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Randomised trial of intravenous infusion of ephedrine or mephentermine for management of hypotension during spinal anaesthesia for Caesarean section
A. Kansal,1 M. Mohta,2 A. K. Sethi,3 A. Tyagi4 and P. Kumar5
1 Postgraduate student, 2 Reader, 3 Professor and Head of Department, 4 Senior Lecturer, 5 Former Junior Resident, Department of Anaesthesiology and Critical care, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi 110096, India Summary

This study compared the effects of intravenous infusions of ephedrine and mephentermine for maintenance of maternal arterial pressure and neonatal outcome in pregnant women receiving subarachnoid block for lower segment Caesarean section. Sixty patients who developed hypotension following subarachnoid block for Caesarean section were randomly divided into two groups of 30 each to receive an intravenous infusion of ephedrine or mephentermine. Hypotension was dened as a decrease in systolic blood pressure of 20% from the baseline value or an absolute value of <100 mmHg, whichever was higher. The vasopressor infusion was titrated to maintain systolic blood pressure between hypotension and baseline values. Baseline haemodynamic parameters, haemodynamic changes subsequent to the start of vasopressor infusion, duration of hypotension and amount of vasopressor required were statistically similar for both groups. Neonatal APGAR scores and acid-base proles were also comparable. To conclude, mephentermine can be used as safely and effectively as ephedrine for the management of hypotension during spinal anaesthesia in patients undergoing elective Caesarean section.
. ......................................................................................................

Correspondence to: M. Mohta E-mail: medhamohta@hotmail.com Accepted: 13 August 2004

Regional anaesthesia for Caesarean delivery is associated with a high incidence of maternal hypotension [1] and may result in fetal acidaemia due to decreased uteroplacental blood ow [24]. Commonly used methods to prevent or treat such hypotension include preloading with uids [5], avoidance of aortocaval compression [6] and the administration of vasopressor drugs [710]. Various vasopressor drugs have been studied for this purpose, e.g. ephedrine, mephentermine, methoxamine, metaraminol, phenylephrine, angiotensin II, dopamine and dobutamine [710]. Ephedrine is a potent sympathomimetic drug that has both a- and b-adrenergic agonist actions and acts both directly and indirectly at adrenergic nerve endings. Cardiac stimulation is a more prominent action, so that the blood pressure and cardiac output are increased [11]. Ephedrine is the most commonly recommended drug to treat hypotension associated with regional anaesthesia in obstetrics. According to a survey, it is used as the sole
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vasopressor by 95% of consultant obstetric anaesthetists in the UK [12]. Recently, there have been reports indicating worsening fetal acidosis with the use of ephedrine [13], and demonstrating the superiority of other vasopressor drugs such as angiotensin II [9], phenylephrine [8] and metaraminol [10]. Mephentermine is also a mixed sympathomimetic amine that acts both directly and indirectly via an action on a) and b-adrenergic receptors. It has both cardiac and peripheral actions [14]. It has a prominent b-receptor and a weak a-receptor stimulant effect and increases the blood pressure mainly by augmenting the cardiac output [15]. To a lesser degree, a selective constrictive effect on the peripheral vascular bed causing venoconstriction may also contribute to the increase in blood pressure [16]. The change in heart rate is variable, depending on the degree of vagal tone. Mephentermine has been used to treat hypotension by intravenous and intramuscular routes. It is commonly used as intravenous
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Anaesthesia, 2005, 60, pages 2834 A. Kansal et al. Hypotension management during Caesarian section . ....................................................................................................................................................................................................................

boluses of 35 mg as required or an intravenous infusion of 25 mg.min)1. Mephentermine is readily available and is the most commonly used vasopressor in India to treat spinal anaesthesia induced hypotension, but not many workers have studied and compared it with other vasopressors regarding its safety and efcacy. The English literature mentions only one study in pregnant women that compares mephentermine with ephedrine for the management of spinal anaesthesia induced hypotension in obstetric patients [17]. However, even that study does not evaluate the effects of these drugs on fetal metabolic status. The present study compares the effects of ephedrine hydrochloride and mephentermine sulphate, administered intravenously, on maintenance of arterial pressure before delivery of the baby and fetal outcome in pregnant women receiving subarachnoid block (SAB) for lower segment Caesarean section.
Methods

