Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT04785118
Status:
COMPLETED
Last Update Posted:
2023-03-16
First Post:
2021-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hyoscine Butyl-bromide Versus Ondansetron for Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia
Sponsor:
Assiut University
Organization:
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 vomiting(IONV) 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 taken.1 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 and/or 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, respectively.2, 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 satisfaction.4, 5 However, the unopposed vagal activity that occurs with sympathetic block might be another cause of intraoperative nausea and vomiting during spinal anesthesia.6
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 Buscopan.9 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 tract.10
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 Buscopan.9 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 tract.10
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?: