Presentation on theme: "COMPARISON OF EFFECT OF ONDANSETRON Vs PALONOSETRON IN PREVENTION OF POST OP NAUSEA AND VOMITING FOLLOWING ENT SURGERIES Dr.Kaviya.K.J II yr MD Prof."— Presentation transcript:
1COMPARISON OF EFFECT OF ONDANSETRON Vs PALONOSETRON IN PREVENTION OF POST OP NAUSEA AND VOMITING FOLLOWING ENT SURGERIESDr.Kaviya.K.J II yr MDProf. Dr. R. Subramaniya Bharathiyar ;Professor and H.O.DProf. Dr. R. Lakshmi, Associate ProfessorProf Dr.Ponnambala Namasivayam, Associate ProfessorDr.Carolin von mullai Assistant professorDept of anesthesiology SMC.Dr.MGR University 2010
2BACKGROUNDPostoperative nausea and vomiting (PONV) “big little problem”is a frequent complication of surgery, which can lead to subject discomfort and dissatisfaction as well as considerable subsequent medical and economic consequences .nausea and vomiting within the 24–72 h period occur with an incidence of approximately 30% and 5% respectively.Gupta et al. found a 32.6% incidence of PDNV.15 In the high-risk patients receiving placebo the incidence of PDNV was approximately 60% in the studies by Kovac et al
3Schematic representation of the factors influencing nausea and vomiting
4Risk Factors: Patient Specific Simplified Scoring SystemFemaleNonsmoking historyHx of motion sickness or PONVUse of postoperative opioidsIncidence of PONVRisk FactorsIncidence10%121%239%361%479%Patients received thiopental for induction, opioid and potent inhalation anesthetic plus nitrous oxide for maintenance. Type of surgical procedure seems to not be an independent risk factor.Apfel CC et al. Anesthesiology 1999;91:
5Chemoreceptor Trigger Zone and Emetic Center AntagonistPromethazine5-HT3 RAsAtropineDroperidolNK-1 RAAgonist5-HT3HistamineMuscarinicDopamine (D2)Substance PReceptor SiteNitrogen mustardCisplatinDigoxin glycosideOpioid, analgesicsVestibular portionof 8th nerveN2OGI tract distensionHigher centers (vision, taste)PharynxChemoreceptorTriggerZone(CTZ)PostremaAreaThe CNS vomiting centers have specific emetogenic receptors.Area postrema is rich in serotonin(5-hydroxytryptamine or 5-HT; a serotonin subtype assoc with nausea and vomiting); opioid; and dopamine D2 receptors.CTZ includes serotonin receptors.Nucleus of the solitary tract has histamine, cholinergic, muscarinic, and enkephalin receptors.Hypotension or pharmacologic stimulants can cause the release of these neurochemicals in the brain, initiating the vomiting reflex.Blockade of these CNS receptors is hypothesized to be the mechanism of action of the commonly used antiemetics.MediastinumParvicellularReticularFormationEmeticCenter?Vagus
6Palonosetron second generation 5-HT3 RA a unique chemical structure. T1/2 40 hrsExhibits high binding affinity.allosteric binding and positive cooperativity,induces receptor internalisationPalonosetron mg IV is approved by FDA (PONV) for up to 24 hours following surgery.SIDE EFFECTS:headache (3%),constipation (2%)prolongation of the QTc interval (5%)
7Rojas et al. described the unique pharmacology of palonosetron compared with other 5-HT3 receptor antagonists,Tang et al. demonstrated a dose response for palonosetron up to 30 μg/kg, with 1 μg/kg being the lowest effective dose in the first 24 h for PONVKovac et al.7 and Candiotti et al. At the highest dose studied (0.075 mg), the incidence of vomiting or need for antiemetic treatment was reduced during the first 24 h after surgery by approximately 20%-30% &found a marked reduction in incidence and severity within the first 24 h .Kovac et al. demonstrated continued efficacy compared with placebo for 24 to 72 h.
