British Journal of Anaesthesia 89 (4): 55661 (2002)

Randomized, double-blind comparison of different inspired oxygen fractions during general anaesthesia for Caesarean section
W. D. Ngan Kee1*, K. S. Khaw1, K. C. Ma2, A. S. Y. Wong1 and B. B. Lee1
1

Department of Anaesthesia and Intensive Care, 2Department of Paediatrics, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, China
*Corresponding author
Background. The optimal inspired oxygen fraction FIO2 for fetal oxygenation during general anaesthesia for Caesarean section is not known. Methods. We randomized patients having elective Caesarean section to receive one of the following: FIO2 0.3, FIN2O 0.7 and end-tidal sevourane 0.6% (Group 30, n=20); FIO2 0.5, FIN2O 0.5 and end-tidal sevourane 1.0% (Group 50, n=20), or FIO2 1.0 and end-tidal sevourane 2.0% (Group 100, n=20) until delivery. Neonatal outcome was compared biochemically and clinically. Results. At delivery, for umbilical venous blood, mean PO2 was greater in Group 100 (7.6 (SD 3.7) kPa) compared with both Group 30 (4.0 (1.1) kPa, P<0.0001) and Group 50 (4.7 (0.9) kPa, P=0.002) and oxygen content was greater in Group 100 (17.2 (1.6) ml dl1) compared with both Group 30 (12.8 (3.6) ml dl1, P=0.0001) and Group 50 (13.8 (2.6) ml dl1, P=0.0001). For umbilical arterial blood, PO2 was greater in Group 100 (3.2 (0.4) kPa) compared with Group 30 (2.4 (0.7) kPa, P=0.003), and in Group 50 (2.9 (0.8) kPa) compared with Group 30 (2.4 (0.7) kPa, P=0.04); oxygen content was greater in Group 100 (10.8 (3.5) ml dl1) than in Group 30 (7.0 (3.0) ml dl1, P<0.01). Apgar scores, neonatal neurologic and adaptive capacity scores, and maternal arterial plasma concentrations of epinephrine and norepinephrine before induction and at delivery were similar among groups. No patient reported intraoperative awareness. Conclusions. Use of FIO2 1.0 during general anaesthesia for elective Caesarean section increased fetal oxygenation. Br J Anaesth 2002; 89: 55661 Keywords: anaesthesia, depth; anaesthesia, obstetric; anaesthetics volatile, sevourane; oxygen, inspired concentration; partial pressure, oxygen Accepted for publication: April 2, 2002

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The optimum inspired oxygen fraction FIO2for general anaesthesia for Caesarean section is unclear. Early papers suggested that an FIO2 of 0.5, combined with 50% nitrous oxide and a low concentration of a volatile agent was optimum,1 and this continues to be the most commonly used technique in the United Kingdom.2 However, subsequent reports have advocated both smaller3 and greater4 5 values of FIO2. The different ndings may result from differences in study design. Confounding factors that make interpretation of earlier studies difcult include lack of lateral uterine displacement,6 7 inclusion of both labouring and nonlabouring patients,35 incomplete or undescribed methods

of randomization3 58 and inadequate compensation for changes in anaesthetic depth when varying FIO2.3 68 Furthermore, previous studies used umbilical arterial and venous PO2 to calculate fetal haemoglobin oxygen saturation, taking into account the characteristics of the fetal oxyhaemoglobin concentration curve.5 No previous study has directly measured the effect of maternal FIO2 on umbilical cord blood oxygen content.

Presented in part as a free paper at the 10th European Society of Anaesthesiologists and 24th European Academy of Anaesthesiology meeting, Nice, France, April 2002.

The Board of Management and Trustees of the British Journal of Anaesthesia 2002

FIO2 in general anaesthesia for Caesarean section

We set out to compare the effect of FIO2 of 0.3, 0.5 and 1.0 on umbilical cord blood oxygen content in patients having elective Caesarean section under general anaesthesia. To achieve equivalent depth of anaesthesia among groups, we calculated equipotent doses of inhaled anaesthetics and measured and closely regulated circuit anaesthetic concentrations. Because light anaesthesia can increase maternal circulating catecholamines and cause uteroplacental vasoconstriction,4 5 we measured maternal arterial plasma concentrations of epinephrine and norepinephrine before induction and at delivery. Neonatal outcome was compared biochemically by measurement of umbilical venous and arterial blood gases and oxygen content using co-oximetry, and clinically by assessment of neonatal Apgar scores and neurologic and adaptive capacity scores (NACS).

