Download The effect of small dose sufentanil on emergence agitation in

The effect of small dose sufentanil on emergence agitation in
preschool children undergoing sevoflurane anesthesia for repair of
inguinal hernia
Xiuze Li;Yonghong Zhang;Meijun Zhou;Qing Xia;Wei Li;Qing Lu.
Objective: Emergence agitation is one of the most common complication
in children with sevoflurane anaesthesia.In this study,we investigates
sufentanil on emergence agitation in paediatric patients undergoing
sevoflurane anesthesia,and compare it with fentanyl.
Methods:80 children admitted at the Pediatric surgery of Mianyang
Central Hospital between March 2011 and April 2012 were selected into
this study. The patients were allocated randomly into one of the two
groups receiving sufentanil(GrouS,n = 40) or fentanyl(Group F,n =
40).Emergence agitation scale was measured.Number of patients who
required additional fentanyl during surgery and postoperative rescue
fentanyl at the PACU were recorded. Recovery time as well as adverse
events were also assessed.
Results:Two groups were comparable with regard to demographic data.The
mean emergence agitation scores were significantly lower in the
sufentanil group compared with the fentanyl group(P = 0.001).The
frequency of severe emergence agitation was 27.5% in group sufentanil
1
Department of Anesthesiology and Health statistics,Mianyang Central Hospital,Sichuan,China.
Correspondence: Xiu Ze LI,Department of Anesthesiology,Mianyang Central
Hospital,Sichuan,China. e-mail:[email protected]
and 50% in group fentanyl respectively(P = 0.039).Significantly fewer
children in the sufentanil group received additional fentanyl during
surgery compared to the fentanyl group(P = 0.043)and significantly
fewer children in the sufentanil group received 1 dose of
postoperative rescue fentanyl at the PACU compared to the fentanyl
group(P = 0.015).The incidence of vomiting was significantly higher in
the fentanyl group than in the sufentanil group (p = 0.023).
Conslusion In children with sevoflurane anaesthesia,compared with
fentanyl,sufentanil decrease significantly the incidence of emergence
agitation without delaying the recovery time.
Keywords: emergence agitation,sufentanil,fentanyl,sevoflurane,children
Introduction
On the current application of the anesthetics,sevoflurane come closest
to the ideal inhaled anesthetic（1）,sevoflurane has become one of the
most widely used inhalational agents in paediatric patients,but
postoperative emergence agitation(EA)is a very frequent problem in
children recovering from sevoflurane anesthesia.So far，the exact
etiology of EA is not clear,but it is often observed in preschool
children,and postoperative pain has been regarded as an important
precipitating factor(2,3).
2
Department of Anesthesiology and Health statistics,Mianyang Central Hospital,Sichuan,China.
Correspondence: Xiu Ze LI,Department of Anesthesiology,Mianyang Central
Hospital,Sichuan,China. e-mail:[email protected]
It was found that a protective effect of fentanyl on EA(4-6),but
there is rarely reported literature about the effect of sufentanil on
EA,sufentanil is a potent opioid receptor agonist,and is even stronger
than fentanyl.we assumed that sevoflurane anesthesia assisting with
sufentanil reduces the occurrence of EA while not delaying patient
awakening and recovery after undergoing inguinal hernia repair in
children.
The purpose of this prospective,randomized,doubled-blined study was
to evaluate the effect of intraoperative i.v. administration a small
dose of sufentanil on EA in preschool patients undergoing sevoflurane
anesthesia for elective unilateral inguinal hernia repair,and compare
it with fentanyl.
Approval for this study was obtained from the ethics committee of
our
hospital(Mianyang
Central
Hospital,Sichuan,China),informed
and
written consent was obtained from parents/guardians.
Materials and methods
From March 2011 to April 2012,there were a total of 80 preschool
children (2-6 years old,classified as American Society of
Anesthesiologists [ASA] physical status I-Ⅱ) undergoing elective
repair of unilateral inguinal hernia during sevoflurane general
3
Department of Anesthesiology and Health statistics,Mianyang Central Hospital,Sichuan,China.
Correspondence: Xiu Ze LI,Department of Anesthesiology,Mianyang Central
Hospital,Sichuan,China. e-mail:[email protected]
anaesthesia were enrolled in the study in Mianyang Central
Hospital.Patients were excluded if with known allergy to any of the
medications used,serious cardiovascular system disease,liver or kidney
dysfunction,neurologic disease,a history of long-term therapeutic
administration of analgesics,peptic ulceration,bleeding disorders,body
weight less than 10 kg or greater than 30 kg were also excluded.
All children fasted for 6h,forbidden to drink 4h
preoperatively.before surgery,cream was was used to the back of the
hand to alleviate the pain of the insertion of an i.v.cannula.Each
child received an intraverous midazolam 0.1 mg/kg 5 minutes before
entering into the operating room.The monitoring system include pulse
oximetry,noninvasive arterial pressure and
electrocardiography.Subjects were randomly allocated to one of two
groups using a computer-generated random number assignment,sufentanil
group(S,n = 40)and fentanyl group(F,n = 40). Anaesthesia was induced
with 8 vol% sevoflurane in 100% oxygen via face mask without
neuromuscular blocking agents.After achieving adequate depth of
anesthesia,as evidenced by the tolerance of laryngoscopy,a laryngeal
mask airway(LMA) was inserted under direct laryngoscopy for airway
maintenance,pressure-controlled ventilation was adapted to maintain
4
Department of Anesthesiology and Health statistics,Mianyang Central Hospital,Sichuan,China.
Correspondence: Xiu Ze LI,Department of Anesthesiology,Mianyang Central
Hospital,Sichuan,China. e-mail:[email protected]
end-tidal CO2 levels between 35 and 45 mmHg.Intraverous ketorolac 0.5
mg/kg was administered to each child immediately after induction of
anesthesia for the control of postoperative pain.Just before skin
incision the patients received sufentanil 0.15 ug/kg in group S and
fentanyl 1.5 ug/kg in group F intravenously,anaesthesia was maintained
with 3-5 vol% sevoflurane in oxygen without N2O.The sevoflurane
concentration during surgery was controlled according to the
haemodynamics of each children maintaining systolic arterial
pressure,heart rate,or both changes within 30% of baseline,fentanyl 1
ug/kg was given to children in both groups for an increase in heart
rate or systolic blood pressure 30% above preincision values that
continued for 5 minutes.At the end of surgery the anesthetic was
discontinued and the children were ventilated with 100% O2.When the
patients were in a state of deep level of anesthesia,but recovering
adequate spontaneous ventilation(VT›8 ml/kg,respiratory rate›16
breaths /min),the LMA was removed and the oropharynx was gently
suctioned under direct laryngoscopy,the children were transferred to
post-anaesthetic care unit(PACU).
Postoperative agitation scores were evaluated by the same PACU nurse
who was unaware of the group into which the child was divided until
5
Department of Anesthesiology and Health statistics,Mianyang Central Hospital,Sichuan,China.
Correspondence: Xiu Ze LI,Department of Anesthesiology,Mianyang Central
Hospital,Sichuan,China. e-mail:[email protected]
all children were quiet.The paediatric anaesthesia emergence delirium
(PAED)scale(table 1) was used to evaluate EA（7）,and the highest
scores were recorded.A four-point scale was also used to investigate
the incidence of EA:agitation score was graded 1 if the child was
calm;2 if the child was not calm but could be easily consoled;3 if the
child was moderately agitated or restless and not easily calmed;and 4
if the child was combative,excited,or disoriented（8）.Scores 1 and 2
were regarded as non-behavioral change,and scores 3 and 4 to indicate
EA and the children received an intravenous rescue fentanyl 1
ug/kg.Number of patients who received additional fentanyl during
surgery and postoperative rescue fentanyl at the PACU were
recorded.The duration of surgery,time of anesthesia (from the start of
induction till removal of LMA),emergence time(time to the first
response to a verbal command following discontinuation of
sevoflurane)and total time in the PACU were recorded.Heart rate and
blood pressure ,as well as the incidence of adverse events such as
vomiting,laryngospasm,oxygen desaturation (peripheral oxygen
saturation on pulse oximetry less than 95%) and pruritus during PACU
were also noted.Children were discharged from the PACU to general ward
when hemodynamic stability,full awake and no pain or vomiting.
