Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04069078
• Other study ID #: hyoscine
• Status: Completed
• Phase: Phase 4
• Start date: October 10, 2019
• Est. completion date: February 25, 2020

Study information

• Verified date: March 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: February 25, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 ß-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)

Related Conditions & MeSH terms

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

Intervention

Drug:
• Hyoscine 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

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

Locations

Country	Name	City	State
Egypt	Assiut University hospital	Assiut	Asyut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

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