A Comparison Between Palonosetron Versus Granisetron as PONV Prophylaxis in Scoliotic Patients Undergoing Spine Surgery

NCT06540885 | Recruiting Phase 4 DMC

• 1 other identifier: 202464-13794
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this clinical trial is to compare the effectiveness of two Serotonin (5- HT3) receptor antagonist, palonosetron and granisetron, administered along with dexamethasone as a preventive measure against early and delayed postoperative nausea and vomiting (PONV) in adult and adolescent patients with idiopathic scoliosis (IS) undergoing posterior spinal fusion (PSF) surgery under total intravenous anesthesia (TIVA). The main questions the study aims to answer are: How effective is palonosetron compared to granisetron, when both combined with dexamethasone, in preventing PONV after scoliosis surgery? Are there any differences in the need for rescue antiemetics, occurrence of adverse effects related to the study drugs, and patient satisfaction between the two treatment groups? Participants in the study will be randomly assigned to receive either palonosetron or granisetron 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.

Conditions

Postoperative Nausea and Vomiting; Scoliosis

Keywords

Antiemetics; Granisetron; Palonosetron

Outcome Measures

Primary Outcomes (5)

• Incidence of postoperative nausea and vomiting (PONV) delayed postoperative nausea and vomiting (PONV) in adult and adolescent idiopathic scoliosis patients

  To compare the effectiveness of palonosetron and granisetron 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 postoperative nausea and vomiting (PONV)

  To compare the effectiveness of palonosetron and granisetron 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 postoperative nausea and vomiting (PONV)

  To compare the effectiveness of palonosetron and granisetron 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 postoperative nausea and vomiting (PONV)

  To compare the effectiveness of palonosetron and granisetron 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 postoperative nausea and vomiting (PONV)

  To compare the effectiveness of palonosetron and granisetron 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 48 hours after surgery

Secondary Outcomes (3)

• To evaluate the need for rescue antiemetics among participants

  At 1 hour, 4 hours, 12 hours, 24 hours and 48 hours after surgery

• To evaluate the adverse effects related to the study drugs.

  At 1 hour, 4 hours, 12 hours, 24 hours and 48 hours after surgery

• To assess the degree of participant's satisfaction.

  At 48 hours after surgery

Study Arms (2)

Palonosetron Group (Group P)

EXPERIMENTAL

Group P will receive a stat dose of IV palonosetron 1.5mcg/kg diluted in a 5ml preparation of normal saline 0.9% prior to the commencement of general anaesthesia. At the start of wound closure, Group P will receive a 5ml preparation of normal saline 0.9% as a placebo.

Drug: Palonosetron (Group P)

Granisetron Group (Group G)

ACTIVE COMPARATOR

Group G will receive a 5ml preparation of normal saline 0.9% as placebo prior to commencement of general anaesthesia. At the start of wound closure, a stat dose of IV granisetron 1mg in 5ml preparation will be administered.

Drug: Granisetron (Group G)

Interventions

Palonosetron (Group P) DRUG

Group P will be receiving palonosetron 1.5mcg/kg before the commencement of general anaesthesia

Also known as: antiemetic

Palonosetron Group (Group P)

Granisetron (Group G) DRUG

Group G participants will receive IV Granisetron 1mg at the start of wound closure

Also known as: antiemetic

Granisetron Group (Group G)

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 10 years and above
• American Society of Anesthesiologists (ASA) class I-II

You may not qualify if:

• Active smoker
• Obesity with body mass index (BMI) of 34 and above
• Body weight of less than 30kg
• History of gastro-esophageal reflux disease (GERD)/ other gastrointestinal diseases associated with vomiting
• History of motion sickness
• History of allergy to 5-HT3 (serotonin) receptor antagonists or dexamethasone
• History of nausea or vomiting withing 24 hours before surgery
• History of administration of antiemetics/ steroids/ psychoactive medications within 24 hours before the surgery
• History of cardiac arrhythmias
• Prolonged QT (QTc is prolonged if \> 430ms in men or \>450ms in women)

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (2)

University Malaya

Pantai Valley, Kuala Lumpur, 59100, Malaysia

RECRUITING

University Malaya Medical Centre

Kuala Lumpur, 50603, Malaysia

RECRUITING

Related Publications (8)

• Cao X, White PF, Ma H. An update on the management of postoperative nausea and vomiting. J Anesth. 2017 Aug;31(4):617-626. doi: 10.1007/s00540-017-2363-x. Epub 2017 Apr 28.