6
Department of Anesthesiology and Health statistics,Mianyang Central Hospital,Sichuan,China.
Correspondence: Xiu Ze LI,Department of Anesthesiology,Mianyang Central
Hospital,Sichuan,China. e-mail:[email protected]
Assuming an incidence of postoperative agitation of 50% or more
supplementing sevoflurane with fentanyl was previously reported(2),
and a 50% reduction in EA was considered to be clinically
significant,we calculated that 40 patients were required in each group
(for a level of significance of 0.05 and a power of 0.80).Quantitative
variables were described as mean and SD,qualitative variables were
described as number and percentage,chi-square test was used to compare
qualitative variables between groups,fisher exact test was used
instead of chi-square when one expected cell or more less than or
equal to 5.Independent-Samples t-test was used to compare two groups
as regards to quantitative variables.A P-value less than 0.05 was
considered to be statistically significant.
Results
A total of 80 children were enrolled in this study(n = 40 in the
sufentanil group and n = 40 in the fentanyl group).There were no
significant differences between the two groups with respect to
age,weight,gender,ASA physical status,duration of surgery or duration
of anesthesia.(table 2).
The mean scores of the PAED scale and the incidence of emergence
agitation were significantly lower in the sufentanil group as compared
7
Department of Anesthesiology and Health statistics,Mianyang Central Hospital,Sichuan,China.
Correspondence: Xiu Ze LI,Department of Anesthesiology,Mianyang Central
Hospital,Sichuan,China. e-mail:[email protected]
with those in the fentanyl group(P = 0.001 and P = 0.039
respectively),There were no significant differences between the two
groups in terms of emergence time and during stay in PACU(table 3).
Number of children who received additional fentanyl during surgery
were significantly lower in sufentanil group compared to fentanyl
group(p = 0.043) and significantly fewer patients in the sufentanil
group received 1 dose of postoperative rescue fentanyl at the PACU
compared to the fentanyl group(p = 0.015) as shown in Table 4.
A comparison of postoperative adverse events between the two groups
is presented in table 5.The incidence of vomiting was significantly
higher in the fentanyl group than in the sufentanil group (p =
0.023).There were no differences between the two groups in terms of
the incidence of laryngospasm,oxygen desaturation or pruritus.
Discussion
All children completed the present experiment,and all the patients get
good ventilation,its possible reason is that we place LMA into the
correct position under direct laryngoscopy.
In recent years,sevoflurane has been widely used in children for
general anesthesia induction and maintenance because of its low bloodgas solubility and blood-tissue solubility,but EA is a common and
8
Department of Anesthesiology and Health statistics,Mianyang Central Hospital,Sichuan,China.
Correspondence: Xiu Ze LI,Department of Anesthesiology,Mianyang Central
Hospital,Sichuan,China. e-mail:[email protected]
difficult to deal with problems faced by the pediatric
anesthesiologists,with a incidence up to 80%(9),and it is potentially
dangerous to the child,such as falling out of bed,the removal of the
surgical dressings,intravenous catheters and so on.Additional care may
need when children are excited.Their parents are often worried when
seeing their children restlessness.The otorhinolaryngologic
surgeries,post-operative pain,young age,pre-operative anxiety,and
adjustment disorder of patients are risk factors for EA(10).
The present study demonstrated that administration of IV a single
dose of 0.15 ug/kg sufentanil compared with 1.5 ug/kg fentanyl just
before skin incision significantly reduced postoperative agitation
after sevoflurane anesthesia in preschool children undergoing elective
repair of unilateral inguinal hernia,We also found that significantly
fewer children in the sufentanil group received additional fentanyl
during surgery and significantly fewer children in the sufentanil
group received 1 dose of postoperative rescue fentanyl at the PACU
compared to the fentanyl group,thus may reduce the injure to children
caused by EA and decrease the
adverse effects brought by supplemental
fentanyl.
Many studies have shown that EA in pediatric anesthesia is related
9
Department of Anesthesiology and Health statistics,Mianyang Central Hospital,Sichuan,China.
