Back to resultsHyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section
Primary Purpose
Bradycardia, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, Cesarean Section Complications
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Hyoscine Butylbromide 20 Mg/mL Solution for Injection Ampoule
Normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Bradycardia
Eligibility Criteria
Inclusion Criteria:
- ASA physical status class I-II.
- Age: 18 Years to 40 Years.
- Women scheduled for elective Cesarean section under spinal anesthesia.
- indications for CS other than fetal or maternal pathology.
Exclusion Criteria:
- Height < 150 or > 180 cm
- Body mass index (BMI) >35 kg/m2
- Contraindication for central neuraxial block
- Refusal to undergo regional anesthesia
- Known allergy to any of the study drugs,
- Infection at the site of injection,
- Coagulopathy,
- Indication to general anesthesia
- Baseline bradycardia (heart rate < 60/min), or any cardiovascular disease
- Patients taking β-adrenergic blockers or any drugs that may alter normal response to study drugs.
- Arrhythmia such as atrial fibrillation, supraventricular tachycardia, heart block greater than first degree, left bundle branch block,
- Hypertension (systolic blood pressure more than 140 mm Hg or diastolic blood pressure more than 90 mm Hg), unstable angina or cardiomyopathy,
- Associated medical problem with pregnancy (as hypertension, diabetes mellitus, hepatic impairment or renal impairment)
Sites / Locations
- Assiut University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Hyoscine butylbromide
Control
Arm Description
Outcomes
Primary Outcome Measures
Bradycardia
number of participants who will develop heart rate below 50 BPM.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04069078
Brief Title
Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section
Official Title
Prophylactic Use of Iv Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section Under Spinal Anaesthesia. a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
February 25, 2020 (Actual)
Study Completion Date
February 25, 2020 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to assess the efficacy of Iv hyoscine butylbromide in preventing Bradycardia during cesarean section under spinal anaesthesia with local anaesthetic and morphine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use, Cesarean Section Complications
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
173 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hyoscine butylbromide
Arm Type
Active Comparator
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Hyoscine Butylbromide 20 Mg/mL Solution for Injection Ampoule
Intervention Description
Patients will receive IV study solution which is hyoscine butylbromide 20 mg in 1 ml one minute after spinal anaesthesia
Intervention Type
Other
Intervention Name(s)
Normal saline
Intervention Description
Patients will receive 1 ml of IV normal saline as a placebo one minute after spinal anesthesia
Primary Outcome Measure Information:
Title
Bradycardia
Description
number of participants who will develop heart rate below 50 BPM.
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:
ASA physical status class I-II.
Age: 18 Years to 40 Years.
Women scheduled for elective Cesarean section under spinal anesthesia.
indications for CS other than fetal or maternal pathology.
Exclusion Criteria:
Height < 150 or > 180 cm
Body mass index (BMI) >35 kg/m2
Contraindication for central neuraxial block
Refusal to undergo regional anesthesia
Known allergy to any of the study drugs,
Infection at the site of injection,
Coagulopathy,
Indication to general anesthesia
Baseline bradycardia (heart rate < 60/min), or any cardiovascular disease
Patients taking β-adrenergic blockers or any drugs that may alter normal response to study drugs.
Arrhythmia such as atrial fibrillation, supraventricular tachycardia, heart block greater than first degree, left bundle branch block,
Hypertension (systolic blood pressure more than 140 mm Hg or diastolic blood pressure more than 90 mm Hg), unstable angina or cardiomyopathy,
Associated medical problem with pregnancy (as hypertension, diabetes mellitus, hepatic impairment or renal impairment)
Facility Information:
Facility Name
Assiut University hospital
City
Assiut
State/Province
Asyut Governorate
ZIP/Postal Code
11111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35448942
Citation
Abbas MS, Hassan SA, Abbas AM, Thabet AM, Thabet AM, Mahdy MM. Hemodynamic and antiemetic effects of prophylactic hyoscine butyl-bromide during cesarean section under spinal anesthesia: a randomized controlled trial. BMC Anesthesiol. 2022 Apr 21;22(1):112. doi: 10.1186/s12871-022-01659-9.
Results Reference
derived
Learn more about this trial
Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section
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