Subhash

Haloperidol Plus Ondansteron Versus Ondansteron alone for
prophylaxis of Post operative nausea and vomiting
Subhash Rai , Gyanander Singh Attresh , Prabhu B.G , Rajesh Kumar B.P.
Dept of Oral & Maxillofacial Surgery, Bapuji Dental College & Hospital, Davangere Background and Objectives: Nausea and vomiting are the most common distressing symptom in the post operative period after General Anaesthesia so the present study was designed to compare the efficacy of haloperidol plus ondansetron and ondansetron alone in the prevention Methods:. In first Group (Group I) 30 patients were randomly allocated to receive IV ondansetron 4mg and IV saline 0.2 ml 1 hour before the anticipated end of the surgery. In second Group (Group II) patients randomly received IV ondansetron 4mg and IV haloperidol 0.2 ml (1mg) 1 hour before the anticipated end of the surgery. Episodes of nausea, Vomiting/Retching, Rescue treatment and side effects were noted at the end of 1st,3rd and 8th hour. Results: The post operative nausea had a mean of 0.77 in Group I and 0.20 in Group II at 1st hour and a mean of 1.23 in Group I and 0.20 in Group II at 3rd hour, while at 8th hour the mean was 1.87 in Group I and 0.63 in Group II. In both the Groups all patients at 1 hour & 96.7% patients at 3 hours had Vomiting / Retching free episodes, while at 8 hours 83.3% of patients in Group I and all patients in Group II had Vomiting/Retching free episodes. More patients had received Rescue treatment in Group I as compared to Group II at 1 hour (P=0.19), 3 hours (P=0.03) and 8 hours (P=0.08). 60% patients were awake in Group I and 47% in Group II, 40% patients were arousable in Group I and 53% in Group II, while none of the patients were unarousable in both groups. Prolonged QTc interval (>450 for males and >470 for females) was found in 26.6% patients in group I and in 30% patients in Group II. Interpretation & Conclusion: The present study suggested that prophylactic haloperidol 1mg plus ondansetron 4mg IV is more efficacious than ondansetron 4mg IV in preventing postoperative nausea and vomiting in patients undergoing maxillofacial surgery under General Anaesthesia.
Key words: Haloperidol; Ondansetron; Postoperative nausea and vomiting; General
INTRODUCTION
vomiting and a combination with Droperidol may reduce Postoperative nausea and vomiting (PONV) is one of the most common side effects following the administration This study was conducted to evaluate the efficacy of of General anesthesia during immediate recovery period. Haloperidol and Ondansetron when given as a Perrott et al found PONV to be the most common combination to prevent postoperative nausea and postoperative complication in oral and maxillofacial vomiting, against Ondansetron when given alone.
surgery. A combination of Droperidol & Ondansetron METHODOLOGY
been shown to suppress nausea less effectively than 60 patients aged 18 years or older undergoing oral and maxillofacial procedures of less than 4 hours duration Address for correspondence:
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under general anaesthesia were selected at random certificate provided No
belonging to either sex. All patients belonged to ASA I- by author
III category and weighing above 35 kgs.
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Website: http://www.ssdctumkur.org/jdsr.php Journal of Dental Sciences and Research The patients were divided randomly into 2 groups of 30 AGE WISE INCIDENCE
The Group which received IV ondansetron 4mg plus IV saline 0.2 ml.
Nausea was scored with an Eleven point verbal scale, 0= "none", 10= "worst possible".
Group II: The Group which received IV ondansetron 4mg plus IV haloperidol 0.2ml (1mg).
