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

NCT04785118 | Completed Phase 4

• 1 other identifier: Hyoscine vs Ondansetrone
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Vomiting

Outcome Measures

Primary Outcomes (1)

• intraoperative nausea and vomiting

  the incidence of intraoperative all emesis

  intraoperative

Study Arms (3)

buscopan

ACTIVE COMPARATOR

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

Drug: Hyoscine N Butylbromide

ondansetron

ACTIVE COMPARATOR

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

Drug: Ondansetron

control

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

Hyoscine N Butylbromide DRUG

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

buscopan

Ondansetron DRUG

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

ondansetron

Saline DRUG

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

control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University hospital

Asyut, 11111, Egypt

Location

MeSH Terms

Conditions

Vomiting

Interventions

Butylscopolammonium Bromide; Ondansetron; Sodium Chloride

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of anesthesia

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 5, 2021
• Study Start: October 1, 2021
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

EG (1)