PainPhase 4NCT02048293
Pharmacodynamic Differences Between Branded and Unbranded Remifentanil Molecules
A Phase 4 study testing Remifentanyl, Ultiva®, Remifentanil Laboratorios Chalver de Colombia S.A. and Fada Remifentanilo in people with Pain, run by Fundación Universitaria de Ciencias de la Salud at 1 site in Colombia.
Trial summary
Unbranded drug molecules are produced after the patent of a given drug has expired. Unbranded molecules of Remifentanil have been marketed in Colombia, and several reports by anesthesiologist indicate that there are differences in the physiologic response of patients to these molecules. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Pain
- What is being tested?
- Remifentanyl, Ultiva®, Remifentanil Laboratorios Chalver de Colombia S.A. and Fada Remifentanilo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteColombia
- Study dates
- Oct 2012to Dec 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients requiring orotracheal intubation
- 18-50 years old
- Body mass index <31 kg/m2
- Written informed consent
Who cannot join
- Pregnancy
- Risk of difficult airway
- History of opioid use
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Fundación Universitaria de Ciencias de la Salud, Hospital de San Jose
Bogota, Cundinamarca, 11001000
About this study
Official title: Pharmacodynamic Differences Between Branded and Unbranded Remifentanil Molecules Available in Colombia for Tracheal Intubation of Adult Patients, 2012-2013
Unbranded drug molecules are produced after the patent of a given drug has expired. Unbranded molecules of Remifentanil have been marketed in Colombia, and several reports by anesthesiologist indicate that there are differences in the physiologic response of patients to these molecules. The investigators hypothesized that unbranded molecules of remifentanil require higher doses to obtain desired physiological responses as compared to the branded molecule.
Read the detailed description
Introduction. Several remifentanil products are commercialized in Colombia while these have never been compared in a clinical setting.
Objective. The aim of this study was to investigate the pharmacodynamic profile of the innovative molecule of remifentanil (group O = Ultiva®) and two unbranded molecules (group A = Remifentanil Laboratorios Chalver de Colombia S.A. and group B = Fada Remifentanilo) registered in Colombia.
Methods. The investigators carried out a double-blind, randomized, controlled trial. The branded molecule of remifentanil (group O, n=29) was compared against the two unbranded molecules (group A, n=29; group B, n=32) during anesthetic induction and tracheal intubation in adult patients American Society of Anesthesiology Physical Status Classification = I without predictors for difficult airway. The target controlled infusion (TCI) doses evaluated were 6, 8 and 10 ng/ml with the Minto model. Induction was complemented with propofol 5 mg/ml (TCI) with the Schneider model and rocuronium 0.6 mg/kg. The primary outcome was defined as the difference in mean arterial pressure and heart rate pre-intubation (TCI equilibrium) and post-intubation (maximum measurement within 5 minutes).
- Conditions
- Pain
- Being tested
- Remifentanyl, Ultiva®, Remifentanil Laboratorios Chalver de Colombia S.A., Fada Remifentanilo
- Keywords
- remifentanil, propofol, pharmacodynamic, total intravenous anesthesia, orotracheal intubation, heart rate, mean arterial pressure, Cooper intubation condition score
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanyl, Ultiva®Drug
Anesthetic induction for orotracheal intubation. Group O
Remifentanil Laboratorios Chalver de Colombia S.A.Drug
Anesthetic induction for orotracheal intubation. Group A
Fada RemifentaniloDrug
Anesthetic induction for orotracheal intubation. Group B
| Study group | Role | What they receive |
|---|---|---|
| Group O | Active comparator | Remifentanyl innovative molecule = Ultiva® Receives: Drug: Remifentanyl, Ultiva®; Drug: Fada Remifentanilo |
| Group A | Active comparator | Remifentanyl comparator A = Remifentanil Laboratorios Chalver de Colombia S.A. Receives: Drug: Remifentanil Laboratorios Chalver de Colombia S.A.; Drug: Fada Remifentanilo |
| Group B | Active comparator | Remifentanyl comparator B = Fada Remifentanilo Receives: Drug: Remifentanyl, Ultiva®; Drug: Remifentanil Laboratorios Chalver de Colombia S.A. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome of heart rate or mean arterial pressure difference before and after tracheal intubation
Heart rate measured with EKG. Mean arterial pressure measured with automatic blood pressure cuff.
Measured: Average of 5 minutes
Secondary outcomes (1)
Cooper intubation condition score
Jaw relaxation: 0 poor, 1 minimum, 2 moderate, 3 good. Vocal cords: 0 closed, 1 closing, 2 moving, 3 open. Intubation response: 0 severe cough, 1 mild cough, 2 mild diaphragmatic movement, 3 no response.
Cooper score: Jaw relaxation + Vocal cords + Intubation response
Measured: Measured during tracheal intubation, average of 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startOct 2012
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Universitaria de Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de San Jose
- Responsible party
- Principal investigator, Luis Eduardo Reyes Ortiz, MD, Fundación Universitaria de Ciencias de la Salud
- Investigators
- luis e reyes, professor, Principal investigator, fundacion universitaria de ciencias de la salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048293
- Sponsor's protocol ID
- 326-3847-22
- Status last verified
- Jan 2014
- First submitted
- 23 Jan 2014
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kwak HJ, Min SK, Kim DH, Kang M, Kim JY. Effect-site concentration of remifentanil for nasotracheal versus orotracheal intubation during target-controlled infusion of propofol. J Int Med Res. 2011;39(5):1816-23. doi: 10.1177/147323001103900524.
PubMed 22117982Lysakowski C, Dumont L, Pellegrini M, Clergue F, Tassonyi E. Effects of fentanyl, alfentanil, remifentanil and sufentanil on loss of consciousness and bispectral index during propofol induction of anaesthesia. Br J Anaesth. 2001 Apr;86(4):523-7. doi: 10.1093/bja/86.4.523.
