Transcript Comparison of ramosetron and ondansetron for preventing

COMPARISON OF RAMOSETRON AND ONDANSETRON
FOR PREVENTING POST OPERATIVE NAUSEA AND
VOMITING AFTER LAPAROSCOPIC SURGERY
Dr.T.VANITHA D.A POST-GRADUATE
CO-AUTHORS
Prof.Dr.N.LATHA M.D.,D.A
Prof.Dr.B.CHANDRIKA M.D.,D.A
Prof.Dr.A.CHANDRASEKARAN M.D.,D.A
COIMBATORE MEDICAL COLLEGE
INTRODUCTION
 Laparoscopy,compared to conventional surgery
reduces the patient morbidity significantly.
 PONV increases the duration of hospital stay and
morbidity which negates the advantages of
laparoscopy
 Antiemetic medications which reduces the incidence
of PONV is advantageous
 The two Antiemetics RAMOSETRON and
ONDANSETRON are compared in laparoscopic
procedures
PONV
 PONV are distressing symptoms that often
occur after laparoscopic surgery performed
under GA.
 A number of pharmacologic approaches,
(antihistamines,butyrophenones,dopamine
receptor antagonists) have been investigated
for the same but undesirable adverse effects
such as excessive sedation, hypotension, dry
mouth,dysphoria,hallucinations and
extrapyramidal symptoms have been noted.
PONV…
 Ondansetron a selective 5-hydroxytryptamine type
(5-HT3),receptor antagonist reduces the incidence
of PONV after laparoscopic surgery.
 Ramosetron another new 5-HT3 receptor
antagonist is claimed to be potent with longer
duration of action.
 Hence a comparitive, prospective, randomised,
double blinded study is done.
AIM OF THE STUDY
To evaluate the efficacy and safety of
Ramosetron in preventing PONV after
laparoscopic surgeries with Ondansetron
as the comparative drug.
MATERIALS AND METHODS
 Institutional review board approval
 Informed consent
 Total No of Pts - 40
 ASA physical status I or II
 Aged between 20-60 years
 Scheduled for Laparoscopic Cholecystectomy
and Laparascopic Appendicectomy
MATERIALS AND METHODS
LAP
CHOLECYSTECTOMY
LAP
APPENDICECTOMY
GROUP I
9
11
GROUP II
8
12
EXCLUSION CRITERIA
 History of motion sickness
 History of previous PONV
 Pregnancy
 Menstruating patients
 Antiemetic medication within 24 hours before
surgery.
RANDOMISATION
 Patients were randomly allocated to receive single
dose of one of two treatment regimens (n=20each)
Ramosetron 0.3mg,Ondansetron 4mg
 Administered IV immediately after surgery
 Identical syringes containing each drug was
prepared by personnel not involved in the study.
TECHNIQUE OF GA
 Premed : Inj Glycopyrrolate iv 0.2 mg IM 45 min
before surgery.
 Induction : Inj propofol 2mg/kg IV
 Analgesia : Inj fentanyl 2µg/kg iv
 Inj vecuronium 0.2 mg/kg to facilitate tracheal
intubation
 Maintenance : 66% N2O and 0.5% -2% isoflurane
in oxygen
 Ventilation mechanically controlled
TECHNIQUE OF GA…
 ET CO2 - 35 and 40mmHg
 Muscle relaxation maintained with vecuronium as
required
 Naso gastric tube inserted and suction applied to
empty the stomach before extubation
 Reversal with neostigmine 0.04mg/kg iv and
glycopyrrolate 0.01mg/kg
 Trachea extubated when awake
 Postop analgesia :Inj Diclofenac 6th hourly IM
OBSERVATION
 Observation period : 48 hrs
 Observed for Nausea, Retching, Vomiting
 Episodes of PONV recorded by direct questioning or
by spontaneous complaint by the patient during 3
periods 0-3hrs ,3-24hrs,24-48hrs
OBSERVATION...
 Patients were evaluated for the presence of
nausea, vomiting and retching and number of
episodes of them
 Other side effects: headache, dizziness,drowsiness
noted.
 At the end of each period the patients were
evaluated.
 Complete response is defined as no PONV and no
need for another rescue medication.
RESULTS
DEMOGRAPHIC DETAILS
AGE
WT(KG)
HT(CM)
DUR OF
SUR(MIN)
DUR OF
ANES(MIN)
GROUP-I
MEAN
S.D
31.46
12.49
58.8
6.64
156
4.52
79
15.06
89.66
15
GROUP II
MEAN
S.D
31.46
10.28
55
7.02
155
4.51
76
13.65
87.33
14.25
0.272
0.560
0.788
0.302
0.430
STATISTICS
[ P VALUE]
INCIDENCE OF PONV
NUMBER OF
PERSONS-PONV
N
R
V
PERCENTAGE OF PERSONSPONV
N
R
V
PERCENT
OF
COMPLETE
RESPONSE
3
2
3
15
10
15
85
GROUP II
7
(ONDANSETRON)
2
4
35
10
20
40
GROUP I
(RAMOSETRON)
NUMBER OF EPISODES
Pt I
RAMOSETRON
Pt II
RETCHING(2)
1
2
VOMITING(3)
1
1
ONDANSETRON RETCHING(2)
1
2
VOMITING(4)
2
1
Pt III
Pt IV
2
1
3
ANALYSIS OF TIMING OF PONV
0 to 3 Hrs in %
N
GI
RAM
OSET
RON
_
3 to 24 Hrs in %
R
V
N
R
24 to 48 Hrs in %
V
N
R
V
_
_
13.3 13.33
13.33
13.33
_
13.33
G II
20
OND
ANSE
TRON
6.66
6.66
46.6 13.33
26.66
20
_
13.33
P
value
0.013
0.143
0.032
0.02 1.0
0.048
0.04
0.143 0.142
Signi/
not
signi
sig
---
sig
sig
sig
sig
---
Not
sig
Not sig
COMPARISON IN THE INITIAL 24Hrs
0 to 3 Hrs
RAMOSETRON
3 to 24 Hrs
N
R
V
_
_
_
13.33%
13.33%
13.33%
6.66%
6.66%
46.66%
13.33%
26.66%
ONDANSETRON 20%
N
R
V
DISCUSSION
REVIEW OF LITERATURE
 The reference study is the comparison of
RAMOSETRON and GRANISETRON for preventing
postoperative nausea and vomiting after gynaecologic
surgery.
Yoshitaka Fujii et al
Anesth Analg 1999;89:476-9
 Claimed prophylactic therapy with Ramosetron is
more effective for the longterm prevention of PONV
in major gynaecologic surgery.
DISCUSSION….
 Another study Comparison of RAMOSETRON
and ONDANSETRON for the prevention of
nausea and vomiting after gynaecologic surgery
 Kim et al ,European journal of anaesthesiology june-2006 vol
23,issue p-160
 Claimed the antiemetic efficacyof Ramosetron was
not different from that of Ondansetron
SUMMARY
 40 patients 20 in each group
 Single dose of the drug administered iv
 Observed for a period of 48 hrs
 Number of episodes of retching and vomiting
noted
 No significant side effects noted in both the groups
 Complete response in 48 hours
RAMOSETRON :85%
ONDANSETRON:40%
CONCLUSION
 Prophylactic therapy with Ramosetron is more
effective than with Ondansetron in the initial 24
hours following laparosopic surgery.
 Hence we conclude that RAMOSETRON is more
effective than ONDANSETRON in preventing
PONV after laparoscopic surgeries