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

NCT06102915 | Completed

• 1 other identifier: IJNREC/631/2023
• Study Type: observational
• Target: 289
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative pulmonary complication

  Which neuromuscular relaxant is associated with lesser postoperative pulmonary complication

  6 months

Secondary Outcomes (3)

• Ventilation hours in ICU

  6 months

• Requirements for Non-invasive ventilation

  6 months

• Incidence of postoperative atrial fibrillation

  6 months

Study Arms (2)

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

Rocuronium Bromide 10 MG/ML DRUG

Comparative

Also known as: Esmeron

Rocuronium

Nimbex 10 MG in 5 ML Injection DRUG

Comparative

Also known as: Cis-atracurium

Cis-atracurium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Jantung Negara: lead

Study Sites (1)

Institut Jantung Negara

Kuala Lumpur, 50400, Malaysia

Location

Related Publications (5)

• 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.

  PMID: 12638566 RESULT

• Hemmerling TM, Russo G, Bracco D. Neuromuscular blockade in cardiac surgery: an update for clinicians. Ann Card Anaesth. 2008 Jul-Dec;11(2):80-90. doi: 10.4103/0971-9784.41575.

  PMID: 18603747 RESULT

• Murphy GS, Szokol JW, Vender JS, Marymont JH, Avram MJ. The use of neuromuscular blocking drugs in adult cardiac surgery: results of a national postal survey. Anesth Analg. 2002 Dec;95(6):1534-9, table of contents. doi: 10.1097/00000539-200212000-00012.

  PMID: 12456412 RESULT

• Naguib M, Samarkandi AH, Ammar A, Elfaqih SR, Al-Zahrani S, Turkistani A. Comparative clinical pharmacology of rocuronium, cisatracurium, and their combination. Anesthesiology. 1998 Nov;89(5):1116-24. doi: 10.1097/00000542-199811000-00011.

  PMID: 9821999 RESULT

• Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.

  PMID: 28186222 RESULT

MeSH Terms

Conditions

Pulmonary Atelectasis; Coronary Artery Disease

Interventions

Rocuronium; cisatracurium; Injections

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• SONG LIN LOW, MBBS

  IJN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 26, 2023
• Study Start: August 1, 2023
• Primary Completion: November 23, 2023
• Study Completion: November 23, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

MY (1)