Project description:ObjectivesThis study aimed to determine if low dose intravenous ketamine is effective in reducing opioid use and pain after non-elective caesarean delivery.DesignProspective, randomised, double-blind.SettingTertiary hospital, Bisheshwar Prasad Koirala Institute of Health Sciences, Dharan, Nepal PARTICIPANTS: 80 patients undergoing non-elective caesarean section with spinal anaesthesia.InterventionsPatients were allocated in 1:1 ratio to receive either intravenous ketamine 0.25 mg/kg or normal saline before the skin incision.Primary and secondary outcome measuresThe primary outcome was the total amount of morphine equivalents needed up to postoperative 24 hours. Secondary outcome measures were postoperative pain scores, time to the first perception of pain, maternal adverse effects (nausea, vomiting, hypotension, shivering, diplopia, nystagmus, hallucination) and neonatal Apgar score at 1 and 5 min, neonatal respiratory depression and neonatal intensive-care referral.ResultsThe median (range) cumulative morphine consumption during the first 24 hours of surgery was 0 (0-4.67) mg in ketamine group and 1 (0-6) mg in saline group (p=0.003). The median (range) time to the first perception of pain was 6 (1-12) hours and 2 (0.5-6) hours in ketamine and saline group, respectively (p<0.001). A significant reduction in postoperative pain scores was observed only at 2 hours and 6 hours in the ketamine group compared with placebo group (p<0.05). Maternal adverse effects and neonatal outcomes were comparable between the two groups.ConclusionsIntravenous administration of low dose ketamine before surgical incision significantly reduced the opioid requirement in the first 24 hours in patients undergoing non-elective caesarean delivery.Trial registration numberNCT03450499.
Project description:Background and aimsAlthough spinal anaesthesia (SA) is nowadays the preferred anaesthesia technique for caesarean section (CS), it is associated with considerable haemodynamic effects, such as maternal hypotension. This study aimed to evaluate a wide range of variables (related to parturient and anaesthesia techniques) associated with the incidence of different degrees of SA-induced hypotension during elective CS.MethodsThis prospective study was conducted on 511 mother-infant pairs, in which the mother underwent elective CS under SA. The data were collected through preset proforma containing three parts related to the parturient, anaesthetic techniques and a table for recording maternal blood pressure. It was hypothesized that some maternal (such as age) and anaesthesia-related risk factors (such as block height) were associated with occurance of SA-induced hypotension during elective CS.ResultsThe incidence of mild, moderate and severe hypotension was 20%, 35% and 40%, respectively. Eventually, ten risk factors were found to be associated with hypotension, including age >35 years, body mass index ≥25 kg/m2, 11-20 kg weight gain, gravidity ≥4, history of hypotension, baseline systolic blood pressure (SBP) <120 mmHg and baseline heart rate >100 beats/min in maternal modelling, fluid preloading ≥1000 ml, adding sufentanil to bupivacaine and sensory block height >T4in anaesthesia-related modelling (P < 0.05).ConclusionAge, body mass index, weight gain, gravidity, history of hypotension, baseline SBP and heart rate, fluid preloading, adding sufentanil to bupivacaine and sensory block hieght were the main risk factors identified in the study for SA-induced hypotension during CS.
