The spinal anesthesia and combined spinal epidural anesthesia versus general anesthesia for cesarean section in severe preeclampsia: a randomized controlled trial study Текст научной статьи по специальности «Клиническая медицина»

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THE SPINAL ANESTHESIA AND COMBINED SPINAL EPIDURAL ANESTHESIA VERSUS GENERAL ANESTHESIA FOR CESAREAN SECTION IN SEVERE PREECLAMPSIA: A RANDOMIZED CONTROLLED TRIAL STUDY

Nguyen Duc Lam

Hanoi Medical University Vu Van Du

National Hospital of Obstetric and Gynecology

ABSTRACT

This study aim to evaluate the analgesia efficacy and the maternal/fetal effects of three anesthetic methods used randomly in women with severe preeclampsia who required cesarean delivery: spinal anesthesia (SA), combined spinal epidural (CSE) anesthesia versus general anesthesia (GA). Material and methods: A RCT study on 180 parturients with severe preeclampsia, who were to be delivered by cesarean and were randomized to general, epidural, or combined spinal-epidural anesthesia. Results: Spinal anesthesia, CSE have good per-operative anesthesia, good postoperative analgesia (good 95% in spinal anesthesia, 100% in CSE; VAS < 4); good hemodynamic stability (hypotension 21,67% in spinal anesthesia; 11,67% in CSE) with minor side effects, no depression of the newborn (Apgar 1' score is 8,4 ± 0,7 in spinal anesthesia, 8,5 ± 0,8 in CSE and 6,7 ± 1,9 in GA). Conclusion: Spinal anesthesia or CSE is a safe choice for caesarean delivery when compared to general anesthesia in severe preeclampsia. Spinal anesthesia is safe and provides better maternal outcome and has fewer intra operative and postoperative complications: good per-operativeanesthesia, good postoperative analgesia, stable hemodynamics, minor side effects and no depression of the newborn.

Keywords: preeclampsia, cesarean section, spinal anesthesia, general anesthesia, combined spinal epidural anesthesia.

1. Introduction

Pre-eclampsia is a complex syndrome of human pregnancy, characterized by hypertension after 20 weeks gestation and proteinuria. Pre-eclampsia is classified as severe if blood pressure (BP) is >160 mmHg systolic and/or >110 mmHg diastolic; or any one of following is present: cerebral or visual disturbances, proteinuria is > 3.5 g/l, thrombocytopenia, impaired liver function, impaired kidney function. Preeclampsia appear the third trimester term of pregnancy and can lead to serious complications for maternal, fetal, or neonatal health. Studies have shown that adequate therapy for a preterm severe preeclampsia is a delivery by cesarean during expectant management [1], [2], [3]. Anesthesia for a safe cesarean delivery is still an on-going challenge for obstetrical anesthesiologist. In the others days, spinal anesthesia were not recommended for se-

vere preeclampsia women due to a possible post-operative hypotension complication which decreases utero-placental blood flow.

Recent studies shown evidence supporting spinal anesthesia for severe preeclampsia women, with no significant differences between preeclampsia women underwent either SA or Epidural anesthesia. Combined spinal epidural (CSE) is well established with better maternal outcomes because it can associate the advantages of these two methods without increasing their side effects. CSE is therefore now used in several countries including Vietnam. In the other hand, GA is still a frequent anesthetic method for preeclampsia women in Vietnam. Therefore, we conduct this research to compare the analgesia efficacy as well as the maternal/neonatal outcomes of three anesthetic method for cesarean delivery on severe preeclampsia women: SA, CSE and GA.

2. Material and method

* Material

Severe preeclamptic patients (based on criteria of French Association of Anesthesiologist and French Association of Gyneco-Obstetricologist 2007). admitted in National Obstetric and Gynecology Hospital between 2009 and 2011, undergoing cesarean section, were included in the current study. Parturients must be at 32 weeks or more gestational age, ASA II or III, presenting no-contraindication for spinal anesthesia nor neurological disturbances and must sign the informed written consent.

The exclusion criteria in this study were as follows: patients having multiple gestations or fetal congenital anomalies, patients presenting general diseases prior to pregnancy; patient having coagulopathy, thrombocytopenia with platelet count less than 100 G/l, patients having abruptio placenta or placenta previa, sepsis, neurological problems, hypovolemia, or pulmonary edema; HELPP syndrom or with fetal complications.

* Method

Clinical Randomized controlled trial, comparing the use of SA and CSE versus GA in severe preec-lamptic parturients undergoing CS. All patients were given an IV infusion of 5 ml/kg lactated Ringer's solution over 15 min before the anesthetic procedure. Monitoring included BP, HR, FR and SpO2. Baseline BP

_Maternal, neon;

and HR were recorded in the operating room (mean of three consecutive measurements taken every two minu-tes)before anesthesia procedure.

180 parturients were randomly allocated to three groups. Group 1(n=60) received general anaesthesia consisting of propofol 2 mg/kg, fentanyl 0.1 mg, succi-nylcholin 1 mg/kg, tracurium 0.3 mg/kg and isoflurane 0,5 - 1%. Group 2 (n = 60) received a spinal anesthesia consisting of 7 - 8.5 mg of bupivacaine 0.5%, 30 mcg of fentanyl and 100 mcg of preservative-free morphine at L2-3. Group 3 (n = 60) received CSE (Combined spinal - epidural anesthesia) consisting of 5 - 6.5 mg of bupivacaine and 30 mcg of fentanyl (for spinal anesthesia) and 100 - 250 mg of lidocaine (for epidural anesthesia) at L2-3.

Blood pressure, Heart rate were recorded immediately after anaesthesia induction, every minute for first 10 mins, then every 2 mins till completion of opera-tion(T1 to T22). Maternal VAS and side effects were recorded during 48 hours post-operative, firstly every hour for the first six hours and then every 6 hours (H1 to H48).

Newborn babies were assessed regarding the term, gestational age, Apgar score at 1 and 5 minutes, heart and respiratory rate after resuscitation and umbilical artery parameters.

Results are presented in below tables and charts.

Table 1.

l characteristics

Group 1 (n = 60) Group 2 (n = 60) Group 3 (n = 60) P value

Age (year) 29.63 ± 5.52 30.13 ± 5.53 30.05 ± 5.54 > 0.05

Height (cm) 156.7 ± 3.9 154.6 ± 4.6 155.3 ± 50 > 0.05

Weight (kg) 60.07 ± 7.80 64.18 ± 9.30 61.60 ± 8.27 > 0.05

Gestational age (week) 34.89 - 2.45 35.13 ± 2.38 35.21 ± 2.26 > 0.05

Length of preeclampsia management prior CS (days) 5.58 ± 6.53 5.03 ± 7.04 4.9 ± 6.15 > 0.05

ASA II ASA III 8 (13.3) 52 (86.7) 11 (18.33) 49 (81.67) 6 (10) 54 (90) > 0.05 > 0.05

Nulliparous 31 (51.7) 33 (55) 29 (48.3) > 0.05

Headache 9 (15) 7 (11.67) 8 (13.13) > 0.05

Epigastric pain 6 (10) 6 (10) 4 (6,67) > 0.05

Edema 46 (76.67) 51(85) 41 (68.33) > 0.05

BP > 160/110 mmHg 50 (83.33) 53 (88.33) 49 (81.67) > 0.05

Proteinurie> 3,5 g/l 40 (66.67) 33 (55) 39 (65) > 0.05

Creatinin> 100 ^mol/l 7 (11.7) 1 (1.67) 5 (8.33) > 0.05

GOT, GPT > 3 normal 11 (18.33) 6 (10) 7 (11.67) > 0.05

Data are presented as mean ± SD, n(%), or median (range) (Source: Author's summary from prospective data)

Data of maternal, neonatal characteristics did not differ statistically among parturients in three study groups.

Table 2.

