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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06102915
• Other study ID #: IJNREC/631/2023
• Status: Completed
• Start date: August 1, 2023
• Est. completion date: November 23, 2023

Study information

• Verified date: November 2023
• Source: Institut Jantung Negara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: November 23, 2023
• Est. primary completion date: November 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting
• Coronary Artery Disease
• Coronary Disease
• Hypothermia
• Myocardial Ischemia
• Neuromuscular Blockade
• Postoperative Pulmonary Atelectasis
• Postoperative Pulmonary Complication
• Pulmonary Atelectasis

Intervention

Drug:
• Rocuronium Bromide 10 MG/ML
Comparative
• Nimbex 10 MG in 5 ML Injection
Comparative

Locations

Country	Name	City	State
Malaysia	Institut Jantung Negara	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Institut Jantung Negara

Country where clinical trial is conducted

Malaysia, 

References & Publications (5)

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. — View Citation

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

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. — View Citation

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. Erratum In: Ane — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative pulmonary complication	Which neuromuscular relaxant is associated with lesser postoperative pulmonary complication	6 months
Secondary	Ventilation hours in ICU	Ventilation hours from ICU admission from OR to extubation	6 months
Secondary	Requirements for Non-invasive ventilation	NIV duration	6 months
Secondary	Incidence of postoperative atrial fibrillation	Incidence of postoperative atrial fibrillation	6 months