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Comments on “effective dose 50% (ED50) and effective dose 95% (ED95) of intrathecal bupivacaine in morbidly obese patients undergoing cesarean delivery”
Comentario sobre “dosis efectiva 50% (DE50) y dosis efectiva 95% (DE95) de bupivacaína intratecal en pacientes obesas mórbidas en cesárea”
Javier Bastidas, Eduardo Kattan, Hector J. Lacassie
Corresponding author
lacassie@med.puc.cl

Corresponding author at: Marcoleta 367, 3er piso, Departamento de Anestesiología, Hospital Clínico Universidad Católica, Santiago, Chile.
Division of Anesthesiology, Faculty of Medicine, Pontificia Universidad Católica de Chile, Chile
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">This work presents a critical analysis of the article by Carvalho et al&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">1</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">A decreased dose of local anesthetics is recommended when administering subarachnoid anesthesia in a caesarian section for obese patients&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">2</span></a> Magnetic resonance imaging studies have shown a decrease in the volume of cerebrospinal fluid in this population<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">3</span></a> due to the distension of the epidural veins and the pressure exerted on the dural sac by the increase in soft tissues in the epidural space&#44; which makes the effects of local neuraxial anesthetics unpredictable&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">1</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">While it has been demonstrated that no relationship exists between the height of spinal anesthesia block and body mass index &#40;BMI&#41; for cesarian section&#44;<a class="elsevierStyleCrossRefs" href="#bib0065"><span class="elsevierStyleSup">4&#44;5</span></a> these studies do not examine the morbidly obese in particular&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Objective of the study</span><p id="par0020" class="elsevierStylePara elsevierViewall">To determine the effective dose 50&#37; &#40;ED50&#41; and the effective dose 95&#37; &#40;ED95&#41; of intrathecal bupivacaine associated with opioids in the cesarean section of morbidly obese patients&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Study design</span><p id="par0025" class="elsevierStylePara elsevierViewall">A prospective&#44; randomized&#44; unicentric and double-blind study was designed&#46; Previous authorization from the Ethics committee was obtained and 42 morbidly obese pregnant women were recruited &#40;body mass index &#40;BMI&#41;<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>40 &#40;kg<span class="elsevierStyleHsp" style=""></span>m<span class="elsevierStyleSup">&#8722;2</span>&#41;&#41; who were undergoing a single birth&#44; past 37 weeks of gestation and scheduled for an elective cesarean section&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">The patients were randomly assigned to seven dose groups of the hyperbaric bupivacaine 0&#46;75&#37;&#58; 5&#44; 6&#44; 7&#44; 8&#44; 9&#44; 10 and 11<span class="elsevierStyleHsp" style=""></span>mg associated with a fixed dose of fentanyl 10<span class="elsevierStyleHsp" style=""></span>&#956;g &#40;in 0&#46;2<span class="elsevierStyleHsp" style=""></span>ml&#41; and morphine 200<span class="elsevierStyleHsp" style=""></span>&#956;g &#40;0&#46;4<span class="elsevierStyleHsp" style=""></span>ml&#41; administered intrathecally&#46; The spinal&#8211;epidural anesthetic technique was used&#46; Each group included at least 5 patients&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">The primary outcome was the success or failure of the &#8220;induction component&#8221;&#44; defined as sensory blockade at a T6 level or higher 10<span class="elsevierStyleHsp" style=""></span>min after intrathecal anesthesia was administered&#59; and the &#8220;operation component&#8221;&#44; defined as an anesthetic blockade that did not require analgesic supplementation&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">The secondary outcomes were blood pressure&#44; dose of phenylephrine used in hemodynamic management&#44; intraoperative pain&#44; incidence of nausea&#47;vomiting&#44; maternal satisfaction and time lapsed from the end of surgery until transfer to recovery&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Results</span><p id="par0045" class="elsevierStylePara elsevierViewall">All 42 patients enrolled and randomly assigned completed the study and are included in the analysis&#46; All groups were composed of 6 patients except the 8 and 11<span class="elsevierStyleHsp" style=""></span>mg groups&#44; which were made up of 5 and 7 patients respectively&#46; The demographic and obstetric characteristics were similar among all groups&#44; as well as the surgical duration with an average of 61<span class="elsevierStyleHsp" style=""></span>min &#40;CI 95&#37;&#58; 56&#8211;75<span class="elsevierStyleHsp" style=""></span>min&#41;&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">The ED50 and ED95 &#40;CI95&#37;&#41; were 9&#46;8<span class="elsevierStyleHsp" style=""></span>mg &#40;8&#46;6&#8211;11&#46;0&#41; and 15<span class="elsevierStyleHsp" style=""></span>mg &#40;10&#46;0&#8211;20&#46;0&#41; respectively for the &#8220;operation component&#8221;&#46; The &#8220;induction component&#8221; could not be measured due to its initial success and low failure rate&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">The highest failure rate in the &#8220;operation component&#8221; occurred with small doses with an average failure time of 47<span class="elsevierStyleHsp" style=""></span>min &#40;IC 95&#37;&#58; 20&#8211;62<span class="elsevierStyleHsp" style=""></span>min&#41;&#46; The time required to reach a T6 sensory blockade was 8<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>2<span class="elsevierStyleHsp" style=""></span>min&#44; regardless of the dose used&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">There were no differences in pain levels among different groups at the time of surgical incision&#44; uterine exteriorization&#44; fetal extraction and closure&#46; There was an indirect correlation between the dose of bupivacaine administered and the pain in uterine exteriorization &#40;<span class="elsevierStyleItalic">R</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#8722;0&#46;44&#44; <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;016&#41;&#46; All groups achieved a 100&#37; patient satisfaction rate&#46; The period of recovery was 74<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>20<span class="elsevierStyleHsp" style=""></span>min with no variation among