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| RESEARCH ARTICLE |
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| Year : 2013 | Volume
: 45
| Issue : 1 | Page : 24-29 |
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Evaluation of antiemetic effect of intravenous palonosetron versus intravenous ondansetron in laparoscopic cholecystectomy: A randomized controlled trial
Baisakhi Laha1, Avijit Hazra2, S Mallick1
1 Department of Anesthesiology and Critical Care, Command Hospital (Eastern Command), Alipore, India
2 Department of Pharmacology, Institute of Postgraduate Medical Education and Research (IPGME&R), Kolkata, West Bengal, India
| Date of Submission | 12-Mar-2012 |
| Date of Decision | 14-Sep-2012 |
| Date of Acceptance | 29-Oct-2012 |
| Date of Web Publication | 24-Jan-2013 |
Correspondence Address:
Avijit Hazra
Department of Pharmacology, Institute of Postgraduate Medical Education and Research (IPGME&R), Kolkata, West Bengal
India
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/0253-7613.106430
Objectives: Incidence of postoperative nausea and vomiting (PONV), without active intervention, following laparoscopic cholecystectomy is unacceptably high. We evaluated the effectiveness of intravenous (IV) palonosetron in counteracting PONV during the first 24hrs following laparoscopic cholecystectomy, using ondansetron as the comparator drug.
Materials and Methods: In a randomized, controlled, single blind, parallel group trial, single pre-induction IV doses of palonosetron (75mcg) or ondansetron (4mg) were administered to adult patients of either sex undergoing elective laparoscopic cholecystectomy. There were 49 subjects per group. The pre-anesthetic regimen, anesthesia procedure and laparoscopic technique were uniform. The primary effectiveness measure was total number of PONV episodes in the 24 hrs period following end of surgery. The frequencies of individual nausea, retching and vomiting episodes, visual analog scale (VAS) score for nausea at 2, 6 and 24hrs, use of rescue antiemetic (metoclopramide), number of complete responders (no PONV or use of rescue in 24 hrs) and adverse events were secondary measures.
Results: There was no statistically significant difference between the groups in primary outcome. Similarly, the frequencies of nausea, retching and vomiting episodes, when considered individually, did not show significant difference. Nausea score was comparable at all time points. With palonosetron, 14 subjects (28.6%) required rescue medication while 13 (26.5%) did so with ondansetron. The number of complete responders was 14 (28.6%) and 16 (32.7%), respectively. Adverse events were few and mild. QT c prolongation was not encountered.
Conclusion: Palonosetron is comparable to ondansetron for PONV prophylaxis in elective laparoscopic cholecystectomy when administered as single pre-induction dose.
Keywords: Laparoscopic cholecystectomy, ondansetron, palonosetron, postoperative nausea and vomiting, randomized controlled trial
How to cite this article:
Laha B, Hazra A, Mallick S. Evaluation of antiemetic effect of intravenous palonosetron versus intravenous ondansetron in laparoscopic cholecystectomy: A randomized controlled trial. Indian J Pharmacol 2013;45:24-9 |
How to cite this URL:
Laha B, Hazra A, Mallick S. Evaluation of antiemetic effect of intravenous palonosetron versus intravenous ondansetron in laparoscopic cholecystectomy: A randomized controlled trial. Indian J Pharmacol [serial online] 2013 [cited 2023 Jun 1];45:24-9. Available from: https://www.ijp-online.com/text.asp?2013/45/1/24/106430 |
| » Introduction | |  |
Postoperative nausea and vomiting (PONV) is a common and distressing complication of surgery under general anesthesia. Its overall incidence can rise to 80% in high-risk patients. [1] The incidence of PONV remains unacceptably high (40-75% in the first 24hrs, without active intervention) following laparoscopic cholecystectomy. [2],[3]
PONV is influenced by multiple patient, surgery and anesthesia related factors and requires release of 5-hydroxytryptamine (5- HT) in a cascade of neuronal events involving both the central nervous system and the gastrointestinal tract. The 5-HT subtype 3 (5-HT 3 ) receptors participates selectively in the emetic response.
