Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06297499
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-13
Brief Title:
Ondansetron Use for Preventing Pruritus In Patients Undergoing Cesarean Section
Sponsor:
Wayne State University
Organization:
Wayne State University
Study Overview
Official Title:
Timing of Ondansetron Use for Maximum Efficacy in Preventing Pruritus In Patients Undergoing Cesarean Section Under Spinal Anesthesia With Preservative Free Morphine
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
Opioids are often added with a local anesthetic to enhance the duration and quality of spinal anesthesia for cesarean delivery patients However spinal opioids are associated with a wide variety of side effects such as nausea vomiting NV and pruritus itching The occurrence of pruritus can vary between 30 and 100 making pruritus the most common side-effect of intrathecal opioids and this rate is even higher in pregnant patients Pruritus may require treatment which can be ineffective or sometimes reverse the analgesic effect of the opioids Ondansetron is a safe and very commonly used Serotonin receptor antagonist treatment for local anesthetic opioid-induced pruritus used in pregnancy The effect of different administration times of ondansetron in reducing pruritus or NV in cesarean section CS cases has not been extensively studied and thus this prospective study can help guide future clinical management of side effects caused by spinal intrathecal morphine administration
Detailed Description:
Opioids are often added with a local anesthetic to enhance the duration and quality of spinal anesthesia for cesarean delivery patients However spinal opioids are associated with a wide variety of side effects such as nausea vomiting NV and pruritus itching The occurrence of pruritus can vary between 30 and 100 making pruritus the most common side-effect of intrathecal opioids and this rate is even higher in pregnant patients Pruritus may require treatment which can be ineffective or sometimes reverse the analgesic effect of the opioids Ondansetron is a safe and very commonly used Serotonin receptor antagonist treatment for local anesthetic opioid-induced pruritus used in pregnancy The effect of different administration times of ondansetron in reducing pruritus or NV in cesarean section CS cases has not been extensively studied and thus this prospective study can help guide future clinical management of side effects caused by spinal intrathecal morphine administration
The primary aim of this study is to observe in a randomized double-blinded trial if the timing of prophylactic administration of intravenous ondansetron can reduce the incidence and severity of intrathecal morphine-induced pruritus in patients undergoing Cesarean section CS The secondary aim is to establish the effect of intravenous ondansetron given at different time intervals following CS for postoperative nausea and vomiting PONV The primary study hypothesis is that patients receiving prophylactic intravenous ondansetron 15-30 minutes prior to intrathecal morphine will experience a lower incidence and severity of intrathecal morphine-induced pruritus than patients receiving ondansetron administered at the time of umbilical cord clamping The secondary study hypothesis is that CS patients receiving intravenous ondansetron 15-30 minutes prior to intrathecal morphine will have less nausea and vomiting than patients receiving ondansetron administered at the time of umbilical cord clamping
As the effect of prophylactic administration of ondansetron in reducing pruritus or NauseaVomiting in cesarean section CS cases has not been studied and thus this prospective study may help guide future clinical management of side effects caused by intrathecal morphine administration
The primary aim of this study is to observe in a randomized double-blinded trial if the timing of prophylactic administration of intravenous ondansetron can reduce the incidence and severity of intrathecal morphine-induced pruritus in patients undergoing Cesarean section CS The secondary aim is to establish the effect of intravenous ondansetron given at different time intervals following CS for postoperative nausea and vomiting PONV The primary study hypothesis is that patients receiving prophylactic intravenous ondansetron 15-30 minutes prior to intrathecal morphine will experience a lower incidence and severity of intrathecal morphine-induced pruritus than patients receiving ondansetron administered at the time of umbilical cord clamping The secondary study hypothesis is that CS patients receiving intravenous ondansetron 15-30 minutes prior to intrathecal morphine will have less nausea and vomiting than patients receiving ondansetron administered at the time of umbilical cord clamping
As the effect of prophylactic administration of ondansetron in reducing pruritus or NauseaVomiting in cesarean section CS cases has not been studied and thus this prospective study may help guide future clinical management of side effects caused by intrathecal morphine administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None