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Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section

A

Assiut University

Status and phase

Completed
Phase 4

Conditions

Bradycardia
Cesarean Section Complications
Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Treatments

Drug: Hyoscine Butylbromide 20 Mg/mL Solution for Injection Ampoule
Other: Normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT04069078
hyoscine

Details and patient eligibility

About

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.

Enrollment

173 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

173 participants in 2 patient groups, including a placebo group

Hyoscine butylbromide
Active Comparator group
Treatment:
Drug: Hyoscine Butylbromide 20 Mg/mL Solution for Injection Ampoule
Control
Placebo Comparator group
Treatment:
Other: Normal saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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