Poot ap nausea and vomiting have great incidence specially in

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EL-MINIA MED., BULL., VOL. 18, NO. 2, JUNE, 2007
Shaban
TRIPLE ANTIEMETIC THERAPY IN HIGH RISK FEMALE IN
PREVENTION POSTOPERATIVE NAUSEA AND VOMITING
By
Mohamed Shaban M. MD.
Department of Anesthesia & ICU, Minia Faculty of Medicine
ABSTRACT:
Background: Postoperative nausea and vomiting (PONV) have great incidence
especially in female patients undergoing gynaecological laparoscopy. Also
irregularities in menstrual cycle influence and increase the incidence of post operative
nausea and vomiting. Triple therapy was preferred to be in practice for preventing
post operative nausea and vomiting.
Aim of the study: to evaluate the effects of Triple therapy on prevention of
postoperative nausea and vomiting in high risk female with irregular menstrual cycle
undergoing laparoscopy
Patients and methods: 120 female patients are scheduled for undergoing laparoscopy
are allocated into a prospective observational study divided according to regularity of
menstrual cycle into two large groups which is further divided accordingly to the
application of Triple therapy for prevention of post laparoscopic nausea and vomiting.
Anaesthetic and post operative analgesia were consistent for all 4 groups .
Anaesthetist and icu nurses, observers are blind as regards menstrual cycles and
medications given, all patients were operated by the same surgeon also all groups
were comparable as regards, age, weight, ASA, duration of surgical procedure .
Group (1): patients has regular menstruation cycle history and not received Triple
antiemetic Therapy 10 ml saline given iv just before induction. Group (II): patients
have irregular menstrual history and did not receive antiemetic therapy, only 10 ml
normal saline given intravenously before induction of anesthesia. Group (III): patient
has regular menstrual cycle history and received Triple antiemetic therapy. Group
(IV): patients have irregular menstrual history and received triple antiemetic therapy.
postoperative nausea & vomiting as side effects are recorded also severity of PONV
also recorded and during 24 hours post operative in ICU stay. Triple therapy with
granisetron (1mg) plus dexamethazone (8mg) and droperidol (0.6 25 mg immediately
before induction diluted up to 10 ml with normal saline.
Results: as nausea and vomiting are separately analysed, there was statistically
significant difference between group 1 (regular menstrual cycle) and group II
(irregular menstrual cycle) as regards incidence of nausea and vomiting respectively
which was (60% and 50%) and (20% and 10%) for nausea and vomiting in group II
and group I with p < 0.01 for both ,also the incidence of severe and moderate was
30% in group II versus 10% in group I with P< 0.09 also incidence of post operative
nausea was significantly reduced to only 10% and 3.3% in group IV versus to 6.6%
and 3.3% in group III with p≤0.01 for both nausea and vomiting when compared to
placebo group II and I respectively as regards side effects only some of headache,
drowsiness, dizziness and muscle pain were noticed in group III and IV without
significant effects. Antiemetic administration was more in group II than in group I
with significant difference p ≤ 0.01 also these was no anti emetic administration as in
group III and IV p ≤ 0.001 .
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EL-MINIA MED., BULL., VOL. 18, NO. 2, JUNE, 2007
Shaban
Conclusion: laparoscopic female patient with history of irregular menstrual history
must be considered as highly risky patient for postoperative nausea and vomiting and
managed accordingly by Triple antemetic therapy prophylacticaly.
KEY WORDS:
Female
PONV
Irregular menses
Triple therapy.
INTRODUCTION:
Post operative nausea and
vomiting (PONV) is common in
women of child bearing age and is a
major
cause
of
postoperative
morbidity1-4. It may prolong recovery
time, delay patient discharge and
increase hospital costs .Gender is an
important factor for post operative
nausea and vomiting. The incidence of
PONV is two to three times higher in
female than males3. Fluctuation in
female sex hormones concentration
during menstrual cycle leads to
variation in the incidence of PONV in
females5,6,7. As female approach
menarche. The incidence of vomiting
in post menopausal females is similar
to that of men suggesting a major
hormonal influence7,8. Laparoscopic
surgery is associated with higher
incidence of PONV (40–77%)8. PONV
may be associated with serious complications such as wound dehiscence,
pulmonary aspiration of gastric
content9. persistent or severe nausea
and vomiting can result in dehydration,
electrlyte imbalance, delayed hospital
discharge or unanticipated hospital
admission after ambulatory surgery
and patients with persistent PONV
continue to be at risk for these
symptoms 24 hours postoperatively10.
