Hyoscine Butylbromide for Prevention of Bradycardia Durin... | NCT04069078

Studies
Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section

NCT04069078

Sponsor

Assiut University

Status

Completed

Last Update Posted

Mar 3, 2020Actual

Enrollment

173Actual

Phase

Phase 4

Conditions

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

Interventions

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

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 10, 2019Actual

Primary Completion Date

Feb 25, 2020Actual

Completion Date

Feb 25, 2020Actual

First Submitted Date

Aug 23, 2019

First Submission Date that Met QC Criteria

Aug 23, 2019

First Posted Date

Aug 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2020

Last Update Posted Date

Mar 3, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

173Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hyoscine butylbromide	Active Comparator		Drug: Hyoscine Butylbromide 20 Mg/mL Solution for Injection Ampoule
Control	Placebo Comparator		Other: Normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University hospital		Asyut	Asyut Governorate	11111	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35448942	Derived	Abbas MS, Hassan SA, Abbas AM, Thabet AM, Thabet AM, Mahdy MM. Hemodynamic and antiemetic effects of prophylactic hyoscine butyl-bromide during cesarean section under spinal anesthesia: a randomized controlled trial. BMC Anesthesiol. 2022 Apr 21;22(1):112. doi: 10.1186/s12871-022-01659-9.

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

ID	Term
D002086	Butylscopolammonium Bromide
D012996	Solutions
D000077330	Saline Solution

ID	Term
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals
D012602	Scopolamine Derivatives