The nausea scoring was recorded for 1 hour, 3rd hour, and 8th hour. In 18-28 years age group the nausea was ANAESTHESIA: Before surgery monitoring of baseline significantly less in the Group II as compared to the values of heart rate, pulse, blood saturation, oxygen Group I at 1 hour (P=0.04), 3 hours (P=0.004) and 8 hours saturation and E.C.G were recorded. Approximately 1 (P=0.02) in 18-28 year age group. In 29-38 years age hour before the anticipated end of surgery, each patient group nausea was less in Group II as compared to Group I received IV 4 mg of ondansetron plus the contents of a at 1 hour (P=0.4), 3 hours (P=0.2) and 8 hours (P=0.4), coded syringe containing either 1 mg haloperidol or 0.2 which was statistically not significant at all the three time ml saline. The patients' vital parameters like pulse, intervals. In >=39 years age group nausea was less in respiration, blood pressure, oxygen saturation and E.C.G Group I as compared to Group II at 1 hour (P=1.0), 3 were monitored throughout the surgery. Nausea, hours (P=0.7) and it was less in Group II at 8 hours retching or vomiting and rescue treatment were recorded (P=1.0), which was statistically not significant at all the at 1 hour, 3 hours, and 8 hours postoperatively. The three time intervals. In total number of patients number of episodes of vomiting and retching (dry irrespective of age Group the incidence of nausea was heaves) were recorded. Repeated retching or vomiting higher in Group I than the Group II at 1 hour (P=0.04),3 occurring in a time interval of less than 5 minutes was hours(P=0.001) and 8 hours (P=0.01) and the difference was statistically significant at all the three time intervals. Nausea was scored with an Eleven point verbal scale, 0 = Vomiting/Retching
We observed vomiting and retching together. In 18-28 A rescue antiemetic (metoclopramide, 10 mg i.m.) was years age Group the incidence of vomiting was not given if the nausea was rated >2, if actual vomiting observed in both the Groups I and II at 1 hour while occurred, or at any time if requested by the patient. higher number of patients had vomiting in Group II than Nausea and vomiting assessments were made 30 minutes Group I at 3 hours (P=0.3), and it was more in Group I as after a patient had been given rescue medication.
compared to Group II at 8 hours (P=0.02), & the difference was statistically significant at 8 hours only. In A complete response was defined as absence of PONV 29-38 years age Group there was no vomiting/retching without antiemetic rescue during the 0 - 8 hour seen at 1 hour and 8 hours in both the Groups, while higher number of patients had vomiting in Group I as compared to Group II at 3 hours (P=0.7) and the Sedation was measured categorically (1-awake, difference was statistically not significant at all three 2-arousable, 3-unarousable). The QTc interval was time intervals Irrespective of age, incidence of d e t e r m i n e d f r o m p r e - a n d p o s t o p e r a t i v e Vomiting/Retching was same at 1 and 3 hours in both the electrocardiograms. QTc prolongation was defined as > Groups while it was more in Group I at 8 hours (P=0.02) 450 ms for males and > 470 ms for females. Any side & this difference was statistically significant (P=0.02).
effects experienced were also recorded. The results were tabulated at 1 hour, 3 hours and 8 hours postoperatively.
Rescue treatment
RESULTS A clinical study of 60 patients undergoing A rescue antiemetic (metoclopramide, 10mg IM) was oral and maxillofacial surgical procedures of less than 4 given if nausea was rated >2, if actual vomiting occurred hours duration under G.A. of either sex, belonging to or at any time if requested by the patient.
>=18 years age groups. All patients belonged to ASA grade-I to III and weighing above 35 kgs. This study was Group I The incidence of rescue treatment was more for undertaken to compare the safety and efficacy of 18-28 years age Group as compared to 29-38 and >=39 prophylactic use of the combination of haloperidol and years age Group at 1 hour (P=0.22), 3 hours (P=0.29), and ondansetron with ondansetron alone in preventing 8 hours (P=0.16) which was statistically not significant at all three intervals. Rescue treatment was received maximum by 18-28 year age Group and least by >=39 year age Group Group II The incidence of rescue treatment was more for incidence at 1 hour in both the Groups and the difference 18-28 year age Group as compared to 29-38 and >=39 was statistically not significant at all the three time years age Group at 1 hour (P=0.07), 3 hours (P=0.7), and 8 hours (P=0.39), which was statistically not significant at all the three time intervals. Maximum rescue treatment Rescue treatment
was received by 18-28 years age Group and minimum by 29-38 year age Group. Incidence of rescue treatment in Group I: More females received rescue treatment than all three age groups was received maximum at 8 hours males at 1 hour (P=0.6), 3 hours (P=0.4), and 8 hours and minimum for 1 hour in both Group I and Group II. (P=0.4) and the difference was statistically not Out of total number of patients in Group I and Group II, significant at all the three time intervals.
irrespective of age, more number of patients had received rescue treatment in Group I as compared to Group II at 1 Group II: More males received rescue treatment at 1 hour hour (P=0.19), 3 hours (P=0.03) and 8 hours (P=0.08), (P=0.3) while more females received rescue treatment at which was statistically significant at 3 hours only.
