Rocuronium vs Cis-atracurium: Do Rocuronium Still 'ROCKS'... | NCT06102915

Studies
Rocuronium vs Cis-atracurium: Do Rocuronium Still 'ROCKS' In Coronary Artery Bypass Grafting

NCT06102915

Sponsor

Institut Jantung Negara

Status

Completed

Last Update Posted

Nov 28, 2023Actual

Enrollment

289Actual

Phase

Not provided

Conditions

Neuromuscular Blockade
Postoperative Pulmonary Atelectasis
Postoperative Pulmonary Complication
Coronary Artery Disease
Coronary Artery Bypass Grafting
Hypothermic Cardiopulmonary Bypass

Interventions

Rocuronium Bromide 10 MG/ML
Nimbex 10 MG in 5 ML Injection

Countries

Malaysia

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

Status Module

Record Verification Date

Nov 2023

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

Aug 1, 2023Actual

Primary Completion Date

Nov 23, 2023Actual

Completion Date

Nov 23, 2023Actual

First Submitted Date

Oct 22, 2023

First Submission Date that Met QC Criteria

Oct 22, 2023

First Posted Date

Oct 26, 2023Actual

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

Nov 22, 2023

Last Update Posted Date

Nov 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The current trend in most cardiac surgeries was to use rocuronium as it provides faster recovery in train-of-four ratio compared to other aminosteroid non-depolarising neuromuscular blocker. However, as most cardiac centres' standard of care does not perform any neuromuscular monitoring nor antagonism of neuromuscular blockade effect, residual neuromuscular blockade could potentially be the key to delayed extubation. As such, Cis-atracurium's organ-independent Hofmann elimination could be in favour.

Detailed Description

Not provided

Conditions Module

Conditions

Neuromuscular Blockade
Postoperative Pulmonary Atelectasis
Postoperative Pulmonary Complication
Coronary Artery Disease
Coronary Artery Bypass Grafting
Hypothermic Cardiopulmonary Bypass

Keywords

Neuromuscular Blockade
Postoperative Pulmonary Atelectasis
postoperative pulmonary complication
Coronary Artery Disease
coronary artery bypass grafting
hypothermic cardiopulmonary bypass
rocuronium
cis-atracurium

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

289Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rocuronium		Rocuronium 1mg/kg to be given at induction of anaesthesia and another 1mg/kg would be given when the patient is on hypothermic cardiopulmonary bypass	Drug: Rocuronium Bromide 10 MG/ML
Cis-atracurium		Cis-atracurium 0.2mg/kg to be given at induction of anaesthesia and another 0.2mg/kg would be given when the patient is on hypothermic cardiopulmonary bypass	Drug: Nimbex 10 MG in 5 ML Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rocuronium Bromide 10 MG/ML	Drug	Comparative	Rocuronium	Esmeron

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of postoperative pulmonary complication	Which neuromuscular relaxant is associated with lesser postoperative pulmonary complication	6 months

Secondary Outcomes

Measure	Description	Time Frame
Ventilation hours in ICU	Ventilation hours from ICU admission from OR to extubation	6 months
Requirements for Non-invasive ventilation	NIV duration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients that undergo general anaesthesia for CABG surgery requiring neuromuscular blockade of either rocuronium or cis-atracurium

Exclusion Criteria:

Recent history of pulmonary infection four weeks before surgery
Exposed to both neuromuscular blockade within 24 hours perioperatively
Patients intubated or on tracheostomies pre-operatively
Any missing or incomplete data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients that undergo general anaesthesia for CABG surgery requiring neuromuscular blockade of either rocuronium or cis-atracurium

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
SONG LIN LOW, MBBS	IJN	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Jantung Negara		Kuala Lumpur		50400	Malaysia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12638566	Result	Thomas R, Smith D, Strike P. Prospective randomised double-blind comparative study of rocuronium and pancuronium in adult patients scheduled for elective 'fast-track' cardiac surgery involving hypothermic cardiopulmonary bypass. Anaesthesia. 2003 Mar;58(3):265-71. doi: 10.1046/j.1365-2044.2003.30362.x.
18603747	Result

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

ID	Term
D000077123	Rocuronium
C101584	cisatracurium
D007267	Injections

ID	Term
D000732	Androstanols
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics

ID	Term
D001261	Pulmonary Atelectasis
D003324	Coronary Artery Disease