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

Sponsor

Assiut University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04785118

Collaborator

(none)

165

Enrollment

Location

Arms

Anticipated Duration (Months)

16.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vomiting	Drug: Hyoscine N Butylbromide Drug: Ondansetron Drug: Saline	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

165 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: buscopan Patients will receive IV hyoscine butyl-bromide 20 mg in 2 ml, just before spinal anaesthesia.	Drug: Hyoscine N Butylbromide Patients will receive IV hyoscine butyl-bromide 20 mg in 2 ml, just before spinal anaesthesia.
Active Comparator: ondansetron Patients will receive IV ondansetron 4 mg in 2 ml, just before spinal anaesthesia.	Drug: Ondansetron Patients received IV ondansetron 4 mg in 2 ml, just before spinal anaesthesia.
Placebo Comparator: control Patients will receive 2 ml of IV normal saline as a placebo just before spinal anaesthesia.	Drug: Saline Patients received 2 ml of IV normal saline as a placebo just before spinal anaesthesia.

Arm

Intervention/Treatment

Active Comparator: buscopan

Patients will receive IV hyoscine butyl-bromide 20 mg in 2 ml, just before spinal anaesthesia.

Drug: Hyoscine N Butylbromide

Patients will receive IV hyoscine butyl-bromide 20 mg in 2 ml, just before spinal anaesthesia.

Active Comparator: ondansetron

Patients will receive IV ondansetron 4 mg in 2 ml, just before spinal anaesthesia.

Drug: Ondansetron

Patients received IV ondansetron 4 mg in 2 ml, just before spinal anaesthesia.

Placebo Comparator: control

Patients will receive 2 ml of IV normal saline as a placebo just before spinal anaesthesia.

Drug: Saline

Patients received 2 ml of IV normal saline as a placebo just before spinal anaesthesia.

Outcome Measures

Primary Outcome Measures

intraoperative nausea and vomiting [intraoperative]
the incidence of intraoperative all emesis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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 β-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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University hospital	Assiut		Egypt	11111

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mostafa Samy Abbas, associate professor of anesthesia, Assiut University

ClinicalTrials.gov Identifier:

NCT04785118

Other Study ID Numbers:

Hyoscine vs Ondansetrone

First Posted:

Mar 5, 2021

Last Update Posted:

Oct 6, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Vomiting

Scopolamine

Ondansetron

Butylscopolammonium Bromide

Study Results

No Results Posted as of Oct 6, 2021