Palonosetron vs Ondansetron In PONV Prophylaxis Among Idiopathic Scoliosis Patients

Sponsor

University of Malaya (Other)

Overall Status

Recruiting

CT.gov ID

NCT05956899

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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:

How effective is palonosetron compared to ondansetron, 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 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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Scoliosis Postoperative Nausea and Vomiting	Drug: Palonosetron Drug: Ondansetron	Phase 4

Detailed Description

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 74 participants. 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Comparison Between Palonosetron And Ondansetron As Prophylaxis Against Postoperative Nausea and Vomiting In Idiopathic Scoliosis Surgery: A Randomised Trial

Actual Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A Group A will receive a stat dose of IV palonosetron 1.5mcg/kg prior to commencement of general anaesthesia.	Drug: Palonosetron IV palonosetron 1.5mcg/kg prior to commencement of general anaesthesia
Active Comparator: Group B Group B will receive a stat dose of IV ondansetron 0.15mg/kg at the start of wound closure.	Drug: Ondansetron IV ondansetron 0.15mg/kg at the start of wound closure

Arm

Intervention/Treatment

Experimental: Group A

Group A will receive a stat dose of IV palonosetron 1.5mcg/kg prior to commencement of general anaesthesia.

Drug: Palonosetron

IV palonosetron 1.5mcg/kg prior to commencement of general anaesthesia

Active Comparator: Group B

Group B will receive a stat dose of IV ondansetron 0.15mg/kg at the start of wound closure.

Drug: Ondansetron

IV ondansetron 0.15mg/kg at the start of wound closure

Outcome Measures

Primary Outcome Measures

Incidence of PONV [At 1 hour after surgery]
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.
Incidence of PONV [At 4 hours after surgery]
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.
Incidence of PONV [At 12 hours after surgery]
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.
Incidence of PONV [At 24 hours after surgery]
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.
Incidence of PONV [At 48 hours after surgery]
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.

Secondary Outcome Measures

Number of Participants Developing Postoperative Nausea Vomiting Requiring Rescue Antiemetic Within 48 hours After Surgery [At 1 hour, 4 hours, 12 hours, 24 hours and 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.
Number of Participants Developing Adverse Effects Related to the Study Drugs. [Overall, assessed at 48 hours after surgery]
Such as headache, dizziness and constipation
Degree of patient satisfaction as represented on the Visual Analogue Scale [Overall, assessed at 48 hours after surgery]
On a scale of 1 (least satisfied) to 5 (most satisfied)

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age of 10 years and above
American Society of Anaesthesiologists (ASA) I-II Physical Status

Exclusion Criteria:

History of allergy to serotonin receptor antagonists or dexamethasone
Obesity with a body mass index (BMI) of 34 and above
Body weight of less than 30kg
Active smoker
History of gastroesophageal reflux disease/ other gastrointestinal diseases associated with vomiting
History of motion sickness
History of nausea or vomiting within 24 hours before the surgery
Administration of antiemetics/ steroids/ psychoactive medications within 24 hours before the surgery
Require mechanical ventilation postoperatively
History of cardiac arrhythmias
Prolonged QT (QTc is prolonged if > 440ms in men or > 460ms in women