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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06102915
Other study ID # IJNREC/631/2023
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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