Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540885
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-10
Brief Title:
A Comparison Between Palonosetron Versus Granisetron as PONV Prophylaxis in Scoliotic Patients Undergoing Spine Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Comparison Between Palonosetron Versus Granisetron As Postoperative Nausea and Vomiting Prophylaxis In Idiopathic Scoliosis Surgery A Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PONV
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
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
Detailed Description:
Postoperative nausea and vomiting PONV remains a common adverse event after surgery and anaesthesia causing much dissatisfaction among patients PONV incidence is reported at 30 in all surgical patients and up to 80 in high-risk patients Idiopathic scoliosis is a common form of structural spinal deformities with a Cobb angle of 10 degrees It affects young females in the early pubertal stage more than young men by 1 and 4
Posterior spinal fusion PSF surgery is commonly performed in patients with severe scoliosis It is a long complex surgery inflicting extensive surgical field requiring opioids as the mainstay of analgesia during the perioperative period These targeted population are particularly adolescent female requiring intraoperative and postoperative opioids who are at high risk of developing PONV
Dexamethasone and anti-serotonergic drugs like granisetron are commonly used antiemetics due to their efficacy and safety profiles Dexamethasone is particularly favoured 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 anaesthesia TIVA is recommended for high-risk PONV patients as it reduces the emetogenic effect of volatile anaesthetics 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 University 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 PSF 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 anaesthetic 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
Posterior spinal fusion PSF surgery is commonly performed in patients with severe scoliosis It is a long complex surgery inflicting extensive surgical field requiring opioids as the mainstay of analgesia during the perioperative period These targeted population are particularly adolescent female requiring intraoperative and postoperative opioids who are at high risk of developing PONV
Dexamethasone and anti-serotonergic drugs like granisetron are commonly used antiemetics due to their efficacy and safety profiles Dexamethasone is particularly favoured 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 anaesthesia TIVA is recommended for high-risk PONV patients as it reduces the emetogenic effect of volatile anaesthetics 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 University 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 PSF 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 anaesthetic 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None