3 hours (P=0.3) and 8 hours (P=0.6) and the difference was statistically not significant at all the three time SEX WISE INCIDENCE
COMPLETE RESPONDERS: Complete response was considered no nausea, retching, emesis or need for rescue Group I: Nausea was more in females than males at 1 hour during the 0-8 hours postoperative period. Complete (P=0.56), 3 hours (P=0.26) and 8 hours (P=0.08) and it responders were more in Group II as compared to Group I was statistically not significant at the entire three time at 1 hour (P=0.08), 3 hours (P=0.19) and 8 hours (P=0.01) and the difference was statistically significant at 8 hours only. The number of complete responders decreased Group II: Nausea was more in males at 1 hour (P=1.0) from 1 to 8 hours in both the groups.
while it was more in females at 3 hours (P=1.0) and 8 hours (P=0.8), and the difference was statistically not SEDATION: 60% patients were awake in Group I and significant at all the three time intervals. The incidence of 47% in group II, 40% patients were arousable in Group I nausea was more in Group I males as compared to Group and 53% in Group II, while none of the patients were II males at 1 hour (P=0.6), 3 hours (P=0.2) and 8 hours unarousable in both groups and it was statistically not (P=0.4) and the difference was statistically not significant with a P value of 0.43.
significant at all the three time intervals. The incidence of nausea was more in Group I females as compared to SIDE EFFECTS: 30% patients in Group I and 20% Group II females at 1 hour, 3 hours (P=0.03) and 8 hours patients in Group II complained of headache and it was (P=0.02) and the difference was statistically significant statistically not significant with a P value of 0.86. No one had any other complaint or any extrapyramidal symptoms in both the groups. Vomiting / Retching
DISCUSSION
Group I: There was no episode of Vomiting / Retching at 1 hour in both the males and females. Incidence was more In oral and maxillofacial surgery blood loss is more due in females at 3 hours (P=0.77) and 8 hours (P=0.77), and to anatomic reasons. Swallowed blood following the difference was statistically not significant at all the intraoral procedure is a strong emetic stimulus, so thorough suctioning of the throat is mandatory. Pain, anxiety and anticholinesterases have also been Group II: There was no episode of Vomiting / Retching at implicated in PONV6,,. Many antiemetics have been 1 hour and 8 hours in both the males and females, while used in the prophylaxis and treatment of PONV. Multiple the incidence was more in females at 3 hours (P=0.77) receptors, such as dopamine type 2, 5-HT type 3, and this difference was statistically not significant. The histamine type 1, muscarinic cholinergic type 1, and incidence of Vomiting/Retching was more in Group I males as compared to Group II males at 8 hours (P=0.13) antiemetics act by blocking only one kind of receptor. while there was no incidence at 1 and 3 hours in both the Thus, using a combination of antiemetics with different Groups and the difference was statistically not mechanisms of action has gained favor for preventing significant at all the three time intervals. The incidence and treating PONV in high risk patients.
was more in Group I females as compared to Group II females at 8 hours (P=0.3), while the incidence was same In this study in Haloperidol plus Ondansetron Group all at 3 hours (P=1.0) in both the Groups and there was no patients at 1 hour, 96.7% patients at 3 hours and all Journal of Dental Sciences and Research patients at 8 hours were vomiting / retching episodes free while in Ondansetron group all patients at 1 hour, 96.7% patients at 3 hours and 83.3% patients at 8 hours experienced no vomiting / retching. The incidence of vomiting / retching was same at1 and 3 hours in both the groups while it was more at 8 hours in the Ondansetron group and this observation was statistically significant.
CONCLUSION
It is fair to conclude from this study that prophylactic treatment with a combination of IV haloperidol (1mg) and IV ondansetron (4mg) provides a higher response rate, greater patient satisfaction and a larger reduction in the incidence of PONV than ondansetron used alone, and the combination does not increase adverse outcomes. Further studies are required to assess the more accurate evaluation of haloperidol and ondansetron in the field of anaesthesia and surgery. Finally, we all look forward to that day, when postoperative nausea and vomiting will not be a problem at all.
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