comparison of ramosetron and ondansetron for preventing post operative nausea and vomiting after...
TRANSCRIPT
COMPARISON OF RAMOSETRON AND ONDANSETRON FOR PREVENTING POST OPERATIVE NAUSEA AND
VOMITING AFTER LAPAROSCOPIC SURGERY
Dr.T.VANITHA D.A POST-GRADUATEDr.T.VANITHA D.A POST-GRADUATE
CO-AUTHORSCO-AUTHORSProf.Dr.N.LATHA M.D.,D.AProf.Dr.N.LATHA M.D.,D.AProf.Dr.B.CHANDRIKA M.D.,D.AProf.Dr.B.CHANDRIKA M.D.,D.AProf.Dr.A.CHANDRASEKARAN M.D.,D.AProf.Dr.A.CHANDRASEKARAN M.D.,D.A
COIMBATORE MEDICAL COLLEGECOIMBATORE MEDICAL COLLEGE
INTRODUCTIONLaparoscopy,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 antihistamines,butyrophenones,dopamine
receptor antagonistsreceptor antagonists) have been investigated for the same but but undesirable adverse effectsundesirable adverse effects such as excessive sedation, hypotension, dry mouth,dysphoria,hallucinations and extrapyramidal symptoms have been noted.
PONV…Ondansetron Ondansetron a selective 5-hydroxytryptamine type
(5-HT3),receptor antagonist reduces the incidence of PONV after laparoscopic surgery.
Ramosetron Ramosetron another new 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 approvalInformed consentTotal No of Pts - 40 ASA physical status I or II Aged between 20-60 yearsScheduled for Laparoscopic Cholecystectomy
and Laparascopic Appendicectomy
MATERIALS AND METHODS
GROUP I
GROUP II
LAP CHOLECYSTECTOMY
9 8
LAP APPENDICECTOMY
11 12
EXCLUSION CRITERIA
History of motion sicknessHistory of previous PONVPregnancy 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 IVAnalgesia : Inj fentanyl 2µg/kg ivInj vecuronium 0.2 mg/kg to facilitate tracheal
intubationMaintenance : 66% N2O and 0.5% -2% isoflurane
in oxygenVentilation 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 extubationReversal with neostigmine 0.04mg/kg iv and
glycopyrrolate 0.01mg/kgTrachea 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-IMEANS.D
31.4612.49
58.86.64
1564.52
7915.06
89.6615
GROUP IIMEANS.D
31.4610.28
557.02
1554.51
7613.65
87.3314.25
STATISTICS[ P VALUE]
0.272 0.560 0.788 0.302 0.430
INCIDENCE OF PONV
NUMBER OFPERSONS-PONVN R V
PERCENTAGE OF PERSONS-PONV N R V
PERCENT OF COMPLETE RESPONSE
GROUP I(RAMOSETRON)
3 2 3 15 10 15 85
GROUP II(ONDANSETRON)
7 2 4 35 10 20 40
NUMBER OF EPISODES
Pt I Pt II Pt III Pt IV
RAMOSETRON RETCHING(2) 1 2
VOMITING(3) 1 1 2
ONDANSETRON RETCHING(2) 1 2
VOMITING(4) 2 1 1 3
ANALYSIS OF TIMING OF PONV
0 to 3 Hrs in % 3 to 24 Hrs in % 24 to 48 Hrs in %
N R V
N R V N R V
G I RAMOSETRON
_ _ _ 13.3 13.33 13.33 13.33 _ 13.33
G II ONDANSETRON
20 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 Not sig
sig sig --- Not sig
COMPARISON IN THE INITIAL 24Hrs
0 to 3 Hrs 3 to 24 Hrs
N R V N R V
RAMOSETRON _ _ _ 13.33% 13.33% 13.33%
ONDANSETRON 20% 6.66% 6.66% 46.66% 13.33% 26.66%
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
SUMMARY40 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
notedNo significant side effects noted in both the groupsComplete response in 48 hours
RAMOSETRON :85%
ONDANSETRON:40%
CONCLUSION
Prophylactic therapy with Ramosetron isRamosetron is more more effectiveeffective 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