Rocuronium vs Cis-atracurium: Do Rocuronium Still 'ROCKS' In Coronary Artery Bypass Grafting - A Retrospective Cohort Study

• Sponsor: Institut Jantung Negara (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06102915
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 27.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuromuscular Blockade; Postoperative Pulmonary Atelectasis; Postoperative Pulmonary Complication; Coronary Artery Disease; Coronary Artery Bypass Grafting; Hypothermic Cardiopulmonary Bypass	Drug: Rocuronium Bromide 10 MG/ML; Drug: Nimbex 10 MG in 5 ML Injection

Study Design

• Study Type: Observational
• Anticipated Enrollment: 250 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Rocuronium vs Cis-atracurium: Do Rocuronium Still 'ROCKS' In Coronary Artery Bypass Grafting - A Retrospective Cohort Study
• Actual Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
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; Comparative; Other Names: Esmeron
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; Comparative; Other Names: Cis-atracurium

Outcome Measures

Primary Outcome Measures

1. Incidence of postoperative pulmonary complication [6 months]

   Which neuromuscular relaxant is associated with lesser postoperative pulmonary complication

Secondary Outcome Measures

1. Ventilation hours in ICU [6 months]

   Ventilation hours from ICU admission from OR to extubation

2. Requirements for Non-invasive ventilation [6 months]

   NIV duration

3. Incidence of postoperative atrial fibrillation [6 months]

   Incidence of postoperative atrial fibrillation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

1. Recent history of pulmonary infection four weeks before surgery

2. Exposed to both neuromuscular blockade within 24 hours perioperatively

3. Patients intubated or on tracheostomies pre-operatively

4. Any missing or incomplete data

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Jantung Negara	Kuala Lumpur		Malaysia	50400

Sponsors and Collaborators

• Institut Jantung Negara

Investigators

• Principal Investigator: SONG LIN LOW, MBBS, IJN

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SONG LIN LOW, Dr, Institut Jantung Negara
• ClinicalTrials.gov Identifier: NCT06102915
• Other Study ID Numbers: IJNREC/631/2023
• First Posted: Oct 26, 2023
• Last Update Posted: Oct 26, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by SONG LIN LOW, Dr, Institut Jantung Negara: Neuromuscular Blockade; Postoperative Pulmonary Atelectasis; postoperative pulmonary complication; Coronary Artery Disease; coronary artery bypass grafting; hypothermic cardiopulmonary bypass; rocuronium; cis-atracurium
• Additional relevant MeSH terms: Pulmonary Atelectasis; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hypothermia; Bromides; Rocuronium; Atracurium; Cisatracurium

Study Results

No Results Posted as of Oct 26, 2023