Comparison of palonosetron with ondansetron for preventing post operative nausea and vomiting in patients undergoing abdominal surgeries - A comparative study

Abstract               The Post operative nausea and vomiting (PONV) is a very common unpleasant feature and big problem rather a challenge after General as well as regional especially spinal and epidural anaesthesia in almost all abdominal surgeries including laparoscopic surgeries. In this prospective study 60 ASA I and II patients in the age of 18 to 75 years of age undergoing all types of abdominal surgeries under spinal and general anaesthesia will be randomly allocated to two groups.

Key Words: Palonosetron, Ondasetron, Post Operative Nausea, Abdominal surgeries Comparative study.

INTRODUCTION

The Post operative nausea and vomiting (PONV) is a very common unpleasant feature and big problem rather a challenge after General as well as regional especially spinal and epidural anaesthesiain almost all abdominal surgeries including laparoscopic surgeries. There can be high level discomfort after surgery. it can be very distressing and can sometimes result in dehydration, gastric aspiration wound dehiscence. PONV if associated with post operative pain can be more dangerous. Nausea is defined as subjectively unpleasant sensation associated with urge to vomit where as vomiting if forceful contents of gastric contents from the mouth or reteching (labored, spasmodic rhythmic contractions of respiratory muscles without expulsion of gastric contents) PONV can occur immediately after reversal of anaesthesia and incidences are more during first 24 hours and highest after abdominal surgeries. Many factors influence PONV like age, sex, opiate administration, suctioning, anaesthetic drugs, upper abdominal surgeries Etc. In high risk cases incidence can be as high as 80% indicating importance of management of vomiting and nausea during and after surgery. A number of drugs have been tried for prevention of PONV like Antihistaminics, Butyrophenone and Dopamine antagonist receptor antagonist but there are many side effects like excessive Sedation, Hypertension, Dyphoria, Hallucination, extra pyramidal symptoms but so far as no claim can be made for any drug for excellent results. 5 HT 3 receptor antagonist has been in used for last 25 years and produced less side effects presently in this category. Inj metoclopramide 4 mg has been in use for many decades used but was in-effective Inj. Onda¹ Setronis also being widely used for PONV and other 5HT3 receptor newer drugs likeInj. PalonoSetron and Granisetron, Dolasetron, Tropisetron, Roma Setronanti emetic agents have been tried with minimum side effects and is being compared. VAS Visual analog scale was widely used for observing nausea and vomiting V =0 means no vomiting and 10 means worst vomiting or nausea now a days. With the invention of new drugs having more efficacy over ondasetron and meta clopramide and effective for longer duration of time we decided to conduct present study and This is first study of Palonosetronat this institute and in this study prospective, randomized and double blinded study we will compare efficacy of Palonosetron with Onda Setron. Palonosetron is selective serotonin subtype 3 (5 HT3) receptor dose 0.075 mg Antagonist and effect remains for 24 hours with single dose where as Ondasetron 8 mg intravenously remains effective for only one to 2 hours.

Inclusion criteria and informed consent

Informed consent will be taken and procedure will be explained in details to each and every patient before induction of Spinal and general anaesthesia undergoing for elective abdominal surgeries. All cases of ASA Grade I and II will be selected for study assessment of intraoperative and postoperative recovery period.

Exclusion Criteria: Non consenting patient, patients with any previous history of hypersensitivity or any known side effect of drugs, pregnancy, lactation administration of any anti psychotic drugs, steroids within 24 hours before surgery, presence of any respiratory or CVS Disease, obesity (body mass more than 35) will be excluded from the study.

Premedication each patient will be given premedication with analgesic like Inj. butorphanol 1 mg, Inj. midzolam 1 mg, ( 0.05 mg per kg ) Inj. glycopyrrolate 0.2 mg (0.004Mg per Kg) half hour before surgery
MATERIAL AND METHODS

After getting the clearance from Institutional Ethics Committee (IEC), with help of computer generated random number table, the selection of patients will be done randomly and drugs will be given by anaesthsilogist not involved in study.