Correspondence: Xiu Ze LI,Department of Anesthesiology,Mianyang Central
Hospital,Sichuan,China. e-mail:[email protected]
to preoperative anxiety of the children（11-13）,in order to relieve
the emotional stress in children before surgery,premedication with an
intraverous midazolam 0.1 mg/kg was given before separating from their
parents in this study,rather than oral midazolam in the majority of
studies,because the former is rapid onset of action.Type of surgery is
also a predisposing factor of EA(14),all children receiving the same
type surgery and all surgery was performed by the same surgeon in the
present study so as to get rid of the effect of surgery on EA.Airway
irritation reactions caused by tracheal intubation may lead to
emergence behavior change,including EA(15).The present study used LMA
for control ventilation and pull out it while in a deeply
anaesthetized state to avoid the effect of airway irritation on EA.
Study has suggested that rapid recovery of sevoflurane from general
anesthesia may trigger EA(9),However,compared with continuing
sevoflurane for maintenance，recovery from maintenance of anesthesia
with propofol after sevoflurane induction,which is also rapid,is
smoother than recovery from sevoflurane(16).Therefore, Sevofluranerelated emergence agitation is maybe an intrinsic characteristic of
the anaesthetic itself,having different central nervous functions
compared with other inhaled anaesthetics.
10
Department of Anesthesiology and Health statistics,Mianyang Central Hospital,Sichuan,China.
Correspondence: Xiu Ze LI,Department of Anesthesiology,Mianyang Central
Hospital,Sichuan,China. e-mail:[email protected]
Many drugs can reduce the occurrence of postoperative
agitation,propofol,pain prevention,ketamine,and a2-AR agonists are
effective against EA（4）.
Postoperative pain is one of the most important factors leading to
EA,there were many studies that had confirmed a decrease of EA with
the use of fentanyl(4,6,17,18).The frequency of severe agitation of
the present study is inconsistent with the results of another study
investigating the prophylactic effects of fentanyl on EA(2),however
LMA was used for airway maintenance and removed it while in a deeply
anaesthetized state in this study,but tracheal intubation was
performed in that study.Also, intraverous ketorolac was administered
to child for the control of postoperative pain in the present
study,but there was no analgesic for the control of postoperative
pain.
Just as fentanyl,sufentanil is also a pure µ agonist,but it is
approximately ten times as potent as fentanyl in human(19)and produce
less and shorter-lasting respiratory depression than fentanyl(20),so
we studied the effect of 0.15 ug/kg sufentanil on EA and compared it
with 1.5 ug/kg fentanyl.The mean PAED scores and the incidence of
severe agitation were significantly lower in the sufentanil group
11
Department of Anesthesiology and Health statistics,Mianyang Central Hospital,Sichuan,China.
Correspondence: Xiu Ze LI,Department of Anesthesiology,Mianyang Central
Hospital,Sichuan,China. e-mail:[email protected]
compared with the fentanyl group,this is probably because it can
produce longer lasting analgesia(19) and is more lipophilic than
fentanyl(21),will allow the drug to penetrate the blood-brain barrier
rapidly,resulting in sufficient sedation effect with low-dose(22).We
speculate that the likely reason of significantly fewer children in
the sufentanil group received additional fentanyl during surgery is
that the duration of the analgesic effect of sufentanil is longer than
that of fentanyl.Opioids can lead to postoperative nausea and
vomiting, the incidence of vomiting was significantly higher in the
fentanyl group than that in the sufentanil group,this is probably due
to a reduction in children exposure to postoperative rescue fentanyl.
EA may also occur in the case of adequate treatment of pain or even
no pain (23,24).In addition,according to a meta-analysis,there are no
correlation of the efficacy of ketamine,a2-agonists,or fentanyl in
postoperative pain relief and EA decreasing(4).These results suggest
that the analgesic properties are not alone involved in their
prevention of
EA,other properties such as sedation effect may play a
role against EA,because sufentanil is more lipophilic than
fentanyl,will allow the drug to penetrate the blood-brain barrier
rapidly,resulting in sufficient sedation effect,and the incidence of
12
Department of Anesthesiology and Health statistics,Mianyang Central Hospital,Sichuan,China.