Project description:ObjectivesWe have previously established a method to measure transfer of nutrients between mother, placenta and fetus in vivo. The method includes measurements of maternal and fetal blood flow by Doppler ultrasound prior to spinal anaesthesia. Spinal anaesthesia affects maternal blood pressure and cardiac output. We aimed to determine the effect of spinal anaesthesia in mothers undergoing an elective caesarean section on blood pressure, heart rate and cardiac output, and whether cardiac output levels were comparable before induction of spinal anaesthesia and before delivery.DesignProspective cohort study.SettingTertiary hospital in Norway.Participants76 healthy women with uneventful pregnancies undergoing an elective caesarean section.InterventionsWe induced spinal anaesthesia with a standard prevention of hypotension including intravenous fluid coloading and phenylephrine infusion.Primary and secondary outcome measuresPrimary outcome measure was maternal cardiac output, and secondary outcome measures were invasive systolic blood pressure and heart rate. We measured heart rate and blood pressure by continuous invasive monitoring with a cannula in the radial artery. Cardiac output was estimated based on continuous arterial waveform. We compared maternal parameters 30 s before induction of spinal anaesthesia to 30 s before delivery.ResultsMedian age at delivery was 34.5 (range 21-43) years and 17 of 76 women were nulliparous. The most prevalent indications were previous caesarean section and maternal request. Among 76 included women, 71 had sufficient data for analysis of endpoints. Median cardiac output was 6.51 (IQR (5.56-7.54) L/min before spinal anaesthesia and 6.40 (5.83-7.56) L/min before delivery (p=0.40)). Median invasive systolic blood pressure increased from 128.5 (120.1-142.7) mm Hg to 134.1 (124.0-146.6) mm Hg (p=0.014), and mean heart rate decreased from 86.0 (SD 13.9) to 75.2 (14.2) (p<0.001).ConclusionsMaternal cardiac output at the time of caesarean delivery is comparable to levels before induction of spinal anaesthesia.Trial registration numberNCT00977769.
Project description:IntroductionIn general, caesarean sections are performed under spinal anaesthesia. Hypotension after spinal anaesthesia adversely affects both the mother and fetus. Although several studies have used pulse oximetry-derived indices, such as pulse perfusion index (PI) and Pleth variability index (PVI), to predict hypotension after spinal anaesthesia, the predictive ability of the PI and PVI remain controversial.Methods and analysisWe prepared this protocol following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. We will conduct searches of MEDLINE, Embase, Web of Science, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Clinicaltrial.gov, European Union Clinical Trials Register (EU-CTR), WHO International Clinical Trials Registry Platform (ICTRP) and University Hospital Medical Information Network Clinical Trials Registry (UMIN) from inception until 8 October 2022. We will include retrospective and prospective observational studies and randomised controlled trials that evaluated the predictive ability of PI and PVI for hypotension after spinal anaesthesia for caesarean section, published in any language. We will exclude case reports, case series and animal studies. Two authors will independently scan and select eligible studies and perform data extraction and assessment of risk of bias. We will estimate predictive ability of PI and PVI as indices of hypotension after spinal anaesthesia for caesarean section using the Reitsma-type bivariate random-effects synthesis model and the hierarchical summary receiver operating characteristic curve. We will assess the quality of evidence using the Grading of Recommendation Assessment, Development and Evaluation approach.Ethics and disseminationEthics approval is not required as the systematic review will use existing published data. The results will be submitted for publication in a peer-reviewed journal.Prospero registration numberCRD42022362596.
Project description:ObjectiveThe main objective of this study was to assess the impact of phenylephrine and cafedrine/theodrenaline on the mother and newborn after spinal anaesthesia for caesarean section.SettingUniversity teaching hospital.DesignA single-centre retrospective data cohort study.PatientsAll obstetric patients who were scheduled for caesarean section in a 2-year period.InterventionsAdministration of either intravenous phenylephrine prophylactically or cafedrine/theodrenaline (Akrinor) reactively to maintain blood pressure after spinal anaesthesia.Main outcome measureMaternal hypotension, heart rate during caesarean section and after admission to IMC, fetal arterial cord pH and base excess levels, maternal volume resuscitation and the use of rescue medication.Results852 data sets could be included: n=440 Akrinor, n=412 in the phenylephrine cohort. During caesarean section blood pressure was slightly higher in the phenylephrine group compared with the Akrinor group, while hypotension <100 mm Hg systolic blood pressure (SBP) occurred significantly more often during arrival at the IMC after surgery when phenylephrine was used. Heart rate was lower and rescue medication was significantly more frequently given in the phenylephrine cohort. Irrespective of the medication used, women with baseline levels of <120 mm Hg SBP had a high risk to develop hypotension <100 mm Hg after spinal anaesthesia for caesarean section. While there was no statistical difference in mean umbilical arterial pH levels, the incidence of acidosis, defined as pH <7.2, was significantly higher with phenylephrine.ConclusionPhenylephrine was not superior to Akrinor to treat spinal anaesthesia-induced maternal hypotension during caesarean section.Trial registration numberDRKS00025795.
