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The goal of this clinical trial is to compare the effectiveness of two antiemetic drugs, palonosetron and ondansetron, when given alongside dexamethasone as a preventive measure against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent patients with idiopathic scoliosis undergoing posterior spinal fusion surgery under total intravenous anesthesia (TIVA).
The main questions the study aims to answer are:
Participants in the study will be randomly assigned to receive either palonosetron or ondansetron in addition to dexamethasone as part of their anesthesia and antiemetic regimen. The incidence and/ or severity of nausea, vomiting and retching will be assessed at 1 hour, 4 hours, 12 hours, 24 hours and 48 hours after surgery.
BACKGROUND/ JUSTIFICATION Postoperative nausea and vomiting (PONV) is a common complication following surgery and can cause significant morbidity. It occurs in 20-30% of the general population and up to 75-80% in high-risk groups. Children have a higher incidence of PONV compared to adults. PONV can occur at various timeframes after surgery and has clinical and financial consequences, including wound complications, dehydration, and prolonged hospitalization. Prevention and treatment of PONV are crucial for comprehensive perioperative care.
Posterior spinal fusion surgery for idiopathic scoliosis is a complex and painful procedure, increasing the risk of PONV. Various strategies can be employed to mitigate these risks, such as adequate hydration, the use of intravenous antiemetics, avoiding volatile anesthetics, and adopting a multimodal analgesic approach. Dexamethasone and anti-serotonergic drugs like ondansetron are commonly used antiemetics due to their efficacy and safety profiles. Dexamethasone is particularly favored for its long duration of action and pain-reducing effects.
Palonosetron, a second-generation anti-serotonergic drug, has a unique pharmacokinetic profile with a prolonged duration of action. It may be more beneficial for patients on prolonged opioid-based analgesic regimens. However, its higher cost and inconsistent study findings limit its widespread use, especially in scoliosis patients undergoing spinal fusion surgery.
Total intravenous anesthesia (TIVA) is recommended for high-risk PONV patients, as it reduces the emetogenic effect of volatile anesthetics. Propofol, used in TIVA, is itself an effective antiemetic. TIVA with propofol has been shown to be as effective as giving a single antiemetic and can further reduce the risk of PONV when combined with other prophylactic antiemetics.
The standard practice for managing PONV involves the administration of two antiemetics and considering TIVA for high-risk patients. This study aims to compare the effectiveness of palonosetron and ondansetron when administered alongside dexamethasone in scoliosis patients undergoing spinal fusion under TIVA. The study will also evaluate the number of rescue antiemetics needed, assess adverse effects, and measure patient satisfaction.
The study will be randomized and double-blinded, to be conducted in Universiti Malaya Medical Centre (UMMC). The sample size is calculated to be 92 participants, after taking into account a 20% dropout rate. Adult and adolescent idiopathic scoliosis patients undergoing posterior spinal fusion surgery will be eligible for the study. Written informed consent will be obtained from participants or their guardians, and assent will be obtained from adolescent participants. Patients will be randomized to receive either palonosetron or ondansetron along with dexamethasone.