Correspondence: Xiu Ze LI,Department of Anesthesiology,Mianyang Central
Hospital,Sichuan,China. e-mail:[email protected]
agitation were significantly lower in the sufentanil group compared
with the fentanyl group.The protective effect of fentanyl on EA may be
through the hypocretin system,because opioids can directly or
indirectly inhibit the hypocretin system(25).
As we worry about additional sufentanil may resulted in delayed
recovery,additional fentanyl was given to children during surgery or
at the PACU,instead of giving sufentanil.
In the present study we did not compare the pain score between the
two groups because we focused on the effects of sufentanil on EA in
preschool patients undergoing sevoflurane anesthesia.Another
limitation of our study is the absence of a placebo-controlled group
because of the rejection by our Hospital Ethics Committee.Futher
studies are needed to find the optimal dose of sufentanil for
prevention of EA in inguinal hernia repair pediatric sevoflurane
anesthesia and the extent to which reducing postoperative agitation
when additional sufentanil rather than fentanyl was given to children
or sufentanil was given to children at the end of surgery,instead of
skin incision.
Conclusion
In summary,this study demonstrateds that the intravenous
13
Department of Anesthesiology and Health statistics,Mianyang Central Hospital,Sichuan,China.
Correspondence: Xiu Ze LI,Department of Anesthesiology,Mianyang Central
Hospital,Sichuan,China. e-mail:[email protected]
administration of a single dose of 0.15 ug/kg sufentanil just before
skin incision decrease significantly the incidence of EA and does not
lengthen discharge time from the PACU in children undergoing inguinal
hernia repair under sevoflurane anesthesia compared with a single dose
of 1.5 ug/kg fentanyl.
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1. Delgado-Herrera L,Ostroff RD,Rogers SA.Sevoflurance:approaching the
ideal inhalational anesthetic.a pharmacologic,pharmacoeconomic,and
clinical review.CNS Drug Rev 2001;7(1):48-120
2. Aouad MT,Kanazi GE,Siddik-Sayyid SM et al.Preoperative caudal block
prevents emergence agitation in children following sevoflurane
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3. Davis PG,Greenberg A,Gendelman M et al.Recovery characteristics of
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insertion.Anesth Analg 1999;88:34—8.
4. Dahmani1 S,Stany1 C,Brasher1 C et al.Pharmacological prevention of
sevoflurane-and desflurane-related emergence agitation in children:a
meta-analysis of published studies.
14
Department of Anesthesiology and Health statistics,Mianyang Central Hospital,Sichuan,China.
Correspondence: Xiu Ze LI,Department of Anesthesiology,Mianyang Central
Hospital,Sichuan,China. e-mail:[email protected]
Br J Anaesth 2010;104:216-23.
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and fentanyl on emergence characteristics after adenoidectomy in
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8. Welborn LG,Hannallah RS,Norden JM et al.Comparison of emergence and
recovery characteristics of sevoflurane,desflurane,and halothane in
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in children.Curr Opin Anaesthesiol 2001;14:339-343.
11. Kim YH,Yoon SZ,Lim HJ,et al.Prophylactic use of midazolam or
15
Department of Anesthesiology and Health statistics,Mianyang Central Hospital,Sichuan,China.
Correspondence: Xiu Ze LI,Department of Anesthesiology,Mianyang Central
Hospital,Sichuan,China. e-mail:[email protected]
propofol at the end of surgery may reduce the incidence of emergence
agitation after sevoflurane anaesthesia.Anaesth Intensive Care
2011;39:904-8.
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high incidence of problematic behavior on emergence after halothane
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13. Arai YC,Ueda W,Ito H et al.Maternal heart rate variability just
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undergoing
general
anesthesia.
Paediatr
Anaesth
2008
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15 .Lee YC,Kim JM,Ko HB et al.Use of laryngeal mask airway and its
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sevoflurane
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explain agitation following sevoflurane anaesthesia in infants and
children:a comparision with propofol.Paediatr Anaesth 2003;13:63-7.
16
Department of Anesthesiology and Health statistics,Mianyang Central Hospital,Sichuan,China.
Correspondence: Xiu Ze LI,Department of Anesthesiology,Mianyang Central
Hospital,Sichuan,China. e-mail:[email protected]
17.