After approval from our institutional ethics committee, the study was conducted on ASA I and II women with term, uncomplicated, singleton pregnancy scheduled for elective Caesarean section under SAB. The protocol was explained to all the patients in detail in their own language and informed consent taken. Prospective power analysis was based on potential differences in umbilical cord blood gases using data from normal deliveries [18]. This showed that a sample size of 22 patients per group would have 90% power at the 5% signicance level to detect a difference in umbilical arterial pH of 0.05 units. Hence, a sample size of 30 patients in each group was considered appropriate for the study. Sixty consecutive patients who developed hypotension after SAB were included. It was necessary to enrol 96 patients to nd 60 patients who developed hypotension during the course of SAB before delivery of the baby. A detailed pre-anaesthetic assessment was done and patients suffering from diabetes, pregnancy-induced hypertension, cardiovascular disease, cerebrovascular diseases, autonomic neuropathy, spinal deformities, other neurological diseases, infections in the lumbar area, coagulation abnormalities, hypovolaemia due to any cause and systolic blood pressure (SBP) < 100 mmHg were excluded from the study. Patients with placental complications (placenta praevia or placental abruption), cord complications (nuchal cord or cord prolapse), fetal malformations and those with a baby birth weight < 2.5 kg or > 4.5 kg were also excluded. Patient height and weight were measured during the pre-anaesthetic visit. Baseline values for maternal SBP and
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heart rate (HR) were recorded as the average of three readings, with the patients lying supine with a standard sized wedge (30 56 10 cm) under the right buttock [19]. Patients were asked to fast overnight and were given oral ranitidine 150 mg the night before. One hour before surgery, ranitidine 50 mg and metoclopramide 10 mg were given intravenously. In the operating room, an intravenous line was established and the patients were preloaded with Ringer lactate solution, 10 ml.kg)1 [20] administered over a period of 1015 min and the infusion rate was reduced to 4 ml.kg)1.h)1 thereafter. Lumbar puncture was performed with strict aseptic precautions by a midline approach using 25 G Quincke spinal needle inserted at the L2L3 or L3L4 vertebral interspace. After establishing a free ow of clear cerebrospinal uid, 2.2 ml of hyperbaric bupivacaine 0.5% was injected in patients with a height > 150 cm, as is the routine practice in our institution. The volume of bupivacaine was decreased to 2 ml if the patients height was 141150 cm and the volume was further decreased by 0.2 ml for every 5 cm decrease in height. The patient was then immediately turned supine and the wedge placed under the right buttock. Oxygen was administered by clear facemask throughout the procedure. The upper level of sensory block was assessed in the midline by pinprick using a sterile 26 G needle. Monitoring included continuous ECG, heart rate, non-invasive blood pressure and pulse oximetry. Heart rate and SBP were noted before giving spinal anaesthesia and every minute after spinal injection until the delivery of the baby. Patients were randomly divided into two groups of 30 each using a sealed envelope technique according to the drug used for maintenance of blood pressure, i.e. Ephedrine group and Mephentermine group. Depending upon the group assigned, ephedrine or mephentermine was used in an infusion containing 5 mg.ml)1 of drug. The vasopressor solutions were prepared by an anaesthetist other than the investigator, and both the investigator and the patient were blinded as to the type of vasopressor used. Hypotension after spinal block was dened as a fall of 20% from the baseline or an absolute value of < 100 mmHg of SBP [21,22]. The higher of these values was taken as the hypotension value. The vasopressor infusion was started when the hypotension value was reached. After an initial bolus of 1 ml (5 mg), the infusion was started at the rate of 0.5 ml.min)1 (2.5 mg.min)1). For every further decrease in SBP by 10% of the hypotension value, the rate of infusion was increased by 0.5 ml.min)1 and titrated accordingly. The infusion rate was adjusted after each 1-min measurement of SBP to maintain it between the hypotension value and baseline, and was stopped if the SBP increased to above the
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A. Kansal et al. Hypotension management during Caesarian section Anaesthesia, 2005, 60, pages 2834 . ....................................................................................................................................................................................................................

baseline value. In the event of the SBP decreasing to the hypotension value after stopping the vasopressor infusion, it was restarted at the rate of 0.5 ml.min)1 and titration resumed in a similar manner to that described above. The total dose of vasopressor used until delivery of baby was noted. The times of skin incision, uterine incision and delivery of baby were recorded. Umbilical arterial and venous blood samples were obtained from a segment of umbilical cord double-clamped before the babys rst breath for immediate blood gas analysis. Apgar scores were recorded at 1 and 5 min after delivery. The study period continued until the delivery of the baby. Any complications observed during spinal anaesthetic technique such as nausea, vomiting or dizziness were also recorded. Inter- and intragroup comparisons of the data obtained were done using repeated measures of ANOVA followed by Tukeys test and unpaired t-test with Bonferroni adjustment wherever applicable. The incidence of complications in the two groups was analysed by using the Chi-squared test. A p-value < 0.05 was taken to be signicant.
Results

Table 2 Hypotension and vasopressor administration. Values are

mean (SD) or median [range].