The study will follow standard anesthetic techniques, including TIVA with remifentanil and propofol. Intravenous injections of the study drugs or placebo will be given during surgery, and dexamethasone will be administered as a baseline antiemetic. Morphine will be administered before the end of surgery for pain management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Group A will receive a stat dose of IV palonosetron 1.5mcg/kg prior to commencement of general anaesthesia. |
|
| Group B | Active Comparator | Group B will receive a stat dose of IV ondansetron 0.15mg/kg at the start of wound closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palonosetron | Drug | IV palonosetron 1.5mcg/kg prior to commencement of general anaesthesia |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of PONV | To compare the effectiveness of palonosetron and ondansetron when administered alongside dexamethasone as prophylaxis against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent idiopathic scoliosis patients undergoing posterior spinal fusion surgery under total intravenous anaesthesia. | At 1 hour after surgery |
| Incidence of PONV | To compare the effectiveness of palonosetron and ondansetron when administered alongside dexamethasone as prophylaxis against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent idiopathic scoliosis patients undergoing posterior spinal fusion surgery under total intravenous anaesthesia. | At 4 hours after surgery |
| Incidence of PONV | To compare the effectiveness of palonosetron and ondansetron when administered alongside dexamethasone as prophylaxis against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent idiopathic scoliosis patients undergoing posterior spinal fusion surgery under total intravenous anaesthesia. | At 12 hours after surgery |
| Incidence of PONV | To compare the effectiveness of palonosetron and ondansetron when administered alongside dexamethasone as prophylaxis against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent idiopathic scoliosis patients undergoing posterior spinal fusion surgery under total intravenous anaesthesia. | At 24 hours after surgery |
| Incidence of PONV | To compare the effectiveness of palonosetron and ondansetron when administered alongside dexamethasone as prophylaxis against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent idiopathic scoliosis patients undergoing posterior spinal fusion surgery under total intravenous anaesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Developing Postoperative Nausea Vomiting Requiring Rescue Antiemetic Within 48 hours After Surgery | Any occurrence of severe nausea and retching with visual analogue scale score ≥4; and vomiting of 1 or more episodes will be treated with the rescue drug IV metoclopramide. For adolescent subjects (aged less than 18 years old), IV metoclopramide will be given at 0.2mg/kg, with a maximum dose of 10 mg intravenously up to 3 times per day. For adult patients (18 years old and above), IV metoclopramide 10mg will be given, up to 3 times per day. If there is any further occurrence of PONV within 8 hours of administration of IV metoclopramide, a second line of rescue antiemetic, IV ondansetron 4mg, will be administered to participants in both arms of the study. The administration of any rescue medications will be recorded and taken into account during data processing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siti Nadzrah Binti Yunus, MAnaes, MBBS | University of Malaya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Malaya | Pantai Valley | Kuala Lumpur | 59100 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30443060 | Background | Kumar A, Solanki SL, Gangakhedkar GR, Shylasree TS, Sharma KS. Comparison of palonosetron and dexamethasone with ondansetron and dexamethasone for postoperative nausea and vomiting in postchemotherapy ovarian cancer surgeries requiring opioid-based patient-controlled analgesia: A randomised, double-blind, active controlled study. Indian J Anaesth. 2018 Oct;62(10):773-779. doi: 10.4103/ija.IJA_437_18. | |
| 9370838 |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D000077924 | Palonosetron |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D007546 | Isoquinolines |
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After taking informed consent and recruitment of eligible participants, they will be randomized using a sequentially numbered, opaque sealed envelope (SNOSE) method. 74 radio-opaque envelopes will be prepared according to two groups: 37 participants for each Group A, Palonosetron and Group B, Ondansetron. Group A will receive IV palonosetron 1.5mcg/kg prior to commencement of general anaesthesia; while Group B will receive IV ondansetron 0.15mg/kg at the start of wound closure.
