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Height-based dosing algorithm of bupivacaine in spinal anaesthesia for decreasing maternal hypotension in caesarean section without prophylactic fluid preloading and vasopressors: study protocol for a randomised controlled non-inferiority trial.

ABSTRACT: INTRODUCTION:Effectively 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 ANALYSIS:This 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 DISSEMINATION:This 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 NUMBER:NCT03497364; Pre-results.

SUBMITTER: Huang B

PROVIDER: S-EPMC6530369 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Height-based dosing algorithm of bupivacaine in spinal anaesthesia for decreasing maternal hypotension in caesarean section without prophylactic fluid preloading and vasopressors: study protocol for a randomised controlled non-inferiority trial.

Huang Bowan B Huang Qiang Q Hai Chao C Zheng Zihao Z Li Yali Y Zhang Zhongjun Z

BMJ open 20190516 5

<h4>Introduction</h4>Effectively 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 s ...[more]

PMID: 31101694

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Project description:Background: Obesity, abdominal surgery, and intrathecal opioids are all factors associated with a risk for respiratory compromise. The aim of this explorative trial was to study the apnoea/hypopnea index 1st postoperative night in obese mothers having had caesarean section (CS) in spinal anaesthesia with a combination of bupivacaine/morphine and fentanyl. Methods: Consecutive obese (BMI >30 kg/m 2) mothers, ≥18 years, scheduled for CS with bupivacaine/morphine/fentanyl spinal anaesthesia were monitored with a portable polygraphy device Embletta /NOX on 1 st postoperative night. The apnoea/hypopnea index (AHI) was identified by clinical algorithm and assessed in accordance to general guidelines; number of apnoea/hypopnea episodes per hour: <5 "normal", ≥5 and <15 mild sleep apnoea, ≥15 and <30 moderate sleep apnoea, ≥ 30 severe sleep apnoea. Oxygen desaturation events were in similar manner calculated per hour as oxygen desaturation index (ODI). Results: Forty mothers were invited to participate: 27 consented, 23 were included, but polysomnography registration failed in 3. Among the 20 mothers studied: 11 had an AHI <5 ( normal), 7 mothers had AHI ≥5 but <15 ( mild OSAS) and 2 mothers had AHI ≥15 ( moderate OSA), none had an AHI ≥ 30. The ODI was on average 4.4, and eight patients had an ODI >5. Mothers with a high AHI (15.3 and 18.2) did not show high ODI. Mean saturation was 94% (91-96%), and four mothers had mean SpO 2 90-94%, none had a mean SpO2 <90%. Conclusion: Respiratory polygraphy 1 st night after caesarean section in spinal anaesthesia with morphine in moderately obese mothers showed AHIs that in sleep medicine terms are considered normal, mild and moderate. Obstructive events and episodes of desaturation were commonly not synchronised. Further studies looking at preoperative screening for sleep apnoea in obese mothers are warranted but early postop respiratory polygraphy recording is cumbersome and provided sparse important information.

Project description:BackgroundIn Germany, hypotension induced by spinal anaesthesia is commonly treated with a combination of cafedrine hydrochloride (C, 200 mg) and theodrenaline hydrochloride (T, 10 mg) in 2 ml. We compared the effectiveness of C/T with ephedrine.ObjectivesThe primary objectives were to assess the speed of onset and the ability to restore blood pressure without an increase in heart rate. Secondary objectives were to evaluate maternal/foetal outcomes and the number of required additional boluses or other additional measures.DesignHYPOTENS was a national, multicentre, prospective, open-label, two-armed, noninterventional study comparing C/T with ephedrine in two prospectively defined cohorts. This study relates to the cohort of patients receiving spinal anaesthesia for caesarean section.SettingGerman hospitals using either C/T or ephedrine in their routine clinical practice.PatientsWomen aged at least 18 years receiving spinal anaesthesia for caesarean section.InterventionsBolus administration of C/T or ephedrine at the discretion of the attending anaesthesiologist.Main outcome measuresEndpoints within 15 min after initial administration of C/T or ephedrine were area under the curve between the observed SBP and the minimum target SBP; and incidence of newly occurring heart rate of at least 100 beats min-1.ResultsAlthough effective blood pressure stabilisation was achieved with both treatments, this effect was faster and more pronounced with C/T (P < 0.0001). The incidence of tachycardia and changes in heart rate were higher with ephedrine (P < 0.01). Fewer additional boluses (P < 0.01) were required with C/T. Although favourable neonatal outcomes were reported in both groups, base deficit and lactate values were greater with ephedrine (P < 0.01). Physician satisfaction was higher with C/T.ConclusionsAfter C/T, tachycardia was not a problem, providing an advantage over ephedrine. Fewer additional boluses were required with C/T, suggesting greater effectiveness. An increased base deficit with ephedrine suggests reduced oxygen supply or increased demands in foetal circulation.Trials registrationClinicaltrials.gov: NCT02893241, German Clinical Trials Register: DRKS00010740.

