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