groups&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Reviewers&#8217; commentary</span><p id="par0065" class="elsevierStylePara elsevierViewall">A prospective&#44; unicentric&#44; randomized study blinded to both patients and physicians was conducted&#46; The initial demographic variables were similar&#46; It was not interrupted prematurely and the protocol was completed in 100&#37; of patients&#46; It is worth noting that there is no mention of conflicts of interest&#44; funding sources&#44; or whether the outcome assessor was blinded&#46; It is also worth highlighting that the study did not use a &#8220;normal weight&#8221; control group&#44; but rather&#44; figures reported by Ginosar et al&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">6</span></a> This work was also not originally intended for comparison with non-obese patients &#40;Brendan Carvalho&#44; Cali&#44; Colombia&#44; personal communication&#44; June 2015&#41;&#46; These points carry a higher risk of bias for the study&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">Another weakness of the study is the small sample size&#44; which had adequate statistical power to fulfill the main objective&#46; However&#44; it is not sufficient in finding significant differences to fulfill the secondary objectives&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">This is the first study that calculates ED50 and ED95 of spinal anesthesia for use in morbidly obese patients in cesarean delivery&#46; The logistical regression employed to determine ED50 and ED95 has been amplified using medical literature&#46; However&#44; through this method&#44; ED50 is obtained with higher precision than ED95&#44; since it is extrapolated from the plateau located in the top portion of the curve&#46; This is why the ED95 obtained is 15<span class="elsevierStyleHsp" style=""></span>mg&#44; higher than the group studied with the highest dose &#40;11<span class="elsevierStyleHsp" style=""></span>mg&#41;&#46; It is important to note that the 15<span class="elsevierStyleHsp" style=""></span>mg dose of bupivacaine has not been tested&#44; so its use is not recommended&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">The authors state that the ED50 and ED95 values are similar to those of normal weight patients&#46; However&#44; a control group was not used to support this statement and is only based on a previous study&#44; which could lead to further bias&#46; Even though it was conducted by the same group of researchers with a similar methodology&#44; equal results cannot be concluded&#46; However&#44; these results are concordant with previous research which has estimated the intrathecal dose of bupivacaine in cesarean delivery to be similar between obese and non-obese patients&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">7</span></a></p><p id="par0085" class="elsevierStylePara elsevierViewall">The highest failure rate was reported when using low doses of local anesthesia&#44; which is concordant with the meta-analysis conducted by Arzola et al&#46;&#44; who determined that using doses lower than 8<span class="elsevierStyleHsp" style=""></span>mg of intrathecal bupivacaine increases the risk of intraoperative pain by 3&#46;75 times &#40;CI 95&#37; 2&#46;38&#8211;5&#46;92&#41; along with an increased risk of nausea&#44; whereas converting to general anesthesia reduces the necessary number to cause harm to only 4 patients &#40;CI 95&#37;&#58; 2&#8211;7&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">8</span></a> The potential switch to general anesthesia is especially important since the management of the obese patient&#39;s airway presents a greater challenge&#46; As a consequence&#44; we do not recommend decreasing the dose in morbidly obese patients unless the anesthesia is reinforced by an epidural catheter&#46; Lastly&#44; it is always necessary to consider the experience of the surgical team with regards to technique and duration of the procedure&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">As for the secondary outcomes&#44; duration times for surgery and the period of recovery were similar among groups&#59; this finding is repeated in measuring the time needed to reach a T6 sensory level&#46; There were no differences in the pain level among groups and in the moment of surgical incision&#44; uterine exteriorization&#44; fetal extraction and closure&#46; However&#44; the study does not have sufficient statistical power to determine differences in these outcomes&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">To complement these findings&#44; a recent study has demonstrated a higher incidence of high spinal block in super obese patients &#40;CMI above 50<span class="elsevierStyleHsp" style=""></span>kg<span class="elsevierStyleHsp" style=""></span>m<span class="elsevierStyleSup">&#8722;2</span>&#41;&#44; with no such incidence in lower weight ranges&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">9</span></a> This demonstrates that not all obese patients should receive the same treatment&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">This study provides us a guide for administering spinal anesthesia in the cesarean delivery of morbidly obese patients&#46; If we decide to decrease the dose of local anesthesia compared to that of non-obese patients&#44; this decision must be backed by a technique that allows flexibility in the duration of anesthesia&#44; such as an epidural catheter&#46; Decreasing the dose only increases the risk of failure of the spinal anesthesia and carries a subsequent risk of having to switch to general anesthesia in a patient with potentially difficult airways&#46; The ED95 values &#40;15<span class="elsevierStyleHsp" style=""></span>mg&#41; can be interpreted as a mathematical extrapolation&#44; and as such are not clinically reasonable or recommended&#46; Therefore&#44; in patients with unusual anthropometry&#44; it is perfectly reasonable to use a technique that offers flexibility in anesthetic management and allows for a titrated dose&#44; such as the combined spinal&#8211;epidural technique&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Funding</span><p id="par0115" class="elsevierStylePara elsevierViewall">The authors did not receive sponsorship to carry out this article&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Conflicts of interest</span><p id="par0120" class="elsevierStylePara elsevierViewall">The authors have no conflicts of interest to declare&#46;</p></span></span>"
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es en pt

¿Es usted profesional sanitario apto para prescribir o dispensar medicamentos?

Are you a health professional able to prescribe or dispense drugs?

Você é um profissional de saúde habilitado a prescrever ou dispensar medicamentos