Project description:Bupivacaine is the most commonly used local anaesthetic for spinal anaesthesia (SA). There are two forms of commercially available bupivacaine; isobaric bupivacaine (IB): a formulation with a specific gravity or density equal to cerebrospinal fluid, and hyperbaric bupivacaine (HB): a formulation with density heavier than cerebrospinal fluid. The difference in densities of the two available preparations is believed to affect the diffusion pattern that determines the effectiveness, spread and side-effect profile of bupivacaine. This systematic review will summarise the best available evidence regarding the effectiveness and safety on the use of HB compared with IB, when used to provide SA for surgery. Primarily, we will analyse the need for conversion to general anaesthesia. As secondary outcomes, we will compare the incidence of hypotension, incidence of nausea/vomiting, the onset time and duration of anaesthesia.We will search key electronic databases using search strategy (1) injections, spinal OR intrathecal OR subarachnoid; (2) bupivacaine OR levobupivacaine; (3) hypobaric OR isobaric OR plain; (4) baricity. We will search MEDLINE, EMBASE and Cochrane databases, from their inception for randomised controlled trials, with no restrictions on language. Caesarean section surgery will be excluded. 2 reviewers will independently extract the data using a standardised form. Extracted items will include study characteristics, risk of bias domains, as per modified Cochrane risk of bias, participant disposition and study outcomes. We will conduct a meta-analysis for variables that can be compared across the studies. We will evaluate clinical heterogeneity by qualitatively appraising differences in study characteristics in participants, interventions and the outcomes assessed. We will report our findings as relative risks (dichotomous), and weighted mean differences (continuous) for individual outcomes, along with their 95% CIs.We plan to submit, and will publish, our findings in a peer-reviewed scientific journal, and present our results at national and international meetings.CRD42015017672.

Project description:BackgroundProphylactic antibiotics reduce infectious morbidity from caesarean section. The timing of their administration, however, is a matter of controversy.ObjectivesTo examine maternal and neonatal infectious morbidity in women receiving preoperative prophylaxis compared with those receiving intraoperative administration.Search strategyMedline, Embase, Current Controlled Trials and Cochrane Central were searched from their inception dates to December 2011.Selection criteriaRandomised controlled trials of a single dose of any antibiotic comparing preoperative with intraoperative administration were selected.Data collection and analysisTrial characteristics, outcomes and quality measures, based on the Cochrane tool for risk of bias, were independently extracted. The random effect model of DerSimonian and Laird to estimate relative risks (RRs) for maternal and neonatal outcomes was used.Main resultsSix trials met the inclusion criteria, reporting on 2313 women and 2345 newborns. Preoperative administration was associated with a significant 41% reduction in the rate of endometritis compared with intraoperative administration (RR 0.59; 95% confidence interval [95% CI] 0.37-0.94; I2 0%). In the preoperative group, there were nonsignificant reductions in the rates of wound infection (RR 0.71; 95% CI 0.44-1.14; I2 0%), maternal febrile morbidity (RR 0.94; 95% CI 0.46-1.95; I2 0%), neonatal sepsis (RR 0.81; 95% CI 0.47-1.41; I2 0%), neonatal septic work-up (RR 0.93; 95% CI 0.71-1.21; I2 0%) and neonatal intensive-care unit admission (RR 0.92; 95% CI 0.65-1.28; I2 0%). There were nonsignificant increases in the rates of maternal pyelonephritis (RR 1.09; 95% CI 0.49-2.43; I2 0%) and neonatal pneumonia (RR 3.36; 95% CI 0.55-20.47; I2 0%).ConclusionsCompared with intraoperative administration, preoperative antibiotics significantly reduce the rate of endometritis. The lack of neonatal adverse effects should be cautiously interpreted given the limited power of the trials to detect such effects.

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.

Dataset Information

Height-based dosing algorithm of bupivacaine in spinal anaesthesia for decreasing maternal hypotension in caesarean section without prophylactic fluid preloading and vasopressors: study protocol for a randomised controlled non-inferiority trial.

Publications

Height-based dosing algorithm of bupivacaine in spinal anaesthesia for decreasing maternal hypotension in caesarean section without prophylactic fluid preloading and vasopressors: study protocol for a randomised controlled non-inferiority trial.

Similar Datasets

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