Advances in PONV prophylaxis over recent years include use of non-pharmacological measures to reduce baseline risk, a change to less emetogenic anesthetic techniques and the use of new antiemetic drugs. However, the use of antiemetics, either alone or in combination, remains the mainstay in PONV management. Drugs used include metoclopramide, haloperidol, dexamethasone and the selective 5-HT 3 receptor antagonists. The last group is now a first line option because of effectiveness and general lack of adverse drug reactions. [4],[5] Most clinical research with the 5-HT 3 receptor antagonists has used ondansetron, and its antiemetic efficacy is well established in chemotherapy- induced emesis and in the treatment and prevention of PONV. However, several alternatives to ondansetron (e.g. granisetron, tropisetron, dolasetron, ramosetron) are now available. Palonosetron, approved by the Drugs Controller General of India on 25.04.2009, is the most recently introduced member of this class of drugs in India. Its interaction pattern with the 5-HT 3 receptor is different from earlier 5-HT 3 receptor antagonists, enabling a higher binding affinity and longer half-life. [5],[6] The mean terminal elimination half-life, following single intravenous (IV) dose, is approximately 40 hours. Therefore the duration of action exceeds 24hrs, and may extend to 48 hours.
Palonosetron has been compared with placebo for the prevention of PONV in patients undergoing open abdominal and gynecological surgery. [7],[8] Comparison with other antiemetic drugs and in other types of surgery is still limited. We therefore evaluated the antiemetic effectiveness of IV palonosetron, administered as a single pre-induction dose, in laparoscopic cholecystectomy during the first 24 postoperative hours, using the prototype 5-HT 3 receptor antagonist ondansetron as comparator drug.
| » Materials and Methods | | |
In a prospective, randomized, controlled, single blind, parallel group trial, single pre-induction IV dose of palonosetron (75 mcg fixed dose) or ondansetron (4 mg fixed dose) were administered to adult patients (over 18 years age) of either sex undergoing elective laparoscopic cholecystectomy at a tertiary care hospital. The study was cleared by the institutional Ethics Committee and written informed consent was obtained from all subjects prior to recruitment.
Exclusion criteria were pregnancy, body weight exceeding 30% of ideal body weight, distinct spells of nausea, vomiting or retching within 24 hrs prior to surgery; use of corticosteroids, psychoactive drugs or any other medication with known emetic or antiemetic effect within 24 hrs prior to surgery; significant disease of major organs like liver, kidneys, heart, lungs and bone marrow; known hypersensitivity to study medication; history of alcohol or substance abuse; and participation in any other clinical trial within past 1 month. Simple randomization was done in 1:1 ratio on the basis of a computer generated random number list and allocation was concealed till the point of drug administration using serially numbered opaque sealed envelopes. The medication was administered in a single blind manner, taking care to ensure that the patient was not aware of the exact identity of the antiemetic drug that he or she received, either before or during the 24 hrs observation period following surgery.
The pre-anesthetic regimen, anesthesia procedure and laparoscopic technique were uniform for all subjects. On arrival in the operation theatre, routine monitoring devices were placed in situ, including non-invasive arterial pressure, capnography, ECG and pulse oximetry. A suitable peripheral vein was cannulated for administration of anesthetic agents and IV fluids. The study medications were prepared and 1 minute before induction of anesthesia, patients received either palonosetron 75 mcg IV or ondansetron 4 mg IV, as per the randomization code. Anesthesia was induced with thiopental 5-7 mg/kg IV. Tracheal intubation was facilitated by succinylcholine 2 mg/ kg IV or an intermediate acting muscle relaxant - vecuronium 0.08 mg/kg IV or atracurium 0.5 mg/kg IV. Anesthesia was maintained with nitrous oxide and sevoflurane (1-2%) in oxygen. Muscle relaxation was maintained by intermittent bolus doses of vecuronium or atracurium. Analgesia was maintained by fentanyl 2 mcg/kg, IV. Ventilation was controlled and adjusted to maintain the end tidal partial pressure of CO 2 between 4.7 and 5.3 kPa (35 - 40 mmHg).