Ephedrine (n = 30) Maximum decrease in SBP* from baseline; mmHg Maximum decrease in SBP* from baseline % No. of hypotensive episodes Duration of hypotension; min Total amount of vasopressor required; mg Vasopressor required to correct hypotension to hypotension value; mg Vasopressor required to maintain SBP*between hypotension value and baseline; mg *SBP, systolic blood pressure. 31.8 (11.47) 25.7 (8.45) 1 [12] 2.4 (1.38) 19.9 (11.45) 13.6 (6.96) Mephentermine (n = 30) 28.0 (12.79) 22.6 (9.34) 1 [13] 2.3 (1.60) 17.2 (10.38) 12.9 (8.56)

p-value 0.235 0.195 0.145 0.730 0.332 0.727

6.4 (7.16)

4.3 (3.94)

0.176

The patients characteristics are shown in Table 1. The groups were similar with respect to baseline HR, SBP, volume of bupivacaine injected, level of sensory block, calculated hypotension value, onset of hypotension following SAB and uterine incision to delivery time. The maximum fall in SBP from baseline, maximum decrease in SBP as a percentage of baseline, number of hypotensive episodes and duration of hypotension were
Table 1 Patient characteristics. Values are mean (SD) or median

found to be statistically similar in the two groups, as were the amount of vasopressor required for maintenance of blood pressure, the amount needed to correct hypotension and amount required to maintain SBP between the hypotension value and baseline (Table 2). Mean SBP and HR values in the two groups were compared after the start of the vasopressor infusion. The data chosen for analysis and comparison were from the onset of hypotension, each minute until the 12 min time point (Figs 1 and 2), as the number of subjects decreased substantially thereafter and the means became statistically unreliable. No statistical differences were found in the

[range].
150

Ephedrine (n = 30) Age; year Height; cm Weight; kg Period of gestation; weeks Fasting period; h Volume of bupivacaine injected; ml Block height; thoracic dermatone Baseline systolic blood pressure; mmHg Baseline heart rate; beatmin)1 Hypotension value; mmHg Onset of hypotension; min Uterine incision to delivery time; min 26.2 148.1 53.7 38.2 (3.97) (6.58) (9.28) (1.24)

Mephentermine (n = 30)
Systolic Blood Pressure (mmHg)

140 130 120 110 100 90 80 70

Baseline 0 1 2 3 4 5 6 7 8 9 10 11 12

26.0 150.8 61.4 38.0

(3.29) (4.44) (11.53) (0.72)

11.6 (2.28) 2.2 [1.62.2] 6 [28] 122.5 (8.31) 95.1 (13.4) 101.7 (2.78) 5.8 (3.82) 1.7 (0.92)

12.1 (1.61) 2.2 [2.02.2] 6 [38] 121.5 (9.99) 94.8 (13.6) 102.2 (3.48) 5.3 (4.68) 1.6 (0.77)

Vasopressor started

Time from onset of hypotension (min)

Figure 1 Changes in systolic blood pressure from onset of

hypotension in patients given ephedrine (s) or mephentermine (). Values are mean (error bars indicate SD).

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Anaesthesia, 2005, 60, pages 2834 A. Kansal et al. Hypotension management during Caesarian section . ....................................................................................................................................................................................................................
150 140 130 120
Heart Rate (bpm)

Table 4 Side-effects and complications. Values are number (%).

Ephedrine (n = 30) Nausea vomiting Precordial pain RR variability Ventricular ectopics Bradycardia Dizziness Headache Restlessness 5 0 1 1 1 1 0 1 (16.66) (0.00) (3.33) (3.33) (3.33) (3.33) (0.00) (3.33) Mephentermine (n = 30) 2 2 3 1 2 2 1 0 (6.66) (6.66) (10.00) (3.33) (6.66) (6.66) (3.33) (0.00)

p-value 0.212 0.246 0.306 0.754 0.500 0.500 0.500 0.500

110 100 90 80 70 60 50 40 30 20 Baseline 0 1 2 3 4 5 6 7 8 9 10 11 12 Time from onset of hypotension (min)

Figure 2 Changes in heart rate from onset of hypotension in

patients given ephedrine (s) or mephentermine (). Values are mean (error bars indicate SD).
Table 3 Fetal Parameters at birth. Values are mean (SD) or

median [range] or number (%).