Since The etiology of PONV is
multifactorial with at least four
different neurotransmitters implicated
in their etiology, no single anti emetic
drug possess the ability to prevent
PONV in all patient population11,12.
Therefore, combination of anti emetic
Laparoscopy
therapy using drugs that act at different
neuroeceptor sites has been re
commended for the at risk patients11.
Granisetron is a new antiemetic drug
its precise mechanism is not known but
it has been suggested. That it may act
on sites containing 5- hydroxy
tryptamine type 3 (5Ht3) receptor with
antiemetic effects13. Dexamethazone
has been shown to be an effective
antiemetic13 although its mechanism
still unclear it may act through
prostaglandin antagonism, serotonin
inhibition in the gut, anti inflammatory
and or membrane stabilizing effects14.
Droperidol has been proven to be an
excellent anti emetic anti psychotic
drug, its antiemetic and anti psychotic
properties are derived from its potent
dopamine receptor (D2) antagonism15.
So I designed a study to test the effects
that Triple antiemetic therapy with
granisetron,
dexamethazone
and
droperidol on prevention of P.O.N.V
but in highly risky female patients
undergoing laparoscopy.
PATIENTS AND METHODS:
120 female patients were
included in a prospective blind
observational study after getting
approval of local ethic committee, and
obtained informed written consent,
patients are only female with ASA I, II
physical status, aged 18-35 years old
who were undergoing laparoscopy for
investigations of infertility or moderate
laparoscopic surgical interference,
menstrual history is taken, rythm of
cycle is also asked whether regular or
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EL-MINIA MED., BULL., VOL. 18, NO. 2, JUNE, 2007
irregular, The day time of the cycle on
which the surgery took place was
calculated from the first day of the last
menstrual cycle.
Shaban
maintained with 2-3% sevoflurane
(inspired
concentration),
100%
oxygen, maintain mean arterial blood
pressure and pulse rate within 20% of
the base line, muscle relaxation was
maintained, mechanical ventilation was
adjusted to maintain end Tidal CO2 at
(30 – 35 mm Hg), nasogastric suction
was applied before extubation and post
extubation reversal of relaxation by
atropine 0.01mg/kg and prostigmin
0.04 mg /kg .Then aldurte recovery
score was used to discharge patient
from PACU with total score of 1016.
Postoperatively: patient shifted to
I.C.U for further monitoring for 24
hours. E.C.G monitoring, dysryhthemia, headache and other side effects
e.g sleepness, excessive sedation,
drowsiness, others, anesthesia time
(from induction of anaesthesia to
discontinuation of sevoflurane. Surgery
time from skin incision to skin closure.
Stay time in PACU: analgesia was
given 1 ug/kg fentanyl iv 50 mg diclofenac suppository every 8 hours, all
episode of postoperative nausea and
vomiting were recorded every one hour
for 24 h by I.C.U doctors and staff
nurses. Vomiting is defined by forceful
expulsion of gastric contents from the
month. Nausea is defined as unpleasant
sensation associated with awarness of
the urge to vomit. Retching was
defined
as
labored,
spasmodic
rhythmic movement. 10mg metoclopramide iv is given if there is two or
more episodes of PONV occurred
during the postoperative 24 hours, also
side effects are also recorded,
postoperative analgesia prescribed in
the form of 1 ug/kg fentanyl and
diclofenac 50 mg every 8 hours and on
request also recorded. Nausea are
classified as none, mild, moderate3-5 a
severe, vomiting is also classifiedby
the number of episodes into non (0),
mild1-2,
moderate3-5,
or
severe
13,14,15
(>5)
.
