Eur J Anaesthesiol 2021; 38:1124–1129

ORIGINAL ARTICLE

Effect of intra-operative high inspired fraction of oxygen

on postoperative nausea and vomiting in children
undergoing surgery
A prospective randomised double-blind study
Bikram Kishore Behera, Satyajeet Misra, Manoj Kumar Mohanty and Anand Srinivasan

BACKGROUND Administration of high inspired fraction of
oxygen (FiO2) during anaesthesia has been proposed to
decrease postoperative nausea and vomiting (PONV) in
adults but has not been extensively studied in children.
OBJECTIVES The primary objective of this study was to
evaluate the effect of 80% FiO2 on the incidence of PONV in
children undergoing surgery.
DESIGN Prospective, randomised, study.
SETTING Single-centre, teaching hospital.
PATIENTS Children of either gender in the age group of 5 to
15 years scheduled for elective surgeries were assessed for
eligibility. Emergency surgeries; patients receiving supple-
mental oxygen pre-operatively or on mechanical ventilation;
sepsis; bowel obstruction or ischaemia; poor nutritional
status; anaemia (Hb <8 g%) or surgeries lasting less than
1 h or greater than 4 h were excluded from the study.
INTERVENTIONS After induction of anaesthesia, children
were randomised to receive either 30 or 80% oxygen in air,
till the end of surgery.
MAIN OUTCOME MEASURES Incidence of PONV within
24 h; surgical site infections (SSI)s; serum serotonin and
TNF-a levels and the incidence of postoperative pulmonary
complications (PPC)s were studied.
RESULTS The overall 24 h incidence of PONV was not
different between the low and high FiO2 groups [24 vs.
23%; P ¼ 0.84; odds ratio (OR) 0.92; 95% confidence
interval (CI), 0.44 to 2.06]. The incidence of SSIs (15 vs.
12%; P ¼ 0.61; OR 0.77; 95% CI, 0.28 to 2.10) and PPCs
(12 vs. 8%; P ¼ 0.38; OR 0.59; 95% CI, 0.18 to 1.92) were
not significant between the low and high FiO2 groups,
respectively. Intragroup and intergroup comparisons of
serum serotonin and TNF-a showed no significant difference
either at baseline or at the end of surgery.
CONCLUSION High intra-operative FiO2 of 80% does not
provide additional protection against PONV in children.
TRIAL REGISTRATION The study was registered with Clini-
cal Trials Registry of India (CTRI) with trial registration no:
CTRI/2018/07/014974.
Published online 26 July 2021

Introduction
The most common complication of anaesthesia in chil-
dren is postoperative nausea and vomiting (PONV). The
incidence varies from 10 to 80%.1 Though rarely life-
threatening, it is distressing for both children and their
parents. Management of PONV is multifactorial and
often requires combination therapy.2 Several trials have
investigated the impact of inspired oxygen concentration
(FiO2) and its effects on the peri-operative outcomes; and
many have shown that high FiO2 (>80%) protects against
PONV, reduces the incidence of surgical site infections
(SSI)s, and without increasing the incidence of adverse
respiratory complications.3–8 But, firm conclusions on the
beneficial effects of high FiO2 are still far off and need
further investigations.9–11 Most of these reports are from
heterogenous study settings in the adult general
surgical patients.

From the Department of Anesthesiology & Critical Care (BKB, SM), Department of Pediatric Surgery (MKM) and Department of Pharmacology (AS), All India Institute of
Medical Sciences (AIIMS), Bhubaneswar, Orissa, India
Correspondence to Bikram Kishore Behera, Additional Professor, Department of Anesthesiology & Critical Care, All India Institute of Medical Sciences (AIIMS),
Bhubaneswar, Orissa, India
E-mail: bikrambehera007@gmail.com

0265-0215 Copyright ß 2021 European Society of Anaesthesiology and Intensive Care. Unauthorized reproduction of this article is prohibited.
DOI:10.1097/EJA.0000000000001577
Copyright © European Society of Anaesthesiology and Intensive Care. Unauthorized reproduction of this article is prohibited.

