search
Back to results

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

Primary Purpose

Vomiting

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Hyoscine N Butylbromide
Ondansetron
Saline
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vomiting

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Assiut University hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

buscopan

ondansetron

control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

intraoperative nausea and vomiting
the incidence of intraoperative all emesis

Secondary Outcome Measures

Full Information

First Posted
March 3, 2021
Last Updated
March 15, 2023
Sponsor
Assiut University
search

1. Study Identification

Unique Protocol Identification Number
NCT04785118
Brief Title
Hyoscine Butyl-bromide Versus Ondansetron for Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia
Official Title
Hyoscine Butyl-bromide Versus Ondansetron for Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 12, 2022 (Actual)
Study Completion Date
December 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
buscopan
Arm Type
Active Comparator
Arm Description
Patients will receive IV hyoscine butyl-bromide 20 mg in 2 ml, just before spinal anaesthesia.
Arm Title
ondansetron
Arm Type
Active Comparator
Arm Description
Patients will receive IV ondansetron 4 mg in 2 ml, just before spinal anaesthesia.
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
Patients will receive 2 ml of IV normal saline as a placebo just before spinal anaesthesia.
Intervention Type
Drug
Intervention Name(s)
Hyoscine N Butylbromide
Intervention Description
Patients will receive IV hyoscine butyl-bromide 20 mg in 2 ml, just before spinal anaesthesia.
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Description
Patients received IV ondansetron 4 mg in 2 ml, just before spinal anaesthesia.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Patients received 2 ml of IV normal saline as a placebo just before spinal anaesthesia.
Primary Outcome Measure Information:
Title
intraoperative nausea and vomiting
Description
the incidence of intraoperative all emesis
Time Frame
intraoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Assiut University hospital
City
Assiut
ZIP/Postal Code
11111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs