NCT04069078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 10, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2020

Completed
Last Updated

March 3, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

August 23, 2019

Last Update Submit

March 2, 2020

Conditions

BradycardiaSpinal Anesthetics Causing Adverse Effects in Therapeutic UseCesarean Section Complications

Outcome Measures

Primary Outcomes (1)

  • Bradycardia

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

    intraoperative

Study Arms (2)

Hyoscine butylbromide

ACTIVE COMPARATOR
Drug: Hyoscine Butylbromide 20 Mg/mL Solution for Injection Ampoule

Control

PLACEBO COMPARATOR
Other: Normal saline

Interventions

Hyoscine Butylbromide 20 Mg/mL Solution for Injection AmpouleDRUG

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

Hyoscine butylbromide
Normal salineOTHER

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

Control

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University hospital

Asyut, Asyut Governorate, 11111, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 35448942DERIVED

MeSH Terms

Conditions

Bradycardia

Interventions

Butylscopolammonium BromideSolutionsSaline Solution

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium CompoundsAminesOrganic ChemicalsScopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingPharmaceutical PreparationsCrystalloid SolutionsIsotonic Solutions

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor of anesthesia

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

October 10, 2019

Primary Completion

February 25, 2020

Study Completion

February 25, 2020

Last Updated

March 3, 2020

Record last verified: 2020-03

Locations

EG(1)