Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04069078

Enrollment

173

Registered

2019-08-28

Start date

2019-10-10

Completion date

2020-02-25

Last updated

2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGHyoscine Butylbromide 20 Mg/mL Solution for Injection Ampoule

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

OTHERNormal saline

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Bradycardia	intraoperative	number of participants who will develop heart rate below 50 BPM.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026