Skip to main content
OpenTrials
Completed

NCT Number: NCT04069078

Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Cesarean Section Complications Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Assiut University hospital

Asyut, Asyut Governorate, 11111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hyoscine Butylbromide 20 Mg/mL Solution for Injection Ampoule

Drug

Patients will receive IV study solution which is hyoscine butylbromide 20 mg in 1 ml one minute after spinal anaesthesia

Normal Saline

Other

Patients will receive 1 ml of IV normal saline as a placebo one minute after spinal anesthesia

Primary outcomes

  1. Bradycardia

    Time frame: intraoperative

    number of participants who will develop heart rate below 50 BPM.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Prophylactic Use of Iv Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section Under Spinal Anaesthesia. a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 28, 2019
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.