Cohen
IT,Hannallah
RS,Hummer
KA.The
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on emergence agitation and quality of life in patients with moderate
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23. Graero J,Surgenor S,Whalen K.Emergence agitation in paediatric
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17
Department of Anesthesiology and Health statistics,Mianyang Central Hospital,Sichuan,China.
Correspondence: Xiu Ze LI,Department of Anesthesiology,Mianyang Central
Hospital,Sichuan,China. e-mail:[email protected]
24. Cravero JP,Beach M,Thyr B et al.The effect of small dose fentanyl
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Table 1
The paediatric anaesthesia emergence delirium (PAED)scale
Score1
the child makes eye contact with the
caregiver
Score2
the child shows purposeful actions
Score3
the child is aware of
his or her
surroundings
18
Department of Anesthesiology and Health statistics,Mianyang Central Hospital,Sichuan,China.
Correspondence: Xiu Ze LI,Department of Anesthesiology,Mianyang Central
Hospital,Sichuan,China. e-mail:[email protected]
Score4
the child is restless
Score5
the child is inconsolable
Items1-3
are
reversed
scored
as
follows:4,not
at
all;3,just
a
little;2,quite a bit;1,very much;and 0,extremely.Items (4)and(5) are
scored as follows:0,not at all;1,just a little;2,quite a bit;3,very
much;and 4,extremely.The score for each item was summed to obtain a
total PAED scale score.
Table 2
Demographic data,surgical and anesthetic times
group F
group S
Age(year)
3.5 ± 1.2
3.4 ± 1.3
Weight(kg)
15.1 ± 8.9
16.2 ± 9.7
Gender(male/female)
33/7
32/8
ASA Ⅰ/Ⅱ
35/5
36/4
surgery duration(min)
45.6 ± 13.3
43.9 ± 16.5
anesthesia duration(min)
61.2 ± 15.8
63.4 ± 17.1
Data are mean±SD or numbers of patients,there was no difference in
variables between the two groups.
Table 3
Postoperative agitation scores,recovery time
19
Department of Anesthesiology and Health statistics,Mianyang Central Hospital,Sichuan,China.
Correspondence: Xiu Ze LI,Department of Anesthesiology,Mianyang Central
Hospital,Sichuan,China. e-mail:[email protected]
Group F
group S
p
PAED scale score
12 ± 3.8
9.1 ± 3.5
0.001
Incidence of agitation
20(50%)
11(27.5%)
0.039
emergence time(min)
15.05 ± 3.19
16.13 ± 3.65
0.165
PACU time(min)
29.83 ± 6.43
27.9 ± 8.45
0.255
The mean scores of the PAED scale and the incidence of severe
emergence agitation were significantly lower in the sufentanil group
compared with the fentanyl group.
Table 4
Number of patients(%) received fentanyl
group F
additional fentanyl during surgery:
8（20%）
group S
2（5%）
p
0.043
postoperative rescue fentanyl:
1dose
More than 1 doses
17(42.5%)
3(7.5%)
7(17.5%)
4(10%)
0.015
1.0
Number of patients received additional fentanyl during surgery and 1
dose of postoperative rescue fentanyl at PACU were significantly lower
in sufentanil group compared to fentanyl group.
20
Department of Anesthesiology and Health statistics,Mianyang Central Hospital,Sichuan,China.
Correspondence: Xiu Ze LI,Department of Anesthesiology,Mianyang Central
Hospital,Sichuan,China. e-mail:[email protected]
Table 5
Incidence of side effects
No.group F (%)
No.group S(%)
p
vomiting
9（22.5%）
2（5%）
0.023
laryngospasm
1(2.5%)
0
1.0
oxygen desaturation
3(7.5%)
1(2.5%)
0.608
pruritus
2(5%)
4(10%)
0.671
The incidence of vomiting was significantly higher in the fentanyl
group than in the sufentanil group
21
Department of Anesthesiology and Health statistics,Mianyang Central Hospital,Sichuan,China.
Correspondence: Xiu Ze LI,Department of Anesthesiology,Mianyang Central
Hospital,Sichuan,China. e-mail:[email protected]