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

NCT ID: NCT06102915

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

289 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2023-11-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Rocuronium Bromide 10 MG/ML

Intervention Type DRUG

Comparative

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

Nimbex 10 MG in 5 ML Injection

Intervention Type DRUG

Comparative

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rocuronium Bromide 10 MG/ML

Comparative

Intervention Type DRUG

Nimbex 10 MG in 5 ML Injection

Comparative

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Esmeron Cis-atracurium

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institut Jantung Negara

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

SONG LIN LOW

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

SONG LIN LOW, MBBS

Role: PRINCIPAL_INVESTIGATOR

IJN

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institut Jantung Negara

Kuala Lumpur, , Malaysia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Malaysia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 12638566 (View on PubMed)

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.

Reference Type RESULT
PMID: 18603747 (View on PubMed)

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.

Reference Type RESULT
PMID: 12456412 (View on PubMed)

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.

Reference Type RESULT
PMID: 9821999 (View on PubMed)

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

Reference Type RESULT
PMID: 28186222 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IJNREC/631/2023

Identifier Type: -

Identifier Source: org_study_id