PubMed 11573626Coskun D, Celebi H, Karaca G, Karabiyik L. Remifentanil versus fentanyl compared in a target-controlled infusion of propofol anesthesia: quality of anesthesia and recovery profile. J Anesth. 2010 Jun;24(3):373-9. doi: 10.1007/s00540-010-0898-1. Epub 2010 Mar 13.
PubMed 20229001
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Differences Between Branded and Unbranded Remifentanil Molecules Available in Colombia for Tracheal Intubation of Adult Patients, 2012-2013
- ClinicalTrials.gov ID
- NCT02048293
- Acronym / sponsor ID
- 326-3847-22
- Conditions
- Pain
- Keywords
- remifentanil, propofol, pharmacodynamic, total intravenous anesthesia, orotracheal intubation, heart rate, mean arterial pressure, Cooper intubation condition score
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Fundación Universitaria de Ciencias de la SaludUniversity, hospital or other
- Collaborators
- Hospital de San Jose
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Jan 2014 (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.
Unbranded drug molecules are produced after the patent of a given drug has expired. Unbranded molecules of Remifentanil have been marketed in Colombia, and several reports by anesthesiologist indicate that there are differences in the physiologic response of patients to these molecules. The investigators hypothesized that unbranded molecules of remifentanil require higher doses to obtain desired physiological responses as compared to the branded molecule.
Detailed description
Introduction. Several remifentanil products are commercialized in Colombia while these have never been compared in a clinical setting.
Objective. The aim of this study was to investigate the pharmacodynamic profile of the innovative molecule of remifentanil (group O = Ultiva®) and two unbranded molecules (group A = Remifentanil Laboratorios Chalver de Colombia S.A. and group B = Fada Remifentanilo) registered in Colombia.
Methods. The investigators carried out a double-blind, randomized, controlled trial. The branded molecule of remifentanil (group O, n=29) was compared against the two unbranded molecules (group A, n=29; group B, n=32) during anesthetic induction and tracheal intubation in adult patients American Society of Anesthesiology Physical Status Classification = I without predictors for difficult airway. The target controlled infusion (TCI) doses evaluated were 6, 8 and 10 ng/ml with the Minto model. Induction was complemented with propofol 5 mg/ml (TCI) with the Schneider model and rocuronium 0.6 mg/kg. The primary outcome was defined as the difference in mean arterial pressure and heart rate pre-intubation (TCI equilibrium) and post-intubation (maximum measurement within 5 minutes).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group O | Active comparator | Drug: Remifentanyl, Ultiva®, Drug: Fada RemifentaniloRemifentanyl innovative molecule = Ultiva® |
| Group A | Active comparator | Drug: Remifentanil Laboratorios Chalver de Colombia S.A., Drug: Fada RemifentaniloRemifentanyl comparator A = Remifentanil Laboratorios Chalver de Colombia S.A. |
| Group B | Active comparator | Drug: Remifentanyl, Ultiva®, Drug: Remifentanil Laboratorios Chalver de Colombia S.A.Remifentanyl comparator B = Fada Remifentanilo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients requiring orotracheal intubation
- 18-50 years old
- Body mass index <31 kg/m2
- Written informed consent
Key exclusion criteria (3 listed)
- Pregnancy
- Risk of difficult airway
- History of opioid use
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 |
|---|---|---|
| Remifentanyl, Ultiva®Anesthetic induction for orotracheal intubation. Group O | Drug | Group B, Group O |
| Remifentanil Laboratorios Chalver de Colombia S.A.Anesthetic induction for orotracheal intubation. Group A | Drug | Group A, Group B |
| Fada RemifentaniloAnesthetic induction for orotracheal intubation. Group B | Drug | Group A, Group O |
Primary outcome
Composite outcome of heart rate or mean arterial pressure difference before and after tracheal intubation
Time frame: Average of 5 minutes
Heart rate measured with EKG. Mean arterial pressure measured with automatic blood pressure cuff.
1 secondary outcome
Cooper intubation condition score
Time frame: Measured during tracheal intubation, average of 30 seconds
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 29 Jan 2014.
- Background: PubMed 22117982Kwak HJ, Min SK, Kim DH, Kang M, Kim JY. Effect-site concentration of remifentanil for nasotracheal versus orotracheal intubation during target-controlled infusion of propofol. J Int Med Res. 2011;39(5):1816-23. doi: 10.1177/147323001103900524.
- Background: PubMed 11573626Lysakowski C, Dumont L, Pellegrini M, Clergue F, Tassonyi E. Effects of fentanyl, alfentanil, remifentanil and sufentanil on loss of consciousness and bispectral index during propofol induction of anaesthesia. Br J Anaesth. 2001 Apr;86(4):523-7. doi: 10.1093/bja/86.4.523.
- Background: PubMed 20229001Coskun D, Celebi H, Karaca G, Karabiyik L. Remifentanil versus fentanyl compared in a target-controlled infusion of propofol anesthesia: quality of anesthesia and recovery profile. J Anesth. 2010 Jun;24(3):373-9. doi: 10.1007/s00540-010-0898-1. Epub 2010 Mar 13.
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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.
luis e reyes, professor principal investigator
fundacion universitaria de ciencias de la salud
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 Remifentanyl, Ultiva®, Remifentanil Laboratorios Chalver de Colombia S.A. and Fada Remifentanilo in people with Pain, run by Fundación Universitaria de Ciencias de la Salud at 1 site in Colombia.
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 4 inclusion and 3 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 29 Jan 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 Colombia. 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?
Composite outcome of heart rate or mean arterial pressure difference before and after tracheal intubation (time frame: Average of 