Status:
COMPLETED
Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section
Lead Sponsor:
Assiut University
Conditions:
Bradycardia
Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2020
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT04069078
Start Date
October 10 2019
End Date
February 25 2020
Last Update
March 3 2020
Active Locations (1)
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1
Assiut University hospital
Asyut, Asyut Governorate, Egypt, 11111