8AIM OF THE STUDY Primary Outcome Measures: Secondary Outcome Measures: The purpose of this study is to investigate Iv palonosetron versus Iv ondansetron medication for the prevention of nausea and vomiting through 72 hours postoperatively in patients undergoing ENT procedures requiring general anesthesia.Primary Outcome Measures:proportion of patients with no emetic episodes in the Time Frame: 0-72 hours post-operativelySecondary Outcome Measures:Proportion of patients with no emetic episodes in different time periods :Time Frame: 0-6 hours,6-24 hours,24-72 hours,Severity of nausea in different time periodsTime Frame: 0-6 hours,
9Study design Interventional Single blind Prospective Randomised Non placebo
10PATIENTS AND METHODS:Institutional Ethics Committee approval was obtainedInformed written consent was obtained60 patients belonging to ASA PS 1 &2 undergoing ENT surgeries under general anesthesia were chosen and randomly divided into 2 groups each n=30Group O received Inj ondansetron 75mcg/kg upto 8mgGroup P received Inj Palonosetron 1.5mcg/kg upto 0.075mg30 minutes before start of surgery
11MAIN INCLUSION CRITERIA Male or female patient aged more than 5 years up to 60 years.Inpatient scheduled to undergo surgical procedures requiring general endotracheal anesthesia for ear, nose and throat surgery;American Society of Anesthesiologists (ASA) physical status I, IIPatient scheduled to be hospitalized for at least 72 hours after wake up of surgery
12MAIN EXCLUSION CRITERIA History of gastro-esophageal reflux.Patient scheduled to undergo emergency surgery.Patient scheduled to receive propofol during the maintenance phase of anesthesia.Patient with vomiting from any organic cause.Any drug with a potential anti-emetic effect within 24 hours prior to the administration of anesthesia.Any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia.
13Materials IV cannulae Monitors Drugs for general anaesthesia Drug O Ondansetron 4mgDrug P Palonosetron mg
14METHODS Premedication: Inj. Glycopyrolate 0.004 mg/kg iv, Inj. Midazolam 0.02mg /kg iv,Inj. Fentanyl 2 mcg/kg iv.Anaesthesia was induced withInj. Thiopentone 5mg/kg iv andInj succinylcholine 2mg /kg ivIntubated with appropriate sized ETTplacement confirmed .
15METHODS Anaesthesia was maintained with N2O: O2 70:30%, Isoflurane 1% with controlled ventilationMuscle relaxant Inj Atracurium loading dose of 0.5mg/kg followed by a maintanence dose of 0.1mg/kg was usedAfter adequate spontaneous respiratory effect reversed with Inj neostigmine 50mcg/kg with Inj glycopyrrolate 40mcg/kg.During maintenance of anesthesiaHeart rate, Mean arterial blood pressure, ECGSpo2, respiratory rate, end-tidal CO2 concentration,
16Post operative: Data collected over 72 hrs post op. No of emetic episodes recorded and time at which it occurred.Emetic episode is defined as single vomit or retch or a combinationComplete response: No emetic episodeMajor response :one emetic episodeTreatment failure: 2 or more episode or the receipt of an rescue anti emeticData recorded & results were statistically evaluated
17RESULTS ONDANSETRON MEAN AGE 26+/-4 [5yrs-50yr] SEX M/F 15/15 DEMOGRAPHIC DISTRIBUTION:PALONOSETRONMEAN AGE:24+/-5 [5Yrs-52]SEX:M/F 14/16ONDANSETRONMEAN AGE 26+/-4 [5yrs-50yr]SEX M/F 15/15
21CONCLUSIONS Emesis and nausea female>male Emesis early 0-12 hrs comparableEmesis delayed hrs palonosetron superiorPalonosetron superior in controlling nauseaHeadache symptoms comparable
22PROFORMA NAUSEA Mild moderate severe NAME : AGE/SEX: IP NO: WEIGHT: ASA I IIDIAGNOSIS: SURGERY PLANNED:PREMED: TIME OF DRUG ADMINISTERED:TECHNIQUE OF ANESTHESIA:CONDITION AT THE END OF SURGERY:PONV FIRST 2 HRS HRSNO OFEMETICEPISODESNAUSEA Mild moderate severe
23REFERENCESApfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology.1999;91(3):693–700.Management of PONV focus on palonosetron Neil muchatuta michael peach 2008K. A. Candiotti, A. L. Kovac, T. I. Melson, G. Clerici, T. Joo Gan, and The Palonosetron Study Group A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Three Different Doses of Palonosetron Versus Placebo for Preventing Postoperative Nausea and Vomiting Anesth. Analg., August 1, 2008; 107(2):Palonosetron Hcl in the prevention of PONV Jane wallenborn and Peter crank dept of anesthesiology University of leizpig.GermanyGralla R, Lichinitser M, Van der Vegt S, Sleeboom H, Mezger J, Peschel C, Tonini G, Labianca R, Macciocchi A, Aapro M. Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase III trial comparing single doses of palonosetron with ondansetron. Ann Oncol 2003;14:1570–7Stoltz R, Cyong J-C, Shah A, Parisi S. Pharmacokinetic and safety evaluation of palonosetron, a 5-hydroxytryptamine-3 receptor antagonist, in U.S. and Japanese healthy subjects. J Clin Pharmacol 2004;44:520–31