Postoperative Residual CurarizationPhase 4NCT01651572
Comparison Between Cisatracurium and Rocuronium in Terms of Recovery of the Muscular Strength in the Postoperative Phase After Surgery and General Anaesthesia
A Phase 4 study testing Cisatracurium and Rocuronium in people with Postoperative Residual Curarization and Residual Neuromuscular Block, run by Azienda Ospedaliera di Padova at 1 site in Italy.
Trial summary
The purpose of this study is to determine the incidence of post-operative residual curarization in our patients and to determine if Cisatracurium and Rocuronium behave differently from each other in terms of residual curarization. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Residual Curarization, Residual Neuromuscular Block
- What is being tested?
- Cisatracurium and Rocuronium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2012to Jul 2013
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- general anaesthesia with need to use of neuromuscular-blocking agents
- awakening and extubation of the patient in the operating room and permanence in the PACU for at least 60 minutes
- age 18-80
- surgical operations lasting at least 1 hour
- ASA class I-III
- possibility to apply TOF-monitoring with thumb-acceleromyography
- women of childbearing age not using contraceptives
- women of childbearing age using contraceptives
Who cannot join
- subjects unable to give a valid consent
- patients in emergency situations
- patients not awakened and not extubated in the operating room
- age above 80 years or under 18 years
- surgical operations lasting less than an hour
- ASA class IV
Show all 12Show fewer
- impossibility to apply and/or perform TOF-monitoring
- neuromuscular diseases
- intake of therapies interfering with the neuromuscular function
- patients having contraindications for either studied drug
- pregnant women
- women who are breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Post-operative Residual Curarization (PORC) Incidence in Patients Undergoing Surgery With General Anaesthesia; Comparison Between Cisatracurium and Rocuronium. A Randomised, Single-blind Phase 4 Study.
The purpose of this study is to determine the incidence of post-operative residual curarization in our patients and to determine if Cisatracurium and Rocuronium behave differently from each other in terms of residual curarization.
- Being tested
- Cisatracurium, Rocuronium
- Keywords
- Postoperative residual curarization, Residual neuromuscular block, Complications, Postoperative, Neuromuscular function, Neuromuscular block
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisatracuriumDrug
Cisatracurium (Nimbex):
- initial dose: 0.2 mg/kg
- maintaining dose: 0.1 mg/kg (repeated anytime TOF-count reaches 2 twitches)
RocuroniumDrug
Rocuronium (Esmeron):
- initial dose: 0.6 mg/kg
- maintaining dose: 0.15 mg/kg (repeated anytime TOF-count reaches 2 twitches)
| Study group | Role | What they receive |
|---|---|---|
| Cisatracurium | Experimental | Induction and maintaining of anaesthesia with Propofol. Analgesia either with Fentanyl or Fentanyl+Remifentanyl.
Cisatracurium (Nimbex):
* initial dose: 0.2 mg/kg
* maintaining dose: 0.1 mg/kg (repeated anytime TOF-count reaches 2 twitches)
At the end of the surgical operation, patients will be administered Neostigmine 0.04 mg/kg and Atropine 0.02 mg/kg.
Patients will be extubated with a TOF-Ratio of at least 0.90. Receives: Drug: Cisatracurium |
| Rocuronium | Experimental | Induction and maintaining of anaesthesia with Propofol. Analgesia either with Fentanyl or Fentanyl+Remifentanyl
Rocuronium (Esmeron):
* initial dose: 0.6 mg/kg
* maintaining dose: 0.15 mg/kg (repeated anytime TOF-count reaches 2 twitches)
At the end of the surgical operation, patients will be administered Neostigmine 0.04 mg/kg and Atropine 0.02 mg/kg.
Patients will be extubated with a TOF-Ratio of at least 0.90. Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PORC
To determine the incidence of post-operative residual curarization in our operating rooms, comparing two different neuromuscular-blocking agents: Cisatracurium and Rocuronium.
The primary endpoint is quantified with TOF-Ratio, determined with the device TOF-Watch SX (Organon, Netherlands). A TOF-Ratio<0.90 defines PORC.
Three clinical parameters (head-tilt for 5 seconds, ability to swallow, presence of diplopia) are also evaluated.
TOF-Ratios, as long as the above-mentioned clinical parameters are determined and evaluated at 15, 30 and 60 minutes after extubation of the patient.
Measured: Participants will be followed for the duration of their stay in the post-anaesthesia care unit (PACU), an expected average of 60 minutes.
Secondary outcomes (1)
Incidence of PORC - comparison between Cisatracurium and Rocuronium
Measured: Participants will be followed for the duration of their stay in the post-anaesthesia care unit (PACU), an expected average of 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Residual CurarizationStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Paolo Feltracco, Azienda Ospedaliera di Padova
- Investigators
- Carlo Ori, Prof. M.D., Study chair, Università degli Studi di Padova - Azienda Ospedaliera di PadovaPaolo Feltracco, M.D., Principal investigator, Azienda Ospedaliera di Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651572
- Sponsor's protocol ID
- 2633Pbis
- Other IDs
- 2012-002398-68, CURARI_2012
- Status last verified
- Mar 2014
- First submitted
- 23 Jul 2012
- Last updated
- 11 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Post-operative Residual Curarization (PORC) Incidence in Patients Undergoing Surgery With General Anaesthesia; Comparison Between Cisatracurium and Rocuronium. A Randomised, Single-blind Phase 4 Study.
- ClinicalTrials.gov ID
- NCT01651572
- Acronym / sponsor ID
- 2633Pbis
- Keywords
- Postoperative residual curarization, Residual neuromuscular block, Complications, Postoperative, Neuromuscular function, Neuromuscular block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Azienda Ospedaliera di PadovaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 Jul 2012 (estimated)
- 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 purpose of this study is to determine the incidence of post-operative residual curarization in our patients and to determine if Cisatracurium and Rocuronium behave differently from each other in terms of residual curarization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cisatracurium | Experimental | Drug: CisatracuriumInduction and maintaining of anaesthesia with Propofol. Analgesia either with Fentanyl or Fentanyl+Remifentanyl. Cisatracurium (Nimbex): * initial dose: 0.2 mg/kg * maintaining dose: 0.1 mg/kg (repeated anytime TOF-count reaches 2 twitches) At the end of the surgical operation, patients will be administered Neostigmine 0.04 mg/kg and Atropine 0.02 mg/kg. Patients will be extubated with a TOF-Ratio of at least 0.90. |
| Rocuronium | Experimental | Drug: RocuroniumInduction and maintaining of anaesthesia with Propofol. Analgesia either with Fentanyl or Fentanyl+Remifentanyl Rocuronium (Esmeron): * initial dose: 0.6 mg/kg * maintaining dose: 0.15 mg/kg (repeated anytime TOF-count reaches 2 twitches) At the end of the surgical operation, patients will be administered Neostigmine 0.04 mg/kg and Atropine 0.02 mg/kg. Patients will be extubated with a TOF-Ratio of at least 0.90. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- general anaesthesia with need to use of neuromuscular-blocking agents
- awakening and extubation of the patient in the operating room and permanence in the PACU for at least 60 minutes
- age 18-80
- surgical operations lasting at least 1 hour
- ASA class I-III
Key exclusion criteria (12 listed)
- subjects unable to give a valid consent
- patients in emergency situations
- patients not awakened and not extubated in the operating room
- age above 80 years or under 18 years
- surgical operations lasting less than an hour
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 |
|---|---|---|
| CisatracuriumCisatracurium (Nimbex): * initial dose: 0.2 mg/kg * maintaining dose: 0.1 mg/kg (repeated anytime TOF-count reaches 2 twitches) | Drug | Cisatracurium |
| RocuroniumRocuronium (Esmeron): * initial dose: 0.6 mg/kg * maintaining dose: 0.15 mg/kg (repeated anytime TOF-count reaches 2 twitches) | Drug | Rocuronium |
Primary outcome
Incidence of PORC
Time frame: Participants will be followed for the duration of their stay in the post-anaesthesia care unit (PACU), an expected average of 60 minutes.
To determine the incidence of post-operative residual curarization in our operating rooms, comparing two different neuromuscular-blocking agents: Cisatracurium and Rocuronium. The primary endpoint is quantified with TOF-Ratio, determined with the device TOF-Watch SX (Organon, Netherlands). A TOF-Ratio<0.90 defines PORC. Three clinical parameters (head-tilt for 5 seconds, ability to swallow, presence of diplopia) are also evaluated. TOF-Ratios, as long as the above-mentioned clinical parameters are determined and evaluated at 15, 30 and 60 minutes after extubation of the patient.
1 secondary outcome
Incidence of PORC - comparison between Cisatracurium and Rocuronium
Time frame: Participants will be followed for the duration of their stay in the post-anaesthesia care unit (PACU), an expected average of 60 minutes.
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 11 Mar 2014.
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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.
Carlo Ori, Prof. M.D. study chair
Università degli Studi di Padova - Azienda Ospedaliera di Padova
Paolo Feltracco, M.D. principal investigator
Azienda Ospedaliera di Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cisatracurium and Rocuronium in people with Postoperative Residual Curarization and Residual Neuromuscular Block, run by Azienda Ospedaliera di Padova at 1 site in Italy.
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 8 inclusion and 12 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 11 Mar 2014. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 PORC (time frame: Participants will be followed for the duration of their stay in the post-anaesthesia care unit (PACU), an expected average of 60 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2014.