Very few studies have evaluated the effects of high FiO2
on postoperative outcomes in the children and are limited
to children undergoing dental procedures,12 or tonsillec-
tomies.13 Furthermore, these studies did not evaluate the
effect of high FiO2 on the incidence of SSIs and postop-
erative pulmonary complications (PPC)s. In addition, the
effect of high FiO2 is still unexplored in children under-
going other surgeries like abdominal and urological pro-
cedures. The effect of high FiO2 on serotonin levels,
which are implicated in PONV and other inflammatory
markers like TNF-a is also unclear.
Thus, the primary aim of this study was to evaluate the
effect of high FiO2 (80%) on PONV in children under-
going various surgeries under general anaesthesia. Sec-
ondary aims were to evaluate the effect on SSIs, PPCs,
and serum bio-markers.
Methods
This prospective, randomised study was approved by the
Institutional Ethics Committee of AIIMS, Bhubaneswar
(ECR/534/Inst/OD/2014/RR-17) vide letter no. T/IM-F/
17-18/15 on Date: 14 December 2017 and registered with
Clinical Trials Registry of India (CTRI) with Trial reg-
istration no: CTRI/2018/07/014974; principal investigator
Dr Bikram Kishore Behera; date of registration 19 July
2018. The study was conducted from 1 August 2018 to 31
July 2020.
After obtaining informed written consent from parents,
and assent from children above 8 years of age, children of
either gender, in the age group of 5 to 15 years, ASA
physical status I/II and undergoing elective surgery under
general anaesthesia, with a proposed duration of 1 to 4 h
were included in the trial. All patients included in the
study were randomised into two groups: group L (30%
FiO2) and group H (80% FiO2) using a computer-gener-
ated simple randomisation sequence. Random sequence
was generated by the primary investigator, and patients
were enrolled and assigned to either group by the attend-
ing anaesthesiologist. Allocation was concealed in opaque
sealed envelopes.
Emergency surgeries; patients receiving supplemental
oxygen pre-operatively or on mechanical ventilation;
sepsis; bowel obstruction or ischaemia; poor nutritional
status; anaemia (Hb <8 g%); surgeries with an anticipated
duration of less than 1 h or greater than 4 h were excluded
from the study.
Anaesthesia was standardised for all patients. Children
fasted for 2 to 4 h for clear liquids and at least 6 h for milk
and solids. All patients received midazolam 0.5 mg kg1
orally up to a maximum dose of 20 mg along with antibi-
otic prophylaxis, 20 to 30 min before surgery. Standard
monitoring was used including ECG, noninvasive blood
pressure, pulse oximetry, and capnography. Anaesthesia
was induced with propofol 2 to 3 mg kg1 and fentanyl 1
to 2 mg kg1. Neuromuscular blockade was selectively
Copyright © European Society of Anaesthesiology and Intensive Care. Unauthorized reproduction of this article is prohibited.
High FiO2 and PONV in children 1125
used as required by the nature of surgery. Atracurium
0.5 mg kg1 was used for tracheal intubation. An appro-
priate sized Proseal laryngeal mask airway (LMA) (Tele-
flex, USA) was used for patients who were not intubated.
All patients were manually ventilated via face mask with
100% oxygen for 3 min before endotracheal intubation or
LMA placement. Subsequently, after securing the air-
way, patients received 30% oxygen in air in group L (low
FiO2 group), or 80% oxygen in air in group H (high FiO2
group) throughout the intra-operative period. Anaesthe-
sia was maintained with isoflurane (minimum alveolar
concentration 0.9 to 1, with inspired concentration of 1.5
to 2 vol%) and supplemental bolus doses of fentanyl (1 mg
kg1) to keep the heart rate and SBP within 20% of
baseline values. Appropriate regional nerve blocks if
feasible, were performed after securing the airway.
Forced-air warming was used to maintain core body
temperature near 36 8C. All patients received ondanse-
tron 0.1 mg kg1 after anaesthesia induction. Lactated
Ringers’ solution was infused at a rate of 10 ml kg1 h1
throughout the surgery. Patients were mechanically ven-
tilated with a tidal volume of 6 ml kg1, and the respira-
tory rate was adjusted to keep normocapnia (end-tidal
CO2 32 to 38 mmHg). Blood samples were drawn after
induction of anaesthesia and at the end of surgery for
measurement of serum serotonin and TNF-a levels in
both the groups. Muscle relaxants were reversed with
injection neostigmine at the end of surgery.
Postoperatively, the children were observed in the post-
anaesthesia recovery room for 4 h. All patients received
intravenous paracetamol 15 mg kg1 eight hourly. An
anaesthesiologist not involved in the conduct of anaes-
thesia collected the postoperative data. The primary
outcome measure was the incidence of PONV within
24 h. PONV was assessed and recorded by nurses and was
considered if there was an episode of nausea, emesis
(retching and/or vomiting), or both. Early PONV was
defined as within the first four postoperative hours and
delayed PONV was defined as occurring between 4 and
24 h. Rescue antiemetic injection metoclopramide was
administered at a dose of 0.1 mg kg1 after any reported
incidence of PONV.
Secondary outcome measures included any SSIs occur-
ring during the entire length of stay in the hospital. The
surgical wounds were evaluated and reported by a sur-
geon blinded to the randomisation. SSI was defined as
any purulent discharge from the incision site. Any inci-
dence of postoperative desaturation (room air SpO2
<92%), bronchospasm, laryngospasm, airway obstruction
and stridor within the first 24 h were recorded as PPCs. All
patients and outcome assessors were blinded to the
randomisation sequence and the allocated intervention.
Sample size
Administration of 80% oxygen has been shown to halve
the incidence of PONV in adults.6 Children included in
Eur J Anaesthesiol 2021; 38:1124–1129
 1126 Behera et al.

