Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section

Phase 4

Completed

• Conditions: Bradycardia; Spinal Anesthetics Causing Adverse Effects in Therapeutic Use; Cesarean Section Complications
• Interventions: Drug: Hyoscine Butylbromide 20 Mg/mL Solution for Injection Ampoule; 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

Study Timeline

• Study First Submitted: 2019-08-23
• Study First Submitted QC: 2019-08-23
• Study First Posted: 2019-08-28
• Study Start: 2019-10-10
• Primary Completion: 2020-02-25
• Study Completion: 2020-02-25
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-03

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.

Trial Locations

Locations (1)

Assiut University hospital; 🇪🇬 Assiut, Asyut Governorate, Egypt