Ephedrine (n = 30) Apgar at 1 min Apgar at 5 min Umbilical arterial blood gas pH PO2 PCO2 O2 saturation HCO3 BE Umbilical venous blood gas pH PO2 PCO2 O2 saturation HCO3 BE Umbilical arterial pH < 7.20 8 [69] 9 [810] 7.29 26.10 48.26 41.92 22.22 )5.09 (0.06) (4.51) (14.75) (11.01) (5.33) (4.46) Mephentermine (n = 30) p-value 8 [69] 9 [710] 7.27 26.34 50.97 41.35 22.44 )5.61 (0.08) (5.56) (15.10) (13.84) (5.52) (5.43) 0.180 0.240

The maximum decrease in SBP as a percentage of baseline had a signicant negative linear correlation with umbilical arterial pH for both ephedrine and mephentermine groups (r = 0.42 and 0.57, respectively). The stepwise multiple regression analysis also revealed a signicant association between umbilical arterial pH and the maximum decrease in SBP as a percentage of baseline, but there was no signicant association between umbilical artery pH with other variables such as uterine incision to delivery time, total amount of vasopressor drug used, or duration of hypotension in both the groups.
Discussion

0.280 0.855 0.484 0.859 0.878 0.691 0.845 0.348 0.058 0.999 0.084 0.249 0.353

7.34 (0.06) 36.85 (7.89) 37.15 (9.68) 64.90 (13.20) 19.43 (4.17) )5.49 (3.66) 3 (10%)

7.34 (0.06) 39.85 (15.50) 42.54 (11.77) 64.90 (17.08) 21.69 (5.69) )4.15 (5.16) 5 (16.66%)

SBP and HR values in the two groups during these times. Neonatal Apgar scores after 1 and 5 min and blood gas analysis of umbilical arterial and venous samples were found to be comparable statistically in both groups (Table 3). The incidence of foetal acidosis was also not statistically signicantly different. The incidence of complications such as nausea, vomiting, dizziness, headache, chest pain, restlessness and ECG changes in the form of bradycardia, RR variability and ectopics were similar in both groups (Table 4). One patient in the mephentermine group required intravenous atropine 0.6 mg for bradycardia. No other side-effect required any active intervention.
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Hypotension is an important complication of spinal anaesthesia and prompt effective treatment is considered essential to prevent fetal acidaemia. The results of our study indicate that mephentermine is as effective as ephedrine in maintaining maternal arterial pressure during spinal anaesthesia and both drugs have similar effects on neonatal outcome in terms of umbilical artery pH and Apgar score. Similar results with regards to maternal haemodynamics and neonatal Apgar scores have been reported by Sahu et al. [17], the only study in the literature comparing ephedrine and mephentermine administered as intravenous bolus for the treatment of hypotension associated with spinal anaesthesia during Caesarean section. However, they did not study the effect of these drugs on umbilical artery pH. Thus, ours is the rst study comparing neonatal outcome in terms of umbilical arterial pH following the use of ephedrine and mephentermine. Patients suffering from pregnancy-induced hypertension, cardiovascular disease, cerebrovascular disease, autonomic neuropathy, spinal deformities, other neurological diseases, infections in the lumbar area, coagulation abnormalities and hypovolaemia due to any cause were excluded from the study, as these conditions constitute absolute or relative contraindications for SAB. Any prerenal or renal condition, such as diabetes, pre-eclampsia
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A. Kansal et al. Hypotension management during Caesarian section Anaesthesia, 2005, 60, pages 2834 . ....................................................................................................................................................................................................................

or chronic hypertension, may result in fetal metabolic acidaemia unrelated to hypoxia and was another reason for exclusion. Patients with placental complications such as placenta praevia or abruptio placentae, and cord complications such as nuchal cord or cord prolapse were also excluded from the study, as these conditions have been known to affect umbilical cord blood gas analysis [23]. Patients with baseline SBP < 100 mmHg were also not included in the study, since studies have shown SBP values below this value to be associated with poor fetal outcome [21]. Patients with baby birth weight < 2.5 kg were excluded because of the possibility of intrauterine growth retardation and its impact on fetal umbilical cord blood gas analysis and Apgar scores [23]. Preterm deliveries were not included in the study due to the discrepancy in umbilical cord blood gas analysis and Apgar scores in such patients. Studies have demonstrated that premature delivery does not result in an increased incidence of fetal acidaemia when compared with delivery at term [24]; however, prematurity is associated with lower Apgar scores. Patients with baby birth weight > 4.5 kg were also excluded from the study because of the risk of associated maternal diabetes. Hypotension has been variously dened as a decrease in SBP of 30 mmHg [25], a decrease of 20% below baseline pressure [4,7] or an absolute value of < 100 mmHg [21]. For the purpose of our study, hypotension was dened as a decrease in arterial pressure 20% from baseline SBP or < 100 mmHg, whichever was higher. This was based on the fact that the percentage decrease in placental perfusion is related to the percentage decrease in maternal arterial pressure and not to the absolute decrease in pressure [26]. Moreover, a maternal SBP of < 100 mmHg has been said to be responsible for pathologic foetal bradycardia [21]. Symbolic blood pressure was chosen to dene hypotension, since many investigators believe that spinal sympathectomy primarily affects systolic tension [27]. To correct maternal hypotension, the use of vasopressors has been described by intramuscular injection, intravenous bolus or intravenous infusion. Intravenous infusion of vasopressors is associated with better control of arterial pressure and fewer maternal side-effects compared with intermittent intravenous bolus doses [28,29] or intramuscular administration [30]. Prophylactic administration of ephedrine is associated with a higher incidence of fetal acidaemia [13]. Moreover, studies have reported that with a short period of hypotension of < 2 min, changes in the acid-base status of the neonate remain within normal limits [22]. Therefore, in our study, vasopressors were administered as an intravenous infusion for treatment of hypotension. Blood gas analysis of umbilical arterial and venous samples was performed immediately to avoid changes
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occurring due to delay in analysis [31]. The values of umbilical arterial and venous pH, PO2, PCO2, bicarbonate, base decit and O2 saturation were similar in the two groups. Multiple regression analysis has shown the maximum decrease in SBP in the mother as a percentage of baseline to be the only important factor affecting umbilical arterial pH. Ngan Kee et al. [32] reported a similar relation between umbilical arterial pH and maximum decrease in SBP. The incidence of fetal acidosis, dened as umbilical arterial blood pH < 7.20, was 10% in the ephedrine group and 16.6% in the mephentermine group, and was found to be comparable statistically in the two groups. Several studies have reported a surprisingly high incidence of fetal acidosis that is not accompanied by neonatal depression after spinal anaesthesia for Caesarean section [2,3,10]. Mercier et al. [33] reported a 63% incidence of foetal acidosis with a prophylactic intravenous infusion of ephedrine in parturients receiving spinal anaesthesia during Caesarean section. However, Apgar scores at 1 min and 5 min were never < 7 in their study. Ngan Kee et al. [10] maintained SBP between 90 and 100% of baseline using intravenous infusion of ephedrine in 25 parturients undergoing Caesarean section under SAB and recorded a 39% incidence of fetal acidosis. The higher incidence of fetal acidosis reported in these studies could have been due to the higher doses of ephedrine used. There are no studies in the literature that evaluate fetal acid-base status with concomitant use of mephentermine as a vasopressor in the mother. Neonatal Apgar scores and umbilical arterial pH have been reported by many workers to have no correlation [34]. In our study, one patient in each group had an Apgar score of six at 1 min, though umbilical arterial pH in these neonates was > 7.20. Thus we also could not nd any correlation between these two parameters, proving the unreliability of Apgar for diagnosing fetal acidaemia. In conclusion, maternal hypotension should be aggressively managed to minimise the risk of fetal acidosis, as a denite correlation exists between the maximum decrease in SBP as a percentage of baseline and umbilical arterial pH. Maintenance of SBP between hypotension value and baseline value by carefully titrating the vasopressor infusion results in a satisfactory fetal outcome. Both ephedrine and mephentermine are equally efcacious for the management of maternal hypotension and result in a similar neonatal acid-base status. Our results suggest that mephentermine can be used as safely and effectively as ephedrine for management of hypotension before delivery of the baby during spinal anaesthesia in patients undergoing elective Caesarean section.
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