Methods
After obtaining approval from the Clinical Research Ethics Committee of the Chinese University of Hong Kong, we consecutively recruited 60 ASA I and II women with term singleton pregnancies having elective Caesarean section under general anaesthesia. All patients gave written informed consent. Patients with pre-existing or pregnancyinduced hypertension, cardiovascular or cerebrovascular disease or known fetal abnormalities were excluded. Patients were given oral ranitidine 150 mg the night before and on the morning of surgery and 30 ml 0.3 M sodium citrate on arrival in the operating theatre. Standard monitoring included non-invasive arterial pressure measurement, electrocardiography and pulse oximetry. A wide-bore i.v. catheter was inserted under local anaesthesia and a slow infusion of lactated Ringer's solution was started. Patients were then randomly allocated to one of three groups by drawing of sequentially numbered sealed envelopes that each contained a computer-generated randomization code. Each group received a different inspired oxygen fraction during the period from immediately after induction to delivery. The circuit oxygen analyser was calibrated immediately before each case and lateral uterine displacement was achieved by tilting the operating table to the left. After preoxygenation, rapid sequence induction with cricoid pressure was achieved using thiopental 4 mg kg1 and succinylcholine 1.5 mg kg1. Atracurium was given as required for further muscle relaxation as indicated by a peripheral nerve stimulator. The lungs were ventilated to maintain end-tidal carbon dioxide concentration of 4.3 kPa. For maintenance of anaesthesia, we used sevourane9 as the volatile agent because of its low bloodgas partition coefcient. Concentrations of oxygen, nitrous oxide and sevourane were adjusted according to group allocation: Group 30 received FIO2 0.3, FIN2O 0.7 and sevourane adjusted to maintain end-tidal concentration of 0.6%; Group 50 received FIO2 0.5, FIN2O 0.5 and end-tidal sevourane 1.0%; and Group 100 received FIO2 1.0 and end-tidal

sevourane 2.0%. These inspired fractions were chosen to provide approximately equivalent MAC values. A circle circuit with a fresh gas ow of 6 litre min1 was used and for all patients the sevourane vaporizer was initially set at 6% for the rst 60 s in order to prime the circuit and was then adjusted as required to maintain the allocated end-tidal concentration. Oxygen and anaesthetic concentrations were measured using the modules integrated into the anaesthesia ger, Telford, machine (Narkomed 4, North American Dra PA, USA). All monitoring data were downloaded to a Macintosh computer using software developed within our department. Patients were not informed of the group allocation. One anaesthetist was responsible for controlling the delivery of the anaesthetic. Separate investigators were responsible for the blood sampling and analysis. To mask these investigators and the surgeon to the treatment, the anaesthesia machine was turned away so the monitors were not visible to them. Maternal arterial haemoglobin oxygen saturation was measured continuously using pulse oximetry. The contingency plan for any patient who developed an SpO2 95% was to increase the FIO2 to the next highest group, and for any patient who developed hypotension was to increase the rate of i.v. uid administration. Times of skin incision, uterine incision and delivery were recorded by stopwatch. Approximately 10 ml maternal arterial blood was taken by radial artery puncture before pre-oxygenation and at the time of delivery. Each sample was divided into aliquots for measurement of blood gases, oxygen content and plasma concentrations of epinephrine and norepinephrine. Samples of arterial and venous blood were taken from a doubleclamped segment of umbilical cord for measurement of blood gases and oxygen content. After delivery, morphine 0.15 mg kg1 and oxytocin 10 IU were given i.v. Anaesthesia was then maintained using FIO2 0.3, FIN2O 0.7 and end-tidal sevourane 0.6% in all patients. After delivery, the neonate was assessed by a paediatrician (KCM) who was not aware of the treatment, who recorded Apgar scores 1 min and 5 min after birth and NACS 15 min and 2 h after birth. At the end of surgery, residual neuromuscular block was antagonized using neostigmine and atropine. Blood loss was assessed by measuring blood in the suction bottle minus liquor, weighing wet swabs and estimating blood on drapes and on the oor. Each patient was visited on the rst day after operation by a research nurse, who asked the patient if she was able to recall any intraoperative events or remembered any dreams during the operation.