  PMID: 28455599 RESULT

• Johansson E, Hultin M, Myrberg T, Wallden J. Early post-operative nausea and vomiting: A retrospective observational study of 2030 patients. Acta Anaesthesiol Scand. 2021 Oct;65(9):1229-1239. doi: 10.1111/aas.13936. Epub 2021 Jul 4.

  PMID: 34086350 RESULT

• Cheng JC, Castelein RM, Chu WC, Danielsson AJ, Dobbs MB, Grivas TB, Gurnett CA, Luk KD, Moreau A, Newton PO, Stokes IA, Weinstein SL, Burwell RG. Adolescent idiopathic scoliosis. Nat Rev Dis Primers. 2015 Sep 24;1:15030. doi: 10.1038/nrdp.2015.30.

  PMID: 27188385 RESULT

• Schraag S, Pradelli L, Alsaleh AJO, Bellone M, Ghetti G, Chung TL, Westphal M, Rehberg S. Propofol vs. inhalational agents to maintain general anaesthesia in ambulatory and in-patient surgery: a systematic review and meta-analysis. BMC Anesthesiol. 2018 Nov 8;18(1):162. doi: 10.1186/s12871-018-0632-3.

  PMID: 30409186 RESULT

• Schaefer MS, Kranke P, Weibel S, Kreysing R, Kienbaum P. Total intravenous anaesthesia versus single-drug pharmacological antiemetic prophylaxis in adults: A systematic review and meta-analysis. Eur J Anaesthesiol. 2016 Oct;33(10):750-60. doi: 10.1097/EJA.0000000000000520.

  PMID: 27454663 RESULT

• 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.

  PMID: 32467512 RESULT

• Marret E, Kurdi O, Zufferey P, Bonnet F. Effects of nonsteroidal antiinflammatory drugs on patient-controlled analgesia morphine side effects: meta-analysis of randomized controlled trials. Anesthesiology. 2005 Jun;102(6):1249-60. doi: 10.1097/00000542-200506000-00027.

  PMID: 15915040 RESULT

• Elia N, Lysakowski C, Tramer MR. Does multimodal analgesia with acetaminophen, nonsteroidal antiinflammatory drugs, or selective cyclooxygenase-2 inhibitors and patient-controlled analgesia morphine offer advantages over morphine alone? Meta-analyses of randomized trials. Anesthesiology. 2005 Dec;103(6):1296-304. doi: 10.1097/00000542-200512000-00025.

  PMID: 16306743 RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Scoliosis

Interventions

Palonosetron; Antiemetics; Granisetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Gastrointestinal Agents; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Bridged Bicyclo Compounds, Heterocyclic

Study Officials

• Nantni Kumaran, MBBS

  University of Malaya

  PRINCIPAL INVESTIGATOR

• Mohd Shahnaz Hasan, MAnaes, MBBS

  University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenlee Liew, MBBS

CONTACT

+60195753579; drkenliew@gmail.com

Siti Nadzrah Yunus, MAnaes, MBBS

CONTACT

+60176975009; siti.nadzrah@ummc.edu.my

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All the anaesthesiologists and patients involved in the study were blinded to group allotment. Patient allotment will be revealed prior to the surgery via the sealed envelope to an anaesthetic nurse or doctor (who is not involved in study) for drug preparation. Participants will receive 2 separate injections of the study drugs/placebo. The first injection given prior to commencement of general anaesthesia comprises of palonosetron 1.5mcg/kg (maximum dose of 75mcg) diluted with normal saline 0.9% to make up a 5ml preparation (for Group P), or a 5ml preparation of normal saline 0.9% as placebo (for Group G). The second injection will be administered at the start of wound closure, comprising either 5ml of preparation of normal saline 0.9% as placebo (for Group P), or IV Granisetron 1mg diluted into a 5ml preparation of normal saline 0.9% for Group G.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 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 Palonosetron Group (Group P) and Granisetron Group (Group G). Group P will receive Intravenous (IV) palonosetron 1.5mcg/kg prior to the commencement of general anaesthesia; while Group G) will receive IV granisetron 1mg at the start of wound closure.

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: August 6, 2024
• Study Start: January 6, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)