Laparoscopic cholecystectomy was performed under video guidance and involved four punctures of the abdomen. During surgery, patients were placed in the reverse Trendelenburg position with the right side of the bed elevated and abdomen insufflated with CO 2 through a Veress needle to a maximum of 17 mmHg. At cessation of surgery, residual neuromuscular block was reversed using IV glycopyrrolate and neostigmine and the subject subsequently extubated. All patients received diclofenac sodium 75 mg IM approximately 20 minutes before the end of surgery.
For the purpose of the study, an episode of PONV denoted either a distinct spell of nausea, retching (an involuntary attempt to vomit but not actually productive of stomach contents) or vomiting (actual expulsion of stomach contents). The primary effectiveness measure was the total number of PONV episodes in the 24hrs period following conclusion of laparoscopic surgery. The secondary efficacy variables were:
- Frequency of nausea, retching and vomiting episodes, individually, in the 24hrs period following the surgical procedure.
- Nausea severity score (as assessed using a 10 cm Visual Analogue Scale) at 2, 6, and 24hrs after completion of surgery.
- Use of rescue antiemetic medication (metoclopramide 10 mg orally).
- Number of complete responders - no emetic episodes and no rescue medication.
- Overall satisfaction with the nausea-vomiting experience on a four-point Likert scale (dissatisfied, neutral, satisfied, and highly satisfied) at 24hrs after surgery completion.
Metoclopramide 10 mg orally was permitted as rescue medication, to be administered if nausea severity attained 5 cm or more on the VAS scale, or on demand. Safety of the study drugs was assessed by monitoring vital signs, oxygen saturation and ECG and examining and asking the patients for treatment emergent adverse events for 24hrs following surgery.
Sample size was calculated on the basis of the primary outcome measure. It was estimated that 49 subjects would be required per group in order to detect 2/3rd reduction in the frequency of PONV from the control treatment (from 40 to 15%) with 80% power and 5% probability of type one error. Data were captured on structured case report forms. Numerical variables were compared between groups by Student's t test, if normally distributed, or by Mann-Whitney U test, if otherwise. Fisher's exact test was employed for intergroup comparison of categorical variables. Missing data were not imputed. All analyses were two-tailed. Statistically significant implied p < 0.05. The raw data was entered into a Microsoft Excel spreadsheet and analyzed by Statistica version 6 (Tulsa, Oklahoma: StatSoft Inc., 2001) and GraphPad Prism version 4 (San Diego, California: GraphPad Software Inc., 2005) statistical software.
| » Results | | |
The study was completed by all recruited subjects. As seen from [Table 1], age, weight and gender distribution were comparable between groups. Similarly, surgery and anesthesia related parameters were also comparable, as shown in the same table. | Table 1: Profile of baseline characteristics and surgery related parameters
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The primary efficacy variable for this study, namely the frequency of all PONV episodes in the 24hrs period following the surgical procedure, did not show any statistically significant difference between groups [Table 2]. Likewise, the frequency of nausea spells, retching events and vomiting episodes, when considered individually, did not show any difference [Table 3]. | Table 2: Comparison of frequency of sum total of all PONV episodes between study groups
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 | Table 3: Comparison of frequency of nausea, retching and vomiting episodes in patients administered palonosetron and ondansetron
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VAS scoring of nausea severity was comparable between groups at 2, 6 and also 24hrs following surgery [Figure 1]. In the palonosetron arm, 14 (28.6%) subjects required at least one dose of rescue medication while the corresponding number was 13 (26.5%) in the other arm. The number of complete responders (no PONV episodes and no rescue) was 14 (28.6%) on palonosetron and 16 (32.7%) on ondansetron. Both these differences were statistically non-significant. Subjects also rated the drugs similarly, with around 88% satisfied with their PONV experience in both arms. | Figure 1: Mean Visual Analog Scale (VAS) score for nausea at successive time points in the two study groups. There was no statistically signifi cant difference between groups. Note that no nausea was reported in the ondansetron arm at 24 hrs
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Regarding safety assessment, the heart rate and mean arterial blood pressure were raised in the immediate post-intubation period, but the changes were comparable for the two drugs. Mean oxygen saturation did not show any significant change in either arm. [Table 4] lists the few treatment emergent adverse effects that were encountered in the 24hrs period following completion of the laparoscopic cholecystectomy procedure. Altogether two subjects (2.04%) in the palonosetron arm and 7 (14.29%) in the ondansetron arm are complained of one or more adverse events. Except for pain on swallowing which lasted in the affected subject for about two days, all other events subsided within 24hrs. All events were of mild to moderate severity and settled spontaneously without separate treatment. It was not possible to link these adverse events conclusively to the prophylactic antiemetic medication received (i.e. to palonosetron or ondansetron) as all patients were also receiving prophylactic antibiotics and analgesic medication (diclofenac), in addition to the drugs they had received as pre-anesthetic medication and during anesthesia. There was no instance of corrected QT interval prolongation (QT C > 450 milliseconds) in either of the study groups.