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| Ondansetron |
| Drug |
IV ondansetron 0.15mg/kg at the start of wound closure |
|
| At 48 hours after surgery |
| At 1 hour, 4 hours, 12 hours, 24 hours and 48 hours after surgery |
| Number of Participants Developing Adverse Effects Related to the Study Drugs. | Such as headache, dizziness and constipation | Overall, assessed at 48 hours after surgery |
| Degree of patient satisfaction as represented on the Visual Analogue Scale | On a scale of 1 (least satisfied) to 5 (most satisfied) | Overall, assessed at 48 hours after surgery |
| Background |
| Kotiniemi LH, Ryhanen PT, Valanne J, Jokela R, Mustonen A, Poukkula E. Postoperative symptoms at home following day-case surgery in children: a multicentre survey of 551 children. Anaesthesia. 1997 Oct;52(10):963-9. doi: 10.1111/j.1365-2044.1997.203-az0338.x. |
| 12472709 | Background | Villeret I, Laffon M, Duchalais A, Blond MH, Lecuyer AI, Mercier C. Incidence of postoperative nausea and vomiting in paediatric ambulatory surgery. Paediatr Anaesth. 2002 Oct;12(8):712-7. doi: 10.1046/j.1460-9592.2002.00952.x. |
| 3195743 | Background | Patel RI, Hannallah RS. Anesthetic complications following pediatric ambulatory surgery: a 3-yr study. Anesthesiology. 1988 Dec;69(6):1009-12. doi: 10.1097/00000542-198812000-00044. No abstract available. |
| 7158749 | Background | Rowley MP, Brown TC. Postoperative vomiting in children. Anaesth Intensive Care. 1982 Nov;10(4):309-13. doi: 10.1177/0310057X8201000402. |
| 15141796 | Background | Awad IT, Moore M, Rushe C, Elburki A, O'Brien K, Warde D. Unplanned hospital admission in children undergoing day-case surgery. Eur J Anaesthesiol. 2004 May;21(5):379-83. doi: 10.1017/s0265021504005058. |
| 24057415 | Background | Kovac AL. Update on the management of postoperative nausea and vomiting. Drugs. 2013 Sep;73(14):1525-47. doi: 10.1007/s40265-013-0110-7. |
| 12402719 | Background | Dolin SJ, Cashman JN, Bland JM. Effectiveness of acute postoperative pain management: I. Evidence from published data. Br J Anaesth. 2002 Sep;89(3):409-23. |
| 15947124 | Background | Golembiewski J, Chernin E, Chopra T. Prevention and treatment of postoperative nausea and vomiting. Am J Health Syst Pharm. 2005 Jun 15;62(12):1247-60; quiz 1261-2. doi: 10.1093/ajhp/62.12.1247. |
| 10730546 | Background | Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs. 2000 Feb;59(2):213-43. doi: 10.2165/00003495-200059020-00005. |
| 10485781 | Background | Apfel 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 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022. |
| 11883387 | Background | Apfel CC, Kranke P, Eberhart LH, Roos A, Roewer N. Comparison of predictive models for postoperative nausea and vomiting. Br J Anaesth. 2002 Feb;88(2):234-40. doi: 10.1093/bja/88.2.234. |
| 32467512 | Background | Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833. |
| 15562045 | Background | Eberhart LHJ, Geldner G, Kranke P, Morin AM, Schauffelen A, Treiber H, Wulf H. The development and validation of a risk score to predict the probability of postoperative vomiting in pediatric patients. Anesth Analg. 2004 Dec;99(6):1630-1637. doi: 10.1213/01.ANE.0000135639.57715.6C. |
| 21226441 | Background | Palmer GM, Pirakalathanan P, Skinner AV. A multi-centre multi-national survey of anaesthetists regarding the range of anaesthetic and surgical practices for paediatric scoliosis surgery. Anaesth Intensive Care. 2010 Nov;38(6):1077-84. doi: 10.1177/0310057X1003800619. |
| 21982171 | Background | Ho CM, Wu HL, Ho ST, Wang JJ. Dexamethasone prevents postoperative nausea and vomiting: benefit versus risk. Acta Anaesthesiol Taiwan. 2011 Sep;49(3):100-4. doi: 10.1016/j.aat.2011.06.002. |
| 30765809 | Background | Wakamiya R, Seki H, Ideno S, Ihara N, Minoshima R, Watanabe K, Sato Y, Morisaki H. Effects of prophylactic dexamethasone on postoperative nausea and vomiting in scoliosis correction surgery: a double-blind, randomized, placebo-controlled clinical trial. Sci Rep. 2019 Feb 14;9(1):2119. doi: 10.1038/s41598-019-38764-8. |
| 19106333 | Background | Kloth DD. New pharmacologic findings for the treatment of PONV and PDNV. Am J Health Syst Pharm. 2009 Jan 1;66(1 Suppl 1):S11-8. doi: 10.2146/ashp080462. |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006575 | Heterocyclic Compounds, 3-Ring |