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Laboratory analyses
All blood samples were drawn into heparinized syringes. Samples for blood-gas and oxygen-content analysis were immediately placed in ice. Blood gases were measured using a Ciba-Corning 278 Blood Gas System blood gas

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analyser (Ciba-Corning, Medeld, MA, USA). Oxygen content and total haemoglobin concentration were measured using an IL 482 Co-oximeter (Instrumentation Laboratory, Lexington, MA, USA) with correction for 70% fetal haemoglobin. Blood samples for catecholamine analysis were immediately put into lithium-heparin tubes containing metabisulphite as an antioxidant and the tubes were immediately placed in ice. These were centrifuged at 4C and the plasma was separated and stored at 70C pending batch analysis. Norepinephrine and epinephrine were measured by high performance liquid chromatography. Catecholamines were extracted with alumina, analysed on a reverse-phase Ultrasphere IP C18 column (Beckman Instruments Inc., Altex Division, San Ramon, CA, USA) and detected by an electrochemical method on an ESA 5100A coulometric detector (Environmental Science Associates, Bedford, MA, USA). The within-day coefcients of variation for norepinephrine and epinephrine were 7.06% and 8.48%, respectively, and the between-day coefcients of variation were 10.69% and 12.69%, respectively. The assay was linear to the lower limit of detection, which was 25 pg ml1 for both norepinephrine and epinephrine.

Table 1 Patient characteristics and surgical times. Values are mean (SD or range) Group 30 (n=20) Age (yr) Weight (kg) Height (cm) Induction to delivery time (min) Uterine incision to delivery time (s) Estimated blood loss (ml) 34 (2741) 65 (9) 157 (5) 12.2 (5.5) 97 (39) 795 (413) Group 50 (n=20) 34 (2641) 64 (10) 156 (4) 11.4 (2.3) 85 (35) 626 (310) Group 100 (n=20) 35 (2743) 66 (5) 157 (5) 13.3 (4.7) 103 (48) 821 (564) P

0.8 0.8 0.9 0.4 0.4 0.4

Statistics
Prospective power analysis was based on data from our previously published work.10 The primary outcome was dened as the umbilical venous oxygen content. We calculated that a sample size of 17 patients per group would have 90% power to detect a 20% difference in oxygen content among groups with an alpha value of 0.05. To allow for possible difculties with sample collection, we increased the sample size to 20 per group. Intergroup comparisons were made using analysis of variance with post-hoc pairwise comparisons using Scheffe's procedure. Single-variable intragroup comparisons were made using the paired t-test. Nominal data were analysed using the chi square test and Fisher's exact test. Analyses were performed using Statview for Windows 4.53 (Abacus Concepts Inc., Berkeley, CA, USA). P<0.05 was considered signicant.

Results
Patient recruitment took 2 yr and 7 months, from October 1998 to April 2001. The relatively long time required to complete data collection reects the low usage of general anaesthesia for Caesarean section in our unit (approximately 12% for elective cases during the study period). The indications for general anaesthesia were similar among groups and included placenta praevia (36), patient refusal of regional anaesthesia (20), and contraindication for regional anaesthesia because of low platelet count, antiplatelet medication or spinal deformity (4). Patient characteristics and surgical details were similar among groups (Table 1).

