Neuromuscular BlockadeNCT06102915
Rocuronium vs Cis-atracurium: Do Rocuronium Still 'ROCKS' In Coronary Artery Bypass Grafting
An observational study of Neuromuscular Blockade and Postoperative Pulmonary Atelectasis, run by Institut Jantung Negara at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blockade, Postoperative Pulmonary Atelectasis, Postoperative Pulmonary Complication
- What is being tested?
- Rocuronium Bromide 10 MG/ML and Nimbex 10 MG in 5 ML Injection
- Type of treatment
- Injection or infusion
- How many people
- 289 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Aug 2023to 23 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients that undergo general anaesthesia for CABG surgery requiring neuromuscular blockade of either rocuronium or cis-atracurium
Who may be able to join
- All patients that undergo general anaesthesia for CABG surgery requiring neuromuscular blockade of either rocuronium or cis-atracurium
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Rocuronium Bromide 10 MG/ML, Nimbex 10 MG in 5 ML Injection
- Keywords
- Neuromuscular Blockade, Postoperative Pulmonary Atelectasis, postoperative pulmonary complication, Coronary Artery Disease, coronary artery bypass grafting, hypothermic cardiopulmonary bypass, rocuronium, cis-atracurium
- Medical subject headings
- Pulmonary Atelectasis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium Bromide 10 MG/MLDrug
Also called Esmeron
Comparative
Nimbex 10 MG in 5 ML InjectionDrug
Also called Cis-atracurium
Comparative
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Nimbex 10 MG in 5 ML Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative pulmonary complication
Which neuromuscular relaxant is associated with lesser postoperative pulmonary complication
Measured: 6 months
Secondary outcomes (3)
Ventilation hours in ICU
Ventilation hours from ICU admission from OR to extubation
Measured: 6 months
Requirements for Non-invasive ventilation
NIV duration
Measured: 6 months
Incidence of postoperative atrial fibrillation
Incidence of postoperative atrial fibrillation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Aug 2023
- Primary completion23 Nov 2023
- Study completion23 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Jantung Negara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SONG LIN LOW, Institut Jantung Negara
- Investigators
- SONG LIN LOW, MBBS, Principal investigator, IJN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102915
- Sponsor's protocol ID
- IJNREC/631/2023
- Status last verified
- Nov 2023
- First submitted
- 22 Oct 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 12638566Hemmerling 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.
PubMed 18603747Murphy 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.
PubMed 12456412Naguib 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.
PubMed 9821999Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.
PubMed 28186222
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rocuronium vs Cis-atracurium: Do Rocuronium Still 'ROCKS' In Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT06102915
- Acronym / sponsor ID
- IJNREC/631/2023
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Institut Jantung NegaraUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- 23 Nov 2023 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rocuronium | – | Drug: Rocuronium Bromide 10 MG/MLRocuronium 1mg/kg to be given at induction of anaesthesia and another 1mg/kg would be given when the patient is on hypothermic cardiopulmonary bypass |
| Cis-atracurium | – | Drug: Nimbex 10 MG in 5 ML InjectionCis-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that undergo general anaesthesia for CABG surgery requiring neuromuscular blockade of either rocuronium or cis-atracurium
Key inclusion criteria (1 listed)
- All patients that undergo general anaesthesia for CABG surgery requiring neuromuscular blockade of either rocuronium or cis-atracurium
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocuronium Bromide 10 MG/MLAlso: EsmeronComparative | Drug | Rocuronium |
| Nimbex 10 MG in 5 ML InjectionAlso: Cis-atracuriumComparative | Drug | Cis-atracurium |
Primary outcome
Incidence of postoperative pulmonary complication
Time frame: 6 months
Which neuromuscular relaxant is associated with lesser postoperative pulmonary complication
3 secondary outcomes
Ventilation hours in ICU
Time frame: 6 months
Requirements for Non-invasive ventilation
Time frame: 6 months
Incidence of postoperative atrial fibrillation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Results publication: PubMed 12638566Thomas 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.
- Results publication: PubMed 18603747Hemmerling 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.
- Results publication: PubMed 12456412Murphy 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.
- Results publication: PubMed 9821999Naguib 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.
- Results publication: PubMed 28186222Miskovic A, Lumb AB. Postoperative pulmonary complications. Br J Anaesth. 2017 Mar 1;118(3):317-334. doi: 10.1093/bja/aex002.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SONG LIN LOW, MBBS principal investigator
IJN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Blockade and Postoperative Pulmonary Atelectasis, run by Institut Jantung Negara at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative pulmonary complication (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06102915, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.