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:Background: Cesarean delivery is performed under spinal anesthesia, and vasodilation is the main cause for a drop in blood pressure. The compression of the aorta and inferior vena cava by the gravid uterus is of additional clinical importance. Hypotension may occur during cesarean delivery even if prophylactic infusion of phenylephrine is practiced. We have tested if a 3 minute supine observation, can identify a subset of women with decreasing systolic arterial pressure (SAP) under spinal anesthesia. Methods: We performed a prospective observational study at Oslo University Hospital on healthy pregnant women for planned cesarean delivery. Continuous measurements of calibrated invasive SAP and estimated cardiac output were recorded for 76 women in a 3 minutes measurement with the woman in the left lateral position, followed by supine position for 3 minutes. Using functional data clustering, principal component analysis and curve smoothing, to filter way noise and reduce the dimensionality of the signal, we clustered the women into separate SAP groups. Results: We identified two significantly different groups of women during supine position; one characterized by initial drop in SAP, the other showed initial increase. After spinal anesthesia, the mean SAP curve of the women in the first group showed a drop in blood pressure, which was more rapid than for the other women. A minor difference in cardiac output was observed between the two groups of women with the mean cardiac output curve for the first group being higher. Conclusions: This work indicates that supine position affect clinically relevant cardiovascular measurements in pregnant women. A simple test may identify patients with increased risk of spinal anesthesia induced hypotension.
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 anaesthesia is frequently used in surgical procedures involving the lower abdomen and extremities, however, the occurrence of hypotension remains a common and clinically important adverse effect. Unilateral spinal anaesthesia seems to be a promising approach to minimise this complication but the effectiveness of this remains controversial.ObjectiveA meta-analysis was undertaken to evaluate the superiority of unilateral spinal anaesthesia over bilateral spinal anaesthesia with regard to the incidence of hypotension and other complications.DesignSystematic reviews and meta-analysis of randomised controlled trials (RCTs).Date sourcesPUBMED, Embase, Web of Science and Cochrane Central Register of Controlled Trials databases were searched from their inception to 5 March 2024.Eligibility criteriaRandomised controlled trials (RCTs) comparing unilateral spinal anaesthesia with bilateral spinal anaesthesia were eligible for inclusion. Observational studies, case reports, case series, and studies not conducted in humans were excluded. The incidence of hypotension, vasopressor requirement, and other complications were compared. Heterogeneity was assessed by subgroup analyses and sensitivity analysis.ResultsTwenty-one trials involving 1358 patients undergoing unilateral lower extremity surgery or lower abdominal surgery were included in the meta-analysis. Hyperbaric solutions were used in most trials. The Mantel-Haenszel random-effect model was used for the analysis of binary endpoints, reported as relative risk (RR) with a 95% confidence interval (CI). The incidence of hypotension was significantly lower in the unilateral spinal anaesthesia group compared with the bilateral spinal anaesthesia (RR 0.38, 95% CI 0.27 to 0.55; P < 0.001; I2 = 38%). Subgroup analysis shows that the occurrence of hypotension was significantly lower in the unilateral subgroup, regardless of dosage, surgical site, adjuvants to the local anaesthetics, and different definitions of hypotension.ConclusionsUnilateral spinal anaesthesia is associated with a significant reduction in the occurrence of hypotension, despite variations in the definition of hypotension, adjuvants, and site of surgery. These results favour the use of lateral spinal anaesthesia in patients undergoing unilateral lower abdominal or lower limb surgery. However, the GRADE assessment of the quality of evidence was 'low' due to the high risk of bias and heterogeneity. All the results should be treated with caution.