A Phase 4 interventional study of Hyoscine N Butylbromide and Ondansetron in Vomiting, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-03-16.
Sponsored by Assiut University · Phase 4, Interventional, and Prevention
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.
1,100 studies on the registry are indexed under Vomiting; 134 are open to participants now.
This study's enrollment of 165 is above the median of 107 across 935 interventional studies indexed under Vomiting.
Browse Vomiting studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
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Exclusion Criteria:
Patients will receive IV hyoscine butyl-bromide 20 mg in 2 ml, just before spinal anaesthesia.
Drug: Hyoscine N Butylbromide
Patients will receive IV ondansetron 4 mg in 2 ml, just before spinal anaesthesia.
Drug: Ondansetron
Patients will receive 2 ml of IV normal saline as a placebo just before spinal anaesthesia.
Drug: Saline
Patients will receive IV hyoscine butyl-bromide 20 mg in 2 ml, just before spinal anaesthesia.
Patients received IV ondansetron 4 mg in 2 ml, just before spinal anaesthesia.
Patients received 2 ml of IV normal saline as a placebo just before spinal anaesthesia.
intraoperative nausea and vomiting
the incidence of intraoperative all emesis
Time frame: intraoperative
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Assiut University