Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section
Phase 4
Completed
- Conditions
- BradycardiaSpinal Anesthetics Causing Adverse Effects in Therapeutic UseCesarean Section Complications
- Interventions
- Other: Normal saline
- Registration Number
- NCT04069078
- Lead Sponsor
- Assiut University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 173
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hyoscine butylbromide Hyoscine Butylbromide 20 Mg/mL Solution for Injection Ampoule - Control Normal saline -
- Primary Outcome Measures
Name Time Method Bradycardia intraoperative number of participants who will develop heart rate below 50 BPM.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Hyoscine Butylbromide's anticholinergic effects in preventing spinal anesthesia-induced bradycardia?
How does prophylactic Hyoscine Butylbromide compare to atropine or glycopyrrolate in managing bradycardia during cesarean sections?
Which biomarkers correlate with autonomic response to anticholinergics in spinal anesthesia for cesarean delivery?
What are the safety profiles and management strategies for Hyoscine Butylbromide adverse events in obstetric populations?
Are there alternative anticholinergic agents or combination therapies for bradycardia prevention in spinal anesthesia trials?
Trial Locations
- Locations (1)
Assiut University hospital
🇪🇬Assiut, Asyut Governorate, Egypt
Assiut University hospital🇪🇬Assiut, Asyut Governorate, Egypt