Fig. 1 Consort flow diagram.

Enrollment
Assessed for eligibility (n = 160)

Excluded (n = 22)
♦ Not meeting inclusion criteria (n = 16)
♦ Declined to participate (n = 6)
♦ Other reasons (n = 0)

Randomised (n = 138)

Allocation
Allocated to intervention (n = 70) Group L Allocated to intervention (n = 68) Group H
♦ Received allocated intervention (n = 70) ♦ Received allocated intervention (n = 68)
♦ Did not receive allocated intervention (n = 0) ♦ Did not receive allocated intervention (n = 0)

Follow-Up
Lost to follow-up (n = 0) Lost to follow-up (n = 0)
Discontinued intervention (n = 4) Discontinued intervention (n = 2)

Analysis

Analysed (n = 66) Analysed (n = 66)

♦ Excluded from analysis (Discontinued ♦ Excluded from analysis (Discontinued
intervention) (n = 4) intervention) (n = 2)

our study had more than one risk factor for PONV. Thus,
considering an average baseline incidence of 40% for
PONV in this study and assuming the incidence of
PONV to be halved in children receiving FiO2 of
80%, the calculated sample size was 60 patients per
group. The sample size was powered at 80% allowing
a false-positive rate of 5%. Total planned recruitment
was 140 children to account for dropouts. The incidence
of PONV, SSIs and PPCs were analysed by the Pearson’s
x2 or the Fisher’s exact test. Risk factors for PONV were
additionally analysed using logistic regression. Data
were expressed as median [IQR] or mean  SD for
continuous data, and number (percentage) for categori-
cal data. P value of less than 0.05 (two-tailed) was
considered statistically significant. Data were analysed
using R, Version 3.5.
Results
A total of 160 children were assessed for eligibility over a
2-year period, of which, 132 children completed the
study. The eligibility, recruitment and analysis are shown
in the CONSORT diagram (Fig. 1). Demographic and
baseline characteristics are presented in Table 1.
Sixty-six percent of patients underwent various urological
procedures, 23% underwent gastrointestinal surgeries
and the rest of the children underwent various other
surgeries. The duration of surgery and intra-operative
fentanyl consumption were comparable in both the
groups. The overall 24-h incidence of PONV was not
significantly different between the low and high FiO2
groups, respectively (24 vs. 23%; P ¼ 0.84; OR 0.92; 95%
CI, 0.44 to 2.06). There was also no significant difference