| » Discussion | | |
The postoperative period is associated with variable incidence of nausea and vomiting depending on the duration of surgery, the type of anesthetic agents used (dose, inhalational drugs, opioids), smoking habit etc. [9] 5-HT 3 receptor stimulation is the primary event in the initiation of vomiting reflex. [10] Anesthetic agents trigger this reflex by stimulating central 5-HT 3 receptors in the medullary chemoreceptive trigger zone (CTZ) and also by releasing serotonin from the enterochromaffin cells of the small intestine and subsequent stimulation of 5-HT 3 receptors on vagus nerve afferent fibres. [11]
The incidence of PONV after laparoscopic surgery is high. The etiology is complex, being dependent on a variety of factors including age, obesity, a history of previous PONV, surgical procedure, anesthetic technique, and postoperative pain. [12],[13],[14],[15],[16] In this study, the groups were comparable with respect to patient demographics, type and duration of surgery, anesthesia regimen and antibiotics and analgesics used postoperatively. Therefore any difference in response between the groups is attributable to study drugs.
Ondansetron is effective for the treatment of emesis induced by cancer chemotherapy and surgery. The precise mechanism of this remains unclear. It has been suggested that 5-HT 3 receptors are found in the gut and in areas of the central nervous system associated with the regulation of nausea and vomiting, being abundant in the CTZ which has projections to the vomiting center located in the lateral reticular formation of the medulla oblongata. [17],[18] Stimulation of these receptors triggers the vomiting reflex. [11] Peripheral 5-HT 3 receptors are located in vagal nerve terminals, which are linked to the vomiting center via the nucleus tractus solitarius. Competitive inhibition by 5-HT 3 receptor antagonists at these sites can block triggering of the vomiting reflex by emetogenic stimuli.
Palonosetron is a novel 5-HT 3 receptor antagonist first approved for the prevention of chemotherapy induced nausea and vomiting. It has greater binding affinity and longer biological half-life than older 5-HT 3 receptor antagonists. [7] The mechanism of its action in PONV prophylaxis is also to be confirmed but the primary mechanism is possibly similar to ondansetron. Any differences between the drugs could stem from differences in pharmacokinetics or receptor binding profiles.