In general, FIO2 and anaesthetic concentration could be well maintained in the target ranges, although it was noted that for patients in Group 100, FIO2 of exactly 1.0 was difcult to achieve because of the diluting presence of other gases and vapours. No patient required an increase of the allocated FIO2 because of a low SpO2. There was insufcient sample volume for analysis from one patient in Group 30 for umbilical venous blood, from one patient in Group 50 for maternal arterial blood and from two patients in Group 50 and three patients in Group 100 for umbilical arterial blood. The paediatrician investigator (KCM) was not available for three cases in Group 30, three in Group 50 and one in Group 100; in these cases the neonate was assessed by the duty paediatrician, who assessed Apgar scores but not NACS. No patient reported recall of intraoperative events. One patient in Group 50 reported experiencing intraoperative dreams but was not distressed by this. Maternal arterial blood gases, haemoglobin concentration and oxygen content are shown in Table 2. Values for PaO2 at delivery increased with increasing FIO2, but there was no difference in maternal arterial oxygen content among groups or between baseline and delivery values within groups. Umbilical cord gases and haemoglobin concentration are shown in Table 3 and oxygen content is shown in Figure 1. PO2 was signicantly different among groups for both umbilical venous (P<0.0001) and arterial (P=0.002) blood. Post-hoc analysis showed that for umbilical venous blood, PO2 was greater in Group 100 than in Group 30 (P<0.0001) and in Group 100 compared with Group 50 (P=0.002). For umbilical arterial blood, PO2 was greater in Group 100 than in Group 30 (P=0.003) and in Group 50 compared with Group 30 (P<0.05). There were no differences between groups in pH or PCO2. Oxygen content of umbilical blood was signicantly different between groups for both venous (P<0.0001) and arterial blood (P<0.01). Post-hoc analysis showed that for umbilical venous blood, mean oxygen content was greater in Group 100 than in Group 30 (17.2 (SD 1.6) vs 12.8 (3.6) ml dl1, P=0.0001) and in Group 100 compared with Group 50 (17.2 (1.6) vs 13.8 (2.6) ml dl1, P=0.0001). For umbilical arterial blood, oxygen content was

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Table 2 Maternal arterial blood gases, haemoglobin concentration and oxygen content. P values shown are from analysis of variance. Signicant results from post-hoc analysis are indicated as different compared with Group 100 (***P<0.001) and different compared with Group 50 (P<0.001). Values are mean (SD) Group 30 (n=20) Baseline pH PaCO2 (kPa) PaO2 (kPa) Haemoglobin concentration Oxygen content Delivery pH PaCO2 (kPa) PaO2 (kPa) Haemoglobin concentration Oxygen content Group 50 (n=20) Group 100 P (n=20)

(g dl1) (ml dl1) 14.8 (1.4)

7.45 (0.02) 4.0 (0.3) 14.7 (3.5) 10.9 (1.0)

7.44 (0.02) 7.45 (0.02) 4.2 (0.3) 4.0 (0.4) 14.1 (1.2) 14.4 (2.3) 11.3 (1.3) 11.3 (1.1) 15.3 (1.8) 15.3 (1.6)

0.4 0.2 0.7 0.4 0.6

(g dl1) (ml dl1) 14.5 (1.5)

7.41 (0.03) 7.43 (0.04) 7.41 (0.03) 0.4 4.3 (0.4) 4.4 (0.4) 4.4 (0.4) 0.4 19.8 (3.1)*** 31.5 (8.0) *** 60.9 (10.1) <0.0001 10.5 (0.9) 10.8 (1.1) 11.0 (2.3) 0.6 14.2 (2.0) 14.4 (1.9) 0.9

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Table 3 Umbilical cord blood gases and haemoglobin concentration. P values shown are from analysis of variance. Signicant results from post-hoc analysis are indicated as different compared with Group 100 (**P<0.01, ***P<0.001) and compared with Group 50 (P<0.05). Values are mean (SD) Group 30 (n=20) Group 50 (n=20) Group 100 (n=20) P

Umbilical venous pH 7.34 (0.03) 7.36 (0.03) 7.35 (0.04) 0.3 PCO2 (kPa) 5.8 (0.6) 5.8 (0.4) 5.5 (0.6) 0.3 PO2 (kPa) 4.0 (1.1)*** 4.7 (0.9)** 7.6 (3.7) <0.0001 Haemoglobin 14.4 (1.3) 13.7 (1.4) 14.0 (1.2) 0.3 concentration (g dl1) Umbilical arterial pH 7.31 (0.03) 7.32 (0.04) 7.30 (0.03) 0.2 6.8 (0.7) 6.5 (0.7) 6.8 (0.6) 0.4 PCO2 (kPa) PO2 (kPa) 2.4 (0.7)** 2.9 (0.8) 3.2 (0.4) 0.002 Haemoglobin 14.2 (1.5) 13.6 (1.5) 14.2 (2.4) 0.5 concentration (g dl1)

