Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04785118
Status:
COMPLETED
Last Update Posted:
2023-03-16
First Post:
2021-03-03
Brief Title:
Hyoscine Butyl-bromide Versus Ondansetron for Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Hyoscine Butyl-bromide Versus Ondansetron for Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
overall incidence of intraoperative nausea and vomitingIONV during regional anesthesia for cesarean section is extremely variable up to 80 percent depending on the anesthetic technique used spinal epidural or combined spinal-epidural and on the preventive and therapeutic measures taken1 Spinal anesthesia for CS is safe and effective it is currently the anesthetic technique of choice for elective Cesarean delivery CD However maternal hypotension associated with spinal anesthesia is one of the primary causes of intraoperative nausea andor vomiting IONV this symptom is thought to be caused by cerebral and gut hypoperfusion that stimulate the vomiting centre in the brainstem and cause serotonin release respectively2 3 While bolus dosing of phenylephrine effectively treats maternal hypotension it does not prevent intraoperative maternal nausea which may be associated with established hypotension and this may adversely affect patient satisfaction4 5 However the unopposed vagal activity that occurs with sympathetic block might be another cause of intraoperative nausea and vomiting during spinal anesthesia6
Both scopolamine and atropine are tertiary amines which cross the blood-brain barrier with central side effects such as confusion sedation or paradoxical excitation However Hyoscine butyl bromide HBB has a quaternary ammonium structure that does not cross through the blood-brain barrier and also with lower placental transfer than atropine making it more suitable for use in pregnancy 7 8
Hyoscine Butyl-bromide also known as scopolamine butyl-bromide and sold under the brand name Buscopan9 Despite being a quaternary ammonium compound HBB is still capable of targeting the chemoreceptor trigger zone due to the lack of a well-developed blood-brain-barrier in the medulla oblongata which potentiates the antiemetic effects that it produces through local action on the smooth muscle of the gastrointestinal tract10
So the aim of the current study is to examine the effect of prophylactic use of HBB and Ondansetron to decrease the incidence of intraoperative bradycardia and thus intraoperative nausea and vomiting in parturients undergoing CD under spinal anaesthesia
Both scopolamine and atropine are tertiary amines which cross the blood-brain barrier with central side effects such as confusion sedation or paradoxical excitation However Hyoscine butyl bromide HBB has a quaternary ammonium structure that does not cross through the blood-brain barrier and also with lower placental transfer than atropine making it more suitable for use in pregnancy 7 8
Hyoscine Butyl-bromide also known as scopolamine butyl-bromide and sold under the brand name Buscopan9 Despite being a quaternary ammonium compound HBB is still capable of targeting the chemoreceptor trigger zone due to the lack of a well-developed blood-brain-barrier in the medulla oblongata which potentiates the antiemetic effects that it produces through local action on the smooth muscle of the gastrointestinal tract10
So the aim of the current study is to examine the effect of prophylactic use of HBB and Ondansetron to decrease the incidence of intraoperative bradycardia and thus intraoperative nausea and vomiting in parturients undergoing CD under spinal anaesthesia
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None