Eur J Anaesthesiol 2021; 38:1124–1129

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 High FiO2 and PONV in children 1127

Table 1 Demographic and baseline characteristics Table 3 Serum biomarker assay

Group L Group H Group L Group H

(30% FiO2) (80% FiO2) (30% FiO2) (80% FiO2)
nU66 nU66 (n U 66) (n U 66)
Age (months) 96 [72 to 123] 108 [72 to 132] TNF-alpha levels (pg ml1)
Sex (M/F) 57/9 52/14 Baseline (T1) 18.3 [9.46 to 26.9] 22.1 [17.4 to 28.8]
ASA I/II 56/10 53/13 End of surgery (T2) 19.0 [16.8 to 28.6] 19.8 [13.7 to 35.6]
Weight (kg) 25 [20 to 31] 25 [18 to 32] Serum serotonin levels (ng ml1)
Duration of surgery (minutes) 102 [75 to 139] 120 [90 to 170] Baseline (T1) 52.5 [32.7 to 52.8] 52.5 [36.3 to 52.8]
Intra-op fentanyl consumption (mg) 62 [50 to 80] 70 [50 to 94] End of surgery (T2) 52.6 [30.4 to 53.2] 52.5 [30.0 to 52.9]
Types of surgery: 45/13/8 42/18/6
Urology/gastrointestinal/peripheral Values are in median [IQR]. Intragroup and intergroup comparisons of serum
superficial surgery serotonin and TNF-a showed no significant difference either at baseline or at the
end of surgery. ng/ml, nanogram/ml; pg/ml, picogram/ml.
Values are median [IQR] or number. FiO2, inspired oxygen concentration.

in the incidence of early (<4 h) or late PONV (4 to 24 h) in
both the groups (Table 2).
The incidence of SSIs (15 vs. 12%; P ¼ 0.61; OR 0.77;
95% CI, 0.28 to 2.10) and PPCs (12 vs. 8%; P ¼ 0.38; OR
0.59; 95% CI, 0.18 to 1.92) were also not significant
between the low and high FiO2 groups (Table 2).
Intragroup and intergroup comparisons of serum seroto-
nin and TNF-alpha showed no significant difference
either at baseline (T1) or at the end of surgery (T2)
(Table 3). Logistic regression analysis showed that none
of the independent variables like age, weight, gender,
duration of anaesthesia, intra-operative fentanyl con-
sumption and high FiO2 had any significant effect on
the incidence of PONV.
A subgroup analysis was performed based on children
receiving regional nerve blocks, use of muscle relaxants
and the type of surgery. In the present study, 64%
children in low FiO2 group and 70% children in high
FiO2 group received various regional blocks as deemed
appropriate for the particular surgery. Incidence of
PONV in children who received regional blocks was
19% in the low FiO2 and 22% in the high FiO2 group
(P ¼ 0.75; OR 1.18; 95% CI, 0.41 to 3.34). Children
undergoing gastrointestinal surgeries, laparotomies and
laparoscopic surgeries received muscle relaxants. 54%
children in low FiO2 and 62% children in high FiO2
group received anaesthesia with tracheal tube and were
administered muscle relaxants. The incidence of PONV
was 33% in the low FiO2 group as compared with 19% in
the high FiO2 group in children who received muscle
relaxants (P ¼ 0.21; OR 0.52; 95% CI, 0.18 to 1.46). The
incidence of PONV in children undergoing gastrointes-
tinal surgeries and receiving low FiO2 was 46% whereas it
was 17% in the high-FiO2 group (P ¼ 0.08; OR 0.23; 95%
CI, 0.04 to 1.21). The incidence of PONV in children
undergoing urological surgeries and receiving low FiO2
was 18% whereas it was 26% in high FiO2 group (P ¼ 0.34;
OR 1.64; 95% CI, 0.59 to 4.59). The difference in the
incidence of PONV gastrointestinal surgeries and uro-
logical surgeries were not statistically different in both
low FiO2 group and high FiO2 group (P ¼ 0.22). A total of
24% children in the low FiO2 group and 23% children in
the high FiO2 group required rescue antiemetic medica-
tions.
Discussion
The main findings of this study were a lack of beneficial
effect of high FiO2 on PONV and SSIs in children
undergoing surgery. Importantly, however, high FiO2
did not increase the incidence of PPCs or the level of
inflammatory markers postsurgery.
PONV in children is influenced by many factors that are
related to the patient, surgery and anaesthesia. Four inde-
pendent risk factors for PONV in children are positive
history of PONV, duration of surgery greater than 30 min,
age more than 3 years and strabismus surgery.1 A multi-
modal approach combining nonpharmacological and phar-
macological prophylaxis along with interventions to reduce
baseline risk is ideal for the reduction in the incidence of
PONV.2 Supplemental oxygen has been proposed as a
simple and inexpensive strategy to reduce PONV in
adults.5 However, evidence in children is scarce.

Table 2 Primary and secondary outcome measures

Group L (30% FiO2) (nU66) Group H (80% FiO2) (nU66) OR (95% CI) P value
Overall PONV (24 h) 16 (24%) 15 (23%) 0.92 (0.44 to 2.06) 0.84
Early PONV (0 to 4 h) 15 (23%) 13 (20%) 0.83 (0.36 to 1.92) 0.67
Delayed PONV (4 to 24 h) 5 (8%) 4 (6%) 0.79 (0.20 to 3.07) 1
SSIs 10 (15%) 8 (12%) 0.77 (0.28 to 2.10) 0.61
PPCs 8 (12%) 5 (8%) 0.59 (0.18 to 1.92) 0.56

Values are number (proportion of patients). CI, confidence interval; OR, odds ratio; PPCs, postoperative pulmonary complications; PONV, postoperative nausea and
vomiting; SSIs, surgical site infections.

Eur J Anaesthesiol 2021; 38:1124–1129

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 1128 Behera et al.
Donaldson12 carried out a study, to find out the effect of
high intra-operative FiO2 on PONV in children under-
going dental procedures under general anaesthesia. The
incidence of PONV was 40% in the group that received
30% oxygen and 33% in those that received 80% oxygen.
High FiO2 was not found to significantly reduce PONV.
Izadi et al.13 studied the effect of 80% oxygen in children
undergoing tonsillectomy and did not find any difference
in the incidence of PONV compared with children
receiving 30% oxygen. The findings of our study concur
with the results of Donaldson,12 and Izadi et al.13 that
indicated no additional antiemetic effect of supplemental
oxygen.
The initial studies in adults that showed positive results
of supplemental oxygen on PONV were conducted in
patients undergoing abdominal surgeries.5,6 However,
subsequent meta-analysis in adult patients failed to dem-
onstrate efficacy of high FiO2 on PONV.14
The main trigger for PONV is serotonin release, which is
because of the gut ischaemia that may result from abdom-
inal surgeries and bowel handling. Supplemental oxygen
may minimise the regional gut ischaemia and release of
serotonin, thereby affecting PONV.15–18 Our study
included children undergoing various types of surgery;
66% of them underwent urological surgery, and hence the
proposed mechanism of serotonin release may not be
extrapolated to our study group. This was seen in the lack
of difference in the serotonin levels postsurgery even in
the high FiO2 group.
Supplemental oxygen may also reduce the incidence of
SSIs in adults and has been recommended by the
WHO.19 The US Center for Disease Control and Pre-
vention similarly recommends supplemental oxygen to
reduce SSI risk.20 The proposed mechanism by which
supplemental oxygen reduces SSIs is by increased oxy-
gen arterial content leading to increased subcutaneous
oxygen partial pressure, which is required to support
oxidative killing by neutrophils. Adequate tissue oxygen-
ation is also necessary for collagen deposition, an essential
step in wound healing.21,22 But, whether increased tissue
oxygenation improves wound healing and reduces SSI
remains controversial.
Grief et al. 23 and Belda et al.24 reported a favourable
outcome in reducing SSIs in adults undergoing bowel
surgery and recommended high FiO2 as a practical
method for the reduction of SSI. Hovagumian et al.3 in
their meta-analysis on the effects of high intra-operative
FiO2, concluded that the risk of SSIs is decreased in adult
surgical patients receiving high FiO2. Whereas Kurz
et al.25 demonstrated no effect on SSIs in adult patients
receiving 80% oxygen undergoing bowel surgery, with
similar results to those of the PROXI trial.26 Similarly, in
our study, we did not find any significant difference in the
incidence of SSIs between low and high FiO2 groups, 15
vs. 12%, respectively.
Eur J Anaesthesiol 2021; 38:1124–1129
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Increased concentration of oxygen may lead to atelecta-