Patient are excluded if there is
GIT, renal, hepatic cardiac diseases,
dysrrhythmia, antiemetic therapy,
obese patient, history of motion
sickness, amenorrhea or smoking or
incomplete medical records pregnant,
or breast feeding, electrolyte imbalance, patient also with preoperative
nausea and vomiting are also excluded
from study. All patients are operated
by the same surgeon and anaesthetized
by the same anaesthesia team and
technique; patients are divided according to regularity of menstrual cycle
and antiemetic therapy for prevention
PONV into four groups. Group I: 30
female patients with regular menstrual
cycle and not receiving antiemetic
Therapy (group I R e out) only 10 ml
salime (placebo). Group II: 30 female
patients with irregular menstrual cycle
also without antiemetic Therapy (10ml
saline) (Placebo). Group III: 30 female
patients with regular menstrual history
but receiving Triple antiemetic therapy
in the form of granisetron (1mg),
dexamethozone 8 mg, droperidole
(0.625) mg given intravenously just
before induction. Group IV: 30 female
patient with irregular menstrual history
received Triple antiemetic as in group
IV (10 ml volume). The drugs were
administered by slow intravenous
injection and prepared in the pharmacy
by person not involved in the study in
identical syringes containing the study
drugs which were diluted with normal
saline to achieve a volume of 10 ml.
No pre anaesthetic medication given
also anaesthetists were not aware of
which treatment is given. Anaesthesia
was induced by 2.5 mg/kg propofol
and 2 ug/kg. Fentanyl, atracurium 0.5
mg/kg was administered to facilitate
tracheal intubation, anaesthesia was
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EL-MINIA MED., BULL., VOL. 18, NO. 2, JUNE, 2007
Statistical analysis: of data among the
treatment groups was performed by
ANOVA test with Bon ferroni correction
for multiple comparisons x2 test or
Shaban
fisher exact probability test as
appropriate p value < 0.05 was
considered significant. ALL values are
expressed as mean + SD or number (%).
Table (1): Patients characteristic, operative and opioid requirements over 24 h.
(mean± SD ) a number
Age
Wt
ASA
I/II
Duration of
surgery
Fent./ug.
Group 1 n=30 G II
n=30
Regular.
Irregular
Mens cycle
Mens. Cycle
25 ± 7
28±3
86.2±7.6
67.1+8.5
14/16
16/14
G III n=30
regular +
Triple
27±4
65.1±6.1
15/15
G IV n=30
irregular +
triple Th
22±2
66.1±7.1
17/13
40.1 ± 5.1
45.1±6.1
43.1±7.1
44.2±8.1
250±50
260±40
250±40
70±50
P > 0.05 NS between all form groups
Triple therapy= Triple anti emetic therapy
Regular = regular menstrual history
Table 2: Number of patients with PONV, expressed in % and doses of metoclopramide
Rescue in four groups in 24 hours .
Placebo
I
+ (6) 20%
Incidence of nausea
+ 4 (13.3%)
Incidence of vomiting
+ 10 %
Incidence of moderate
and sever N& V.
Metoclopramid used mg + 100 ±20
+ p >0.01
I , IV
II
18 60%x
15 50 %
30% x
Triple therapy
III
IV
* 6.6 %
** 6.6 %
* 3.3 %
** 3.3 %
0%*
0 %**
150±30 x
(x) p >0.01
II, I
30±10 *
*P >0.01
III , I
**20±10
**p>0.01
IV & II
dence nausea and vomiting episodes
were high in group II (60 % and 50%)
that of group 1 (20% and 13.3%)
respectively with P < 0.01 for both
incidence which mean that the incidence of PONV are much in patients
having irregular menstrual history than
in patient with regular menstrual
history.
RESULTS:
The study groups were
comparable as regard the patients
characteristics, duration of surgery and
duration of anesthesia (Table 1). Vital
signs of patients were maintained in
the normal range and oxygen
saturation did not decrease below 95%
during the surgeries. As regards inci-
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EL-MINIA MED., BULL., VOL. 18, NO. 2, JUNE, 2007
In addition of incidence there
was significant difference in the
severity of PONV. There was more
severe and moderate episodes in group
II (30%) versus 10% in group I with P
< 0.05 .Also the incidence of PONV
was significantly reduced to only
(6.6% and 3.3%) in group IV versus to
(6.6% and 3.3%) in group III without
significant difference p > 0.05 for both
nausea and vomiting also there was
significant difference between group II
and group IV also between group I and
group III as regards incidence of
PONV. with P < 0.05. As regards
antiemetic therapy given post operatively was significantly more in group
II than in group I with P < 0.05
provided. There was no post operative
antiemetic treatment in group IV with
high significant difference P < 0.001.
There were some side effects were
noticed in group III and IV in the form
of headache, Drowsiness, Dizziness
and muscle pain without significant
effects. Post operative analgesia was
significantly less in group IV (50±20)
than in group III (120 ± 30) then in
group I (260±30). Then in group II
(280 ± 40) ug fentanyl with P <0.01
between group IV and group III, and
group IV and group I without
significant difference between group I
and group II P > 0.05.
Shaban
adult males also the severity of
vomiting was greater than in males
20/17. Rita et al., showed higher rates
of emesis in older children as women
approach menopause the incidence
decrease approaching that of men7 this
means that fluctuation of female sex
hormone concentration during menstrual cycle may increase the incidence
of PONV. Pataky et al., demonstrated
that lower incidence of PONV in
patient undergoing dilatation and
curettage than those undergoing laparoscopy and ovum retrieval also the
former have low level of hormones6.
Also there was a correlation between
PONV and high plasma oestrogen
level as demonstrated by Pekka
Honkavaara21. Benttie and lindbland
and their colleagues described that
changing concentration of follicular
stimulating hormone (FSH) and/or
oestrogen during menstrual cycle may
sensitize the chemoreceptor trigger
zone and or the vomiting center22,23 As
PONV have a deleterious effects on the
patient out come and satisfaction5-16
multi modal strategy has been developed for managing patient at high risk
for developing PONV is using of less
emetogenic anaesthetic technique, adequate intra venous hydration, effective
pain control and use of combination of
anti emetic is that block different
neuro receptors in the central nervous
system may form an approach to
decrease PONV24,25. In the current
study the results demonstrated that
complete response in groups III and IV
than in group I, II because of effects of
triple anti emetic therapy with
significant difference between group
IV and III in comparison to group I, II
As there was significant more incidence and severe PONV. Also more
use of anti emetic therapy in group II
& I with significant difference between
groups II & I p < 0.01. Some study
results revealed very low incidence of
PONV also higher significantly
DISCUSSION:
Gender is an important factor
for PONV, in my study there was
increased incidence of PONV especially in female patients with irregular
menstrual cycle suggesting that there
was a role for female sex hormones or
other unidentified mechanism for
increased incidence of PONV. My
results showed increased incidence and
severity of PONV in an irregular
menstrual history patient. This finding
correlate with other studies that
reported that the incidence of PONV in
adult females was 2-3 times that in
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EL-MINIA MED., BULL., VOL. 18, NO. 2, JUNE, 2007
Shaban
(1.25 – 2.5mg) and reported prolonged
sleepness which is not observed in my
study as I used lower droperidol dose
(0.625 mg) which also has a protective
effects against headache35,36 ,37.
(P<0.01) incidence of complete
response in triple therapy managed
group up to 95% which is more than
that not managed by anti emetic
therapy. These results are in accordance with that of Wilson and
others26,27 also
triple anti emetic
therapy was confirmed in systematic
review of studies in which different
anti emetics, were used28,29. My results
are in consistent with that of puero and
his colleagues who reported that
combination of ondansetron (5 HT 3)
antagonist) and droperidol was more
effective than either alone or placebo
in the prevention of PONV in women
undergoing
elective
abdominal
surgery30 also the same results reported
by Fujii et al., who reported the results
in middle ear surgery which are also in
accordance
with
our
results31.
Minegishi et al., concluded through
their study, That addition of droperodol
to granesetron, dexamethazone combination did not augment their antiemetic
effect against chemotherapy induced
emesis32. Also John et al., reported that
electrocardiographic monitoring for all
patients receiving droperidole may be
an overestimation of the risk, and low
risk patient receiving small doses don't
require cardiac monitoring so in
current study I monitored my patients
in ICU and excluded certain clinical
conditions such as electrolyte imbalance, family history suggesting of Q.T
prolonged interval, also any patient
with dyrhythmia a cardiac disease also
we noticed that sedation, drowsiness
dizzness were not serious and this is in
consistence of the results of Fujji and
other investigations who demonstrated
no excessive sedation or extra pyramidal manifestation observed in their
patients undergoing breast surgery and
laparoscopic surgery who treated by
combination of droperidol plus
ondansetron33,34. In contrast to my
results minegishi et al., and Desilva et
al., studied droperidol in high dose and
Conclusion:
Laparoscopic female patient
with history of irregular menstrual
history must be considered as highly
risky patient for postoperative nausea
and vomiting and managed accordingly
by Triple ant emetic therapy
prophylacticaly.
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‫‪EL-MINIA MED., BULL., VOL. 18, NO. 2, JUNE, 2007‬‬
‫وقاية المريضات من القئ والغثيان‬
‫محمد شعبان‬
‫قسم التخدير – كلية طب المنيا‬
‫نظرا ً لكثرة اآلثار المترتبة على الئىو لاليثنىال على اىمة المرندىة بمىي المملنىا ى ل‬
‫لقانة المرندا مل خطرهما ما نتم عىل طرنىح مئىل المرندىة ا كثىر عردىة للئىو لاليثنىال‬
‫بخلنط ثالث مل مثبطا لهما لبناء عل ذلك تم إعياي هذه اليراسة التراقبنة عل ‪ 120‬مرندة‬
‫إل مجملعا أربع عل أسىا ا كثىر عردىة لهىل ممىل لهىم تىارن ننىر منىتظم ى الىيلرة‬
‫الشهرنة ‪.‬‬
‫ المجملعة ا لل ‪ :‬عييها ‪ 30‬مرندة لنمتازلل بتارن منتظم لليلرة الشىهرنة‬‫لتم عالجهم بممللل الملح (بالسنبل) ‪ 10‬سم ممللل الملح قبل التخينر‪.‬‬
‫ المجملعة الثاننة‪ :‬لعييها ‪ 30‬مرندة لال نمتازلل بانتظام اليلرة الشهرنة‬‫رنم عالجهم ب ‪ 10‬سم ممللل ملح قبل التخينر ‪.‬‬
‫ المجملعة الثالثة‪ :‬لعييها ‪ 30‬مرندة ثل المجملعة ا لل لتم عالجهم بخلنط‬‫لنتكىىلل مىىل ‪ 3‬عئىىارا بلاقىىع جراننسىىتلل ‪1‬مىىم لعئىىار الىىيرلبنرليلل ‪50625‬مجىىم‬
‫لعئار الي كسامنتازلل ‪ 8‬مجم بلاقع ‪ 10‬سم قبل التخينر‪.‬‬
‫ المجملع ىة الرابمىىة‪ :‬له ى نو ى خىىلاع المجملعىىو الثاننىىة لتىىم عالجهمىىا مثىىل‬‫المجملع ىة الثالثىىة‪ .‬ل ى أثنىىاء المراقبىىة لمىىية ‪ 24‬سىىاعة بمىىي المملنىىة بالمنظىىار بالمنانىىة‬
‫المركىىزة تىىم تسىىجنل ممىىيال اليثنىىال لالئىىو لشىىيتها المتلسىىطة لالئلنىىة لكىىذلك ممىىيل‬
‫اسىىىتخيام مثبطىىىا الئىىىو لاليثنىىىال بمىىىي الجرامىىىة لكىىىذلك تسىىىجنل أى أثىىىار جانبنىىىة ىىى‬
‫المجملعا ا ربمة تم إجراء عملنا المنظار لجمنع المرد عل ني جراح لامي مع‬
‫عيم المالمظة لالمتابمة با يلنة المستخيمة لأظهر نتائج اليراسة اآلتنة‪:‬‬
‫ ‪ -1‬زناية مميال اليثنال لالئو لشيتها بمي المملنة المجملعا التى تمتىاز‬‫بميم انتظام اليلرة الشهرنة ( ذا ميذى اماائ )‪.‬‬
‫ ‪ -2‬انخواض مميال اليثنال لالئو المجملعا الت تم عالجها بالخلنط‬‫المثبط لليثنال لالئو بنسبة كبنرة (ذا ميذى اماائ ) ‪.‬‬
‫ ‪ -3‬زناية استخيام مثبطا اليثنال لالئىو ى المجملعىا التى لىم نسىتخيم بهىا‬‫المجملعو الت تمتاز بميم انتظام اليلرة الشهرنة‬
‫الخلنط الثالث لكان اكثر‬
‫ لمل هذه النتائج نستنتج أل‪:‬‬‫ ‪ -1‬المرندا تكلل أكثر عردة لليثنال لالئو عملنا المنظار خالاا ً‬‫إذا كل نمتزل بميم انتظام باليلرة الشهرنة (أثار هرملننة) ‪.‬‬
‫ ‪ -2‬كواءة استخيام الخلنط الثالث المسىتخيم باليراسىة ى تخونىن لمنىع اليثنىال‬‫ترة ما بمي المملنة خالاا ً المرندا ا كثر عردة للئو لاليثنال‪.‬‬
‫لالئو‬
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