Hyoscine Butyl-bromide Versus Ondansetron for Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia

Vomiting Clinical Trial

Official title:

Hyoscine Butyl-bromide Versus Ondansetron for Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04785118
• Other study ID #: Hyoscine vs Ondansetrone
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2021
• Est. completion date: December 12, 2022

Study information

• Verified date: March 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: December 12, 2022
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• All patients 18-40 years of age,

• American Society of Anaesthesiologists (ASA) classification class I and II

• patients scheduled for elective or semi-elective surgery (category 3 and 4 Caesarean section) under spinal anaesthesia

• Single baby pregnancy of more than 32 weeks

Exclusion Criteria:

• height < 150 or > 180 cm,

• Body mass index (BMI) >35 kg m-2,

• Contraindication or refusal to undergo regional anaesthesia,

• any cardiovascular disease including arrhythmias, Patients on ß-adrenergic blockers or any drugs that may alter the normal response to the study drug,

• history of PONV or motion sickness,

• had taken antiemetic medication in the previous week,

• had a history of hyperemesis gravidarum

Related Conditions & MeSH terms

• Vomiting

Intervention

Drug:
• Hyoscine N Butylbromide
Patients will receive IV hyoscine butyl-bromide 20 mg in 2 ml, just before spinal anaesthesia.
• Ondansetron
Patients received IV ondansetron 4 mg in 2 ml, just before spinal anaesthesia.
• Saline
Patients received 2 ml of IV normal saline as a placebo just before spinal anaesthesia.

Locations

Country	Name	City	State
Egypt	Assiut University hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative nausea and vomiting	the incidence of intraoperative all emesis	intraoperative