sis, and thus increase of PPCs.27–29 The incidence of
PPCs was, however, not significantly higher in our study
in the high FiO2 group. There may be several reasons for
this. Oxygen-induced atelectasis can be reversed with
positive pressure ventilation (PPV) and other recruitment
manoeuvres.30,31 Acosta et al. 32 showed that application
of 5 cmH2O of continuous positive pressure with mask
during induction of anaesthesia with 100% of oxygen
effectively prevented atelectasis in children. Song et al.33
in their study showed that high FiO2 has no effect on
atelectasis in children receiving PEEP and mechanical
ventilation. All children in our study received PPV with
5 cmH2O of positive end-expiratory pressure during
maintenance of anaesthesia. Furthermore, there is no
universal definition of PPCs in children. The incidence
of PPCs will vary depending on the definitions used for a
particular study as well as various patient and surgical risk
factors. Incidence of PPCs ranged from 8 to 12% in our
study, which is similar to that of Mamie et al.34 who
reported an incidence of 13% PPCs in children in the
postanesthesia care unit.
Another proposed toxic effect of high FiO2 is pulmonary
inflammation and the expression of inflammatory cyto-
kines. We measured baseline and postsurgery values of
pro-inflammatory cytokine TNF-a in both groups. The
change from baseline values was not significant in either
group. TNF-a values have been shown to increase with
6 h or more of exposure to supplemental oxygen. This
could explain the lack of significance between the high
and low FiO2 groups in our study wherein most of the
surgeries lasted less than 4 h.
Our study has a few limitations. Antiemetic prophylaxis
was administered to all patients irrespective of the num-
ber of independent risk factors for PONV, and this could
theoretically have affected the incidence of PONV in
both groups. The cause of PONV is multifactorial, and
age above 3 years, duration of surgery greater than 30 min,
inhalational anaesthetics and opioid use along with spe-
cific types of surgery are major influential factors for
PONV. And all these factors were present in both the
groups studied. Hence, an antiemetic prophylaxis was
considered appropriate and administered to all patients.
However, all children received the antiemetic prophy-
laxis with ondansetron following induction of anaesthe-
sia. The duration of a single dose of ondansetron with a
half-life of 3.5 h is approximately 8 h, and thus, at best,
there may have been an effect on early PONV. As our
study was powered to detect difference in the 24 h
incidence of PONV, administration of a single dose of
ondansetron was unlikely to influence the overall inci-
dence of PONV. We did not use ultrasound to evaluate
atelectasis thus, are unable to comment whether there
was an increased incidence of atelectasis in children
receiving high supplemental oxygen. The primary out-
come of our study was PONV. Hence, the results of other

secondary outcomes of our study needs to be interpreted
with caution as the study was not powered for these
outcomes.
Conclusion
In conclusion, we did not find any additional protective
effect of 80% oxygen on PONV and SSIs in children
undergoing elective surgery. Further prospective studies
may be designed without antiemetic prophylaxis and also
sufficiently powered for other important outcomes like
SSIs and PPCs.
Acknowledgements relating to this article
Assistance with the study: none.
Financial support and sponsorship: this study was funded by Insti-
tute Research Grant, AIIMS Bhubaneswar, India.
Conflicts of interest: none.
Presentation: none.
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