Fig 1 Umbilical venous (A) and arterial (B) cord blood oxygen content. **P<0.01, signicantly different from Group 100. ***P<0.001, signicantly different from Group 100.

greater in Group 100 than in Group 30 (10.8 (3.5) vs 7.0 (3.0) ml dl1, P<0.01). The results of clinical assessment of the neonates are shown in Table 4. There was no difference among groups in the proportion of Apgar scores <7 at 1 min. All neonates had Apgar scores >7 at 5 min. NACS were similar among groups at 15 min and at 2 h. Eight neonates in Group 30, three in Group 50 and ve in Group 100 required a brief period of assisted mask ventilation immediately after birth (P=0.2); of these, one neonate in Group 30 and one neonate in Group 100 required tracheal intubation for suction. Three neonates were admitted to the neonatal intensive care unit: two in Group 100 because of tachypnoea and one in Group 30 because of cyanosis on feeding. In none of these cases was the admission considered to be related to the anaesthetic technique.

Maternal arterial catecholamine concentrations are shown in Table 5. In each group, maternal arterial plasma concentrations of epinephrine were higher at delivery than at baseline (all P<0.05). Similarly, in each group, plasma concentrations of norepinephrine were higher at delivery than at baseline (all P<0.01). However, there were no differences in plasma concentrations of either epinephrine or norepinephrine between groups at either baseline or at delivery.

Discussion
Our study showed that in patients having general anaesthesia using nitrous oxide and sevourane, oxygen transfer to the fetus was greatest with the use of an FIO2 near 1.0 compared with FIO2 of 0.5 and 0.3. This was reected by a greater umbilical venous oxygen content in Group 100 compared with Group 30 and Group 50 and greater umbilical arterial oxygen content in Group 100 compared with Group 30.

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Table 4 Clinical neonatal outcome. Values for neurologic and adaptive capacity score (NACS) are mean (SD) Group 30 (n=20) Apgar score at 1 min 46 (n) > 7 (n) Apgar score at 5 min 46 (n) > 7 (n) Assisted ventilation required at birth (n) Admitted to neonatal intensive care (n) NACS at 15 min NACS at 2 h Group 50 (n=20) Group 100 (n=20) P Table 5 Maternal arterial plasma catecholamine concentrations. Values are mean (SD) Group 30 (n=20) Baseline Epinephrine (pg ml1) Norepinephrine (pg ml1) Delivery Epinephrine (pg ml1) Norepinephrine (pg ml1) Group 50 (n=20) Group 100 (n=20) P

7 13 0 20 8 1 31.5 (4.7) 35.8 (3.3)

3 17 0 20 3 0 32.8 (3.6) 36.9 (1.9)

5 15 0 20 5 2 31.7 (4.8) 36.0 (3.3)

0.3 0.3

142 (63) 275 (103) 203 (92) 451 (150)

154 (85) 362 (223) 292 (279) 501 (281)

122 (76) 307 (131) 223 (143) 483 (277)

0.4 0.2 0.3 0.8

0.2 0.3 0.7 0.5

These ndings support the earlier work by Bogod, Piggott and colleagues,4 5 who also reported that the use of 100% oxygen improved fetal oxygenation compared with 50% oxygen. As 100% oxygen increased umbilical venous oxygen tension, they postulated that because of the high oxygen afnity of fetal haemoglobin, this should correspond to a signicant increase in oxygen content. We have conrmed this by measuring oxygen content using co-oximetry. Bogod, Piggott and colleagues also emphasized the importance of adjusting the concentration of volatile anaesthetic to compensate for loss of the anaesthetic contribution from nitrous oxide. This was not done in previous studies6 7 and it was suggested that light anaesthesia could have increased plasma catecholamines and caused placental vasoconstriction.4 5 In our study we found no difference between groups in maternal arterial plasma concentrations of epinephrine and norepinephrine, making it unlikely that differences in depth of anaesthesia contributed to any differences in cord blood results. However, the small sample size should be noted in the interpretation of these data. Retrospective power analysis showed that our study had 80% power to detect a 44% difference in maternal arterial plasma norepinephrine concentration and a 65% difference in maternal arterial plasma epinephrine concentration in Group 100 compared with the other groups. In our study, similar to those of Bogod, Piggott and colleagues, we calculated and administered equivalent MAC values of inhalational anaesthetics to each group. We also initially administered a high concentration of volatile agent to rapidly increase alveolar anaesthetic concentration. However, we limited this initial period of overpressure to only 1 min, compared with 5 min in the previous studies. Thereafter we titrated anaesthetic delivery according to end-tidal concentration, which was not done in the previous studies. This was facilitated by our choice of sevourane, because its low bloodgas partition coefcient results in rapid changes of alveolar concentration. In retrospect, we might have been further able to conrm equivalent depth of anaesthesia among groups by use of