Anesthesia and surgical characteristics

Group 1 (n = 60) Group 2 (n = 60) Group 3 (n = 60) P value

Duration of anesthesia procedure (min) 3.15 ± 1.12 4,60 ± 1.11 8.86 ± 1.81 > 0.05

Duration from anesthesia induction to skin incision (min) 3.15 ± 1.12 7.3 ± 2.2 9.96 ± 3.52 > 0.05

Duration from skin incision to delivery (min) 4.85 ± 0.83 5.08 ± 1.06 5.37 ± 0.99 > 0.05

Duration from uterus incision to delivery (min) 1.34 ± 0.84 1.22 ± 0.45 1.4 ± 0.33 > 0.05

Duration of cesarean section (min) 30.73 ± 5.50 29.95 ± 6.36 29,67 ± 5,86 > 0.05

Quality of anesthesia Good Normal Bad 60(100) 0 0 57 (95) 3 (5) 0 60 (100) 0 0 > 0.05

Abdominal muscle relaxing Good Normal Bad 60(100) 0 0 56 (93.33) 4 (6.67) 0 59 (98.33) 1 (1.67) 0 > 0.05

Data are presented as mean ± SD, n(%), or median (range) (Source: Author's summary from prospective data)

7 "i 6 -5 -

4 -

3 -

1 -

0 -

HI H2 H3 H4 H5 H6 H12 HIS H24 H36 H4S

Figure 2. VAS score (Source: Author's summary from prospective data)

VAS and CSE

—*— Group 1 —■— Group 2 Group 3

score on cought of spinal anesthesia group group (p < 0,05).

group were lower than general anesthesia

roup 1

t T :: ■ - -m -H T Tl T r X X T I T

i ± i £ lltlii

Ap # # 45 4, ^ ^ ^ # f # #

Figure 2. Systolic blood pressure variations during the operation (Source: Author's summary from prospective data)

In general anesthesia (GA) group, the systolic intubation. While in spinal anesthesia (SA) group and blood pressure increased from third minute, reached CSE group, the systolic blood pressure lightly demaximal value in fourth minute, at the time of tracheal creased and stayed stable during operation.

Table 3.

Changes in Blood Pressure and Heart rate during anesthesia

Group 1 (n = 60) Group 2 (n = 60) Group 3 (n = 60) P value

Blood Pressure decrease from baseline > 30% 0 13 (21.67)"^ 7 (11.67)* < 0.05

Blood Pressure increase from baseline > 30% 11 (18.33) 0* 0* < 0.05

Heart rate decrease from baseline > 20% 0 12 (20)* 10 (16.67)* < 0.05

Heart rate increase from baseline > 20% 31 (51.67) 9 (15)* 7 (11.67)* < 0.05

Data are presented asn(%) * p< 0,05 - compare to group 1 f p< 0,05 - compare to group 2 (Source: Author's summary from prospective data)

In our study, none of the dangerous complication of hemorrhage, epidural hematoma... is observed. Mild side anesthesia such as pulmonary edema, cerebral effects are reported and presented in table 3.

Table 4.

Comparison of maternal side effects in three groups

Group 1 (n = 60) Group 2 (n = 60) Group 3 (n = 60) P value

Nausea, vomiting 3 (5) 8 (13.33) 4 (6.67) > 0.05

Itching 0 13 (21.67)* 3 (5)*t < 0.05

Shivering 0 7 (11.67)* (18.33)*t < 0.05

Urinary retention 1 (1.67) 2 (3.33) 1 (1.67) > 0.05

Headache 0 1 (1.67) 1 (1.67) > 0.05

Throat pain 8 (13.33) 0* 0* < 0.05

Data are presented as n(%) * p< 0.05 - compare to group 1 f p< 0.05 - compare to group 2 (Source: Author's summary from prospective data)

Table 5.

Neonatal weight, Apgar score and neonatal umbilical arterial blood gas data

Group 1 (n = 60) Group 2 (n = 60) Group 3 (n = 60) P value

Neonatal weight (g) 1825.4 ± 620 (800 -3900 1856.9 ± 668.1 (800 - 3600) 1843.3 ± 466.6 (900 - 3000) > 0.05

Apgar score at 1 min 6.7 ± 1.9 (3 - 9) 8.4 ± 0.7 (7 - 9) 8.5 ± 0.9 (6 - 9) < 0.05

Apgar score at 5 min 8.4 ± 1.5 (3 - 10) 9.3 ± 0.7 (8 - 10) 9.4 ± 0.8 (7 - 10) > 0.05

pH 7.29 ± 0.14 7.35 ± 0.08 7.35 ± 0.88 > 0.05

BE -0.36 ± 6.03 2.1 ± 4.86 1,2 ± 4.24 > 0.05

HCO3- 25.45 ± 4.79 27.20 ± 6.41 1.2 ± 4,24 > 0.05

Lactat 2.43 ± 0.64 3.08 ± 1.07 2.54 ± 0.81 > 0.05

Data are presented as mean ± SD, or median (range) (Source: Author's summary from prospective data)

Median 1-min Apgar scores were significantly lower in the general anesthesia group compare to spinal group and to CSE group (p < 0,05).