The dose of ondansetron selected for this study (single pre-induction dose of 4 mg IV) is within its known effective dose range. [19] However, the dose of palonosetron used (single pre-induction dose of 75 mcg IV) is not firmly established and is extrapolated from the doses used in earlier clinical trials. [20],[21] Kovac and colleagues demonstrated that palonosetron 75 mcg is the more effective dose for the prevention of PONV after major gynecological and laparoscopic surgery than 25 mcg and 50 mcg. [21] We did not include a control group receiving placebo. Aspinall and Goodman have suggested that if active drugs are available, placebo controlled trials may be unethical because PONV episodes are highly distressing after laparoscopic surgery. [22]
This study suggests that the antiemetic efficacy of palonosetron is similar to that of ondansetron for preventing PONV during the first 24hrs after laparoscopic cholecystectomy and that palonosetron is as effective as ondansetron for getting a complete response (no PONV, no rescue medication) in this period. Thus, despite the difference in half lives (ondansetron 3.5 - 5.5hrs versus palonosetron 40hrs) and binding affinities to 5-HT 3 receptor (palonosetron interacts with 5-HT 3 receptors in an allosteric, positive cooperative manner at sites different from those that bind ondansetron), [7],[8] palonosetron did not have an antiemetic effect superior to ondansetron. These results are at variance with some recently published studies of palonosetron in PONV prophylaxis. Moon et al[23] found palonosetron to be more effective than ondansetron for high-risk patients receiving fentanyl-based patient controlled analgesia after thyroidectomy in the 2-24hrs period following surgery, although there was no difference in the initial 2 hours. A single dose of palonosetron (250 mcg) was found to be a superior antiemetic to ondansetron (8 mg) in complete prevention of PONV after middle ear surgery during the first 24hrs postoperative period. [24] In a randomized controlled trial in day care surgery, single pre-induction IV dose of palonosetron (75 mcg) proved to be superior to ondansetron (8 mg) in terms of the number of subjects experiencing PONV episodes and the dose of rescue antiemetic required. [25] In a trial in gynecological laparoscopic surgery, incidence of PONV was significantly lower with palonosetron than with ondansetron, although there were no significant differences in VAS scores for nausea. [26] It is possible that antiemetic effectiveness may vary with the type of surgery and that in laparoscopic cholecystectomy, the two drugs are comparable. Bhattacharjee et al[27] have reported that prophylactic therapy with palonosetron is more effective than granisetron for prevention of PONV after laparoscopic cholecystectomy in the 24-48 hour postoperative period, though not in the first 24hrs. Therefore there is ground for further comparative studies between palonosetron and other 5-HT 3 receptor antagonists in laparoscopic cholecystectomy.
Adverse effects with single IV dose of the study drugs were not serious and there were no significant differences in the incidence of headache, dizziness or drowsiness between the groups. Concerns have been raised over the QTc interval prolonging effect of ondansetron and the risk of subsequent ventricular tachycardia. [28],[29] However, there was no QTc interval prolongation or other ECG abnormalities in this study. Thus both palonosetron and ondansetron are devoid of clinically important adverse effects when used in this manner. The study was completed by all recruited subjects. The lack of troublesome adverse effects no doubt contributed in this regard.
This study has its share of limitations. Most importantly, a double blind comparison would have carried greater weight but logistical difficulties compelled us to settle for single blinding. Some degree of subjectivity is inevitable in the assessment of patient satisfaction profile. Ideally, all subjects should have undergone the trial without use of any concomitant medication that may influence the risk of PONV. However, although we excluded patients receiving drugs that obviously can influence emesis, such as psychotropic medication, we did not exclude all concomitant medication like antihypertensives and antidiabetics. Finally, the postoperative antibiotic and analgesic regimens should have been identical in all cases. In practice, this was similar in most cases but not necessarily exactly identical.
In conclusion, this randomized, controlled, single blind comparison has shown that single pre-induction IV dose of palonosetron is as effective as ondansetron for counteracting PONV after laparoscopic surgery. However, rescue antiemetic is likely to be required in around 70% cases. This holds for the first 24 hour period following surgery. It remains to be explored if the same is true for the next 24hrs. The use of palonosetron as prophylactic antiemetic also merits exploration in other types of major surgery.
| » Acknowledgements | | |
We acknowledge with gratitude the cooperation and assistance we received from Col. S. R. Ghosh, Senior Advisor, Department of Surgery, and Dr. Aradhana Sinha, Resident, Department of Anesthesiology and Critical Care of Command Hospital (Eastern Command), Kolkata, without which the study could not have been completed.
| » References | | |
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[Figure 1]
[Table 1], [Table 2], [Table 3], [Table 4]
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Update on the management of postoperative nausea and vomiting |
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