bispectral index (BIS) monitoring, although few data are available on BIS monitoring in pregnant patients. Previously, Lawes and colleagues3 investigated different values of FIO2 during general anaesthesia for Caesarean section. In contrast to our ndings, they found no difference in umbilical venous PO2 in patients who received an FIO2 of 0.33 compared with patients who received an FIO2 of 0.5. However, that study was not fully randomized and was only partially blinded, there was no compensatory adjustment of isourane concentration, and both labouring and nonlabouring patients were included. Although the authors concluded that use of 33% oxygen appeared to be safe, they did not include a group that received an FIO2 of 1.0 for comparison. Perreault and colleagues11 investigated administration of 100% oxygen during the period between hysterotomy and birth during general anaesthesia for Caesarean section. Compared with a group that received 50% oxygen, they found no difference in umbilical venous or arterial PO2. Notably, however, no adjustment of volatile anaesthetic was made after discontinuing nitrous oxide in the 100% group and four out of 10 patients reported intraoperative awareness. This serves to emphasize the importance of increasing the concentration of volatile agent and monitoring circuit concentration when using 100% oxygen. In that study, two infants in the 100% group had low early Apgar scores, which was not explained. We found no difference in the clinical condition of the neonates, assessed using Apgar scores and NACS. However, signicant differences would be difcult to detect in healthy uncomplicated elective cases in whom outcome was already expected to be favourable. Further research is required to determine whether the increase in oxygen delivery we found in elective cases could lead to differences in clinical outcome in emergency cases when there is fetal distress. Such an advantage was suggested by Piggott and colleagues5 who found that neonates born to mothers who received 100% oxygen during emergency Caesarean section had a smaller requirement for oxygen and positive-pressure ventilation compared with those delivered to mothers who received 50% oxygen. We chose to use NACS as a method of evaluating potential differences among groups exposed to different anaesthetic combinations, including relatively

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high concentrations of sevourane and found no difference between groups. Retrospective power analysis showed that our study had 80% power to detect a mean difference in NACS score of 4 points at 15 min and 3 points at 2 h in Group 100 compared with the other groups. However, since this study was planned, the validity of NACS has been questioned.12 13 Finally, although we have found that a high FIO2 improved fetal oxygenation, the potential harmful effects of oxygen should be considered. Maternal hyperoxia could provoke vasoconstriction in the fetoplacental unit.14 However, our nding that fetal oxygenation improved in the group that received the highest FIO2 suggests that this is not a signicant concern in elective cases. Hyperoxia also increases the rate of formation of toxic reactive species by superoxide generation.15 In a previous study16 we found that a high FIO2 during regional anaesthesia for Caesarean section resulted in increased maternal and umbilical plasma concentrations of lipid peroxide markers of oxygen freeradical activity. The clinical importance of this is as yet undetermined. We are now investigating the effect of FIO2 on markers of free-radical generation during general anaesthesia for Caesarean section.

4 5 6 7 8 9

10 11 12 13 14 15 16

Acknowledgements
The authors thank the midwives of the Labour Ward, Prince of Wales Hospital, Shatin, Hong Kong, China and research nurses Justina Liu, Floria Ng and Mabel Wong for their assistance with this study. This work was supported by a Direct Grant for Research from the Chinese University of Hong Kong.

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