Neonatal umbilical arterial blood gas data

There were no significant differences of neonatal umbilical arterial blood gas data between three groups. Median umbilical arterial pH in three group were: 7,29± 0,14; 7,35 ± 0,08; 7,35 ± 0,88.

Quality of per-operative anesthesia and postoperative analgesia of the three anesthetic methods:

Quality of general anesthesia method is evaluated based on a PRST scale (Pressure, Rate heart, Sweating, Tearing) of Evans. In our study, PRST score was 2,74 ± 0,68 before delivery and was 2,13 ± 0,82 after delivery. PRST score < 3 shows evidence of no awakeness during operation.

Quality of regional anesthesia method is evaluated based on the Abouleizh scale. In spinal anesthesia group, 95% was evaluated good, 5% was normal (maximal level block in T6, muscle relaxing was't enough for delivery); in CSE group: 100% was good quality.

Motor block grade: In our study, 41.67% of spinal anesthesia group and 53.33% of CSE group obtained grade 3 of Bromage motor block. Another criteria of analgesia effect is the degree of abdominal muscle relaxing, a required favorable condition for the surgeon to get the newborn. In this study, 93.33 % of group 2 (SA), 98.33 % of group 3 (CSE) obtained good abdominal muscle relaxing and these percentages are not different from the group 1 (GA).

Post-operative analgesia effects. Comparing VAS score in static and dynamic position, CSE group presented best quality of pain relief with the lowest VAS score (p < 0.05).

The side effects on the mother. There is any dangerous anesthetic complication (pulmonary edema, cerebral hemorrhage, epidural hematoma) reported in this study. Somes side effects were observed: The hypertensive response to endotracheal intubation in general anesthesia group (group 1): During endotracheal intubation, systolic blood pressure and diastolic blood pressure increase. Increased blood pressure more than 30% baseline was recorded in 18,33% of patient. The mean of arterial blood pressure increased is 23,4 ± 4,6 mmHg, which was lower than data reported by Ramanathan (31 mmHg) and Hodgkinson (45 mmHg) [5], [6].

Hypotention in regional anesthesia group (Group 1 and 2): 21.67% of spinal anesthesia and 11.67% of CSE group presented a deacrease of more than 30% baseline arterial blood pressure. This result is similar to data reportde by Aya (24.4%) but lower than Visalyaputra's result (51%) [4], [7]. It is possibly related to a hight dose of bupivacaine (11 mg) used in Visalyaputra's study.

In this study, we observed some other mild side effects: nauseaor vomiting, itching, shivering or throat pain. 5 % of group 1, 13.33 % of group 2, 6.67 % of group 3 experienced nausea or vomiting. Itching frequency is higher among SA group than CSE group and general anesthesia group (21.67%, 5% and 0% accordingly, p <0.05). Throat pain was observed in general anesthesia groups only (11.67%)due to endo-tracheal intubation.

The side effects in the newborn. The first minute Apgar score of the newborn was significantly lower in general anesthesia group than in spinal group or CSE group (6.7 ± 1.8 in group 1; 8.4 ± 0.7 in group 2 and 8.5 ± 0.8 im group 3). At fifth minute, the Apgar score was not different between newborns from three groups. Ra-

manathan and Visalyaputra [6], [7] have recorded similar result. Effect of anesthetics and morphine drugs which pass to the placenta is one of explaining reasons for neonatal respiratory depression in GA group. Umbilical artery acid - base status is also used to assess the fetal condition. There is not difference of umbilical artery parameters (pH, pCO2, pO2, standar bicarbonate and base deficit) between the three groups.

3. Conclusion

Spinal anesthesia or combined spinal epidural anesthesia used for cesarean delivery in pregnancies complicated by severe preeclampsia present good per-oper-ative anesthesia and good post-operative analgesia and good stability of hemodynamic. The two regional anesthetic methods also showless side effects on maternal and neonatal health comparing to the GA group.

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