive prophylactic fluid preloading: Test and Conventional group. In Test group, a height based dosing algorithm was used to confirm the dose of bupivacaine in parturients without prophylactic vasopressors. In the Conventional group, a constant dose of bupivacaine was used. The complications and quality of anesthesia were evaluated.

Results

In the Conventional group, the shorter participants had higher incidence of hypotension, faster sensory block time, and more participants with complete motor block (p = 0.030, 2.957 × 10^-14, and 0.012). In the Test group, the incidence of hypotension, sensory block time, and number of participants with complete motor block did not change with height (p = 0.199, 0.617, and 0.209). The height-based dosing algorithm of bupivacaine decreased the incidence of hypotension (p = 0.004), induced lower sensory block level and less degree of motor block (p = 3.513 × 10^-7 and 5.711 × 10^-11). The quality of analgesia, quality of muscle relaxation, and degree of intraoperative comfort were similar in both groups (p = 0.065, 0.498, and 0.483).

Conclusions

The height influences the dose of bupivacaine in spinal anesthesia; without prophylactic fluid pre-loading and vasopressors, the height-based dosing algorithm of bupivacaine is suitable, and meets the cesarean section' requirement with less maternal hypotension.

Clinical trial registration

www.ClinicalTrials.gov, identifier: NCT03497364.

SUBMITTER: Huang Q

PROVIDER: S-EPMC9226673 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

A Height-Based Dosing Algorithm of Bupivacaine in Spinal Anesthesia for Decreasing Maternal Hypotension in Cesarean Section Without Prophylactic Fluid Preloading and Vasopressors: A Randomized-Controlled Non-Inferiority Trial.

Huang Qiang Q Wen Gengzhi G Hai Chao C Zheng Zihao Z Li Yali Y Huang Zengping Z Huang Bowan B

Frontiers in medicine 20220610

<h4>Background</h4>There is a high incidence of maternal hypotension in spinal anesthesia for cesarean section. The aim of the study is to investigate whether there is a height-based dosing algorithm of bupivacaine that provides adequate anesthesia with less maternal hypotension.<h4>Methods</h4>There were 2 groups of 280 parturients who did not receive prophylactic fluid preloading: Test and Conventional group. In Test group, a height based dosing algorithm was used to confirm the dose of bupiva ...[more]

PMID: 35755061

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Project description:IntroductionEffectively preventing or treating spinal-induced maternal hypotension is considered to be the Holy Grail of obstetric anaesthesia. Prophylactic fluid preloading and vasopressors decrease hypotension but may aggravate heart load, induce fetal acidosis or maternal bradycardia. Using low-dose local anaesthetic decreases hypotension but may cause insufficient anaesthesia. Whether there is a height-based dosing algorithm of local anaesthetic in spinal anaesthesia for caesarean section that can provide sufficient anaesthesia with less hypotension without prophylactic fluid preloading and vasopressors is unclear. This study was designed to investigate a height-based dosing algorithm of bupivacaine in spinal anaesthesia for caesarean section.Methods and analysisThis single-centre, double-blinded, prospective, non-inferiority, randomised controlled trial will include 264 parturients (between 18 and 45 years of age) who are scheduled for caesarean section. All participants will not receive prophylactic fluid preloading. The participants will be randomly divided into two groups: the test group or conventional group. For parturients in the test group, 0.5% isobaric bupivacaine (1.15-1.70 mL) will be injected into the subarachnoid space without prophylactic vasopressors. The bupivacaine dose depends on the height of subjects. For parturients in the conventional group, 0.5% bupivacaine (1.8 mL) will be injected into the subarachnoid space along with prophylactic vasopressors. The primary outcome is the incidence of maternal hypotension. The secondary outcomes include the failure rate of spinal anaesthesia, level of sensory block, degree of motor block, other complications in parturients, time of operation, neonatal outcome and quality of anaesthesia.Ethics and disseminationThis study was approved by the Ethics Committee of Shenzhen People's Hospital of Jinan University (Permit No. SZY-00251, chairperson Xiaofang Yu) on 8 February 2018The study results will be disseminated through peer-reviewed journals, professional societies and meetings.Trial registration numberNCT03497364; Pre-results.

Project description:BackgroundSpinal anesthesia is the standard technique for elective cesarean section, but the incidence of maternal hypotension in this setting is reportedly about 80%, without any prophylactic management. Vasopressors are the most reliable method for counteracting the hypotension induced by spinal anesthesia. However, studies investigating the effects of vasopressors have yielded inconsistent and debatable results. Therefore, we plan to conduct a systematic review and network meta-analysis to identify the most effective vasopressor to prevent maternal hypotension, and to decrease fetal acidosis in women undergoing spinal anesthesia for elective cesarean section.MethodsA systematic and comprehensive search to detect all the randomized controlled studies on vasopressors for the management of maternal hypotension during cesarean section under spinal anesthesia will be performed using information in the databases, MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), and Google Scholar, beginning from their inception to October 2018. We will conduct a network meta-analysis to combine the direct and indirect comparisons of the vasopressors. We will use the surface under the cumulative ranking curve (SUCRA) values and rankograms to present the hierarchy of vasopressors. A comparison-adjusted funnel plot will be used to assess the presence of small-study effects. The quality of the studies included will be assessed using the risk of bias tool. All statistical analyses will be performed using Stata SE version 15.0.Ethics and disseminationThis systematic review and meta-analysis will be published in a peer-reviewed journal. Ethical approval and informed consent are not required, as the study will be a literature review and will not involve direct contact with patients or alterations to patient care.Trial registration numberThe protocol for this review has been registered in the PROSPERO network (registration number: CRD42018111852).

Project description:BackgroundMaternal hypotension is the most frequent complication of spinal anesthesia for cesarean delivery, and intravenous fluid preloading is a preventive measure. We aimed to assess the efficacy of colloids versus crystalloids for preloading to reduce the incidence of spinal anesthesia-induced hypotension and vasopressor requirement in healthy parturients during elective cesarean delivery.MethodsWe searched the Cochrane Library, MEDLINE and EMBASE to identify all studies published to June, 2019, through OVID and PubMed. We included randomized controlled trials, comparing colloid preloading with crystalloid preloading in women having spinal anesthesia for cesarean delivery. Primary outcomes were the incidence of hypotension and vasopressor requirement. Secondary outcomes included nausea and/or vomiting, neonatal Apgar score, neonatal umbilical blood pH. We used standardized mean differences for expressing continuous outcomes and risk ratios for dichotomous outcomes. Random-effect model was performed to estimate the pooled risk ratios and standardized mean differences.ResultsThirty-three randomized controlled trials contributed data for this meta-analysis. Fewer women experienced hypotension in the colloid group compared with the crystalloid group (risk ratio: 0.72, 95% confidence interval: 0.63-0.82; 2566 women, 32 studies; P < .00001). The total ephedrine dose required was significantly lower with colloid preloading (standardized mean difference: -0.37, 95% CI: -0.64 to -0.09; 1472 women, 19 studies; P = .009). Colloid preloading was also associated with fewer phenylephrine requirement compared with crystalloid preloading (standardized mean difference: -0.54, 95% CI: -0.82 to -0.25; 169 women; P = .0002). The incidence of nausea and/or vomiting was significantly reduced with colloid preloading (risk ratio: 0.72, 95% CI: 0.55-0.95; 1601 women, 20 studies; P = .02). However, the incidence of 1-minute Apgar score < 7, umbilical artery pH < 7.2 and umbilical vein pH < 7.2 were not statistically different between groups.ConclusionsColloid preloading is superior to crystalloid preloading in reducing the incidence of hypotension induced by spinal anesthesia and vasopressor requirement in the healthy parturients undergoing elective cesarean delivery.The PROSPERO registration number: CRD42018096402.

Project description:Introduction: In this study, we aimed to evaluate the potential dose-response relationship between prophylactic norepinephrine (NE) infusion rates and the risks of hypotension during cesarean section following spinal anesthesia. Methods: Randomized controlled trials with two or more NE doses for post-spinal hypotension prophylaxis during cesarean section were systematically searched in the MEDLINE, Embase, Web of Science, Cochrane Central Register of Controlled Trials, and US Clinical Trials Registry databases until 31 July 2022. The primary outcome was the relative risk of maternal hypotension with different NE regimens (infusion rates or bolus doses). Secondary outcomes included the relative risks of maternal and fetal adverse events with different NE regimens. Results: Ten studies with 1,144 parturients were included for final analysis using restricted cubic splines and random-effects dose-response meta-analysis models. A significant dose-response relationship existed between NE infusion rates and the relative risks of maternal hypotension. Every 0.01 μg/kg/min increment in the NE infusion rate was associated with a 14% decrease in the incidence of post-spinal hypotension. ED50 and ED95 of NE infusion rates for post-spinal hypotension prophylaxis were estimated to be 0.046 (95% CI from 0.032 to 0.085) and 0.2 (95% CI from 0.14 to 0.37) μg/kg/min, respectively. However, a higher NE infusion rate was associated with a higher incidence of maternal hypertension. Conclusion: An increased NE infusion rate was associated with a decreased incidence of post-spinal hypotension but an increased incidence of hypertension. Therefore, 0.07 μg/kg/min was recommended as the initial NE infusion rate for clinical practice, as it was associated with the lowest risk of physician intervention for unstable hemodynamics after spinal anesthesia for cesarean delivery. Systematic Review Registration: (https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=349934), identifier (CRD42022349934).

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

A Height-Based Dosing Algorithm of Bupivacaine in Spinal Anesthesia for Decreasing Maternal Hypotension in Cesarean Section Without Prophylactic Fluid Preloading and Vasopressors: A Randomized-Controlled Non-Inferiority Trial.

Background

Methods

Results

Conclusions

Clinical trial registration

Publications

A Height-Based Dosing Algorithm of Bupivacaine in Spinal Anesthesia for Decreasing Maternal Hypotension in Cesarean Section Without Prophylactic Fluid Preloading and Vasopressors: A Randomized-Controlled Non-Inferiority Trial.

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