In this prospective study 60 ASA I and II patients in the age of 18 to 75 years of age undergoing all types of abdominal surgeries under spinal and general anaesthesia will be randomly allocated to two groups:

Group A: Palono Setronand Group B ondasetron of 30 each.

Group A: to receive Injection Palono Setron Ampoule having 1.5 ml with 0.075 mg before induction of anaesthesisa

Group B: Will be given injection Inj. OndaSetron8 mg intravenously before induction of anaesthesia

In both groups after keeping patients fasting since midnight and Tablet Ranitidine 150 mg, Tab Alparax 0.25 mg in the night and after premedication in OT and induction agents like Propofol 2 mg per kg, and inhalational agents like Oxygen 100% 3 litres / N₂O 3litres and isoflurane 0.5 % will be given to all pateints and muscle relaxant like Succinyl choline 2 mg per kg for cases under GA and Inj Bupivacaine 0.5% heavy for cases under spinal anaesthesia will be given. Haemodynamic status like heart rate, blood pressure, oxygen saturation, ETCO _2, any side-effects as well as complications will be compared between these two groups. During surgery Oxygen and nitrous oxide will be given in 1;2 ratio with Isoflurane in the concentration 0.5% to 1% and complications, side effects during operative and post operative recovery period if any and will be concluded. Haemodynamic parameters will be compared before induction to post operative period till patient is shifted toward duration of action will be in 24 hours in Post operative period will be calculated from first dose up of anti emetic agents first two hours then 2-6 hours, 6-12 hours and 12 to 24 hours for frequency of episode for nausea and vomiting.. Appropriate distribution of demographic data like age, sex, body weight, Duration and category of surgery, previous history of PONV, use of opioids in post operative period and haemodynamic changes and adverse effects like Base line Heart rate, Mean Arerial Pressure, Headache, Dizziness, Bradycardia, Hypertension, Pruritis if any will be recorded. Requirement of rescue Medication in both groups will be recorded. Patients satisfaction will be recorded satisfied, neutral unsatisfied at the end of study

Statistical Analysis

The data collected from this prospective, randomized, double blind study will be entered into a master chart and necessary statistical tables will be constructed. The statistical constants like arithmetic mean, standard deviation, percentage etc will be computed to get valid inference about the data for comparison. In order to see whether the difference in estimates in the study groups are statistically significant, the students unpaired ‘t’ test and Fischer’s exact proportions will be applied. Individual unpaired t test will be applied for comparison of intraoperative post operative hemodynamic parameters and the results will be analyzed using ANOVA test for comparison between groups and within groups. A P value of less than 0.05 will be considered statistically significant.

REFERENCES

• Randomised comparative study for efficacy of Palonosetron v/s Ondasetronconducted by k sureshkumar and others in international journal of scientific study march 2018 vol 3 issue 12 page 288 to 294.
• Palonosetron versus Ondasetron for prevention of post operative nausea and vomiting in patients under goinglaproscopic cholecystectomy by DrNeelam Singh and others published in international journal of dental and medical sciences vol 15, issue 2 ver xi feb 2016 PP 45-48
• Comparison of Palonosetron with Ondasetron in prevention of post operative nausea and vomiting in patients receiving patient controlled intravenous analgesia after gynecological laprocopic surgeries. korean journal of anaesthesiology 2013 feb 64 (2)PP 122 -126.
• Palonosetron versus ondasetron as rescue medicine in post operative nausea and vomiting a comparative study by keith A Candioti and others BMC Pharmacology and toxicology, 2014 page 1 to 8.
• Comparison of granisetron and palonosetron and ondasetron for prevention of post operativenasea and vomiting in gynaecological surgeries under general anaesthesia by Sandiptakumar Annuls of international journal of dental and medical research vol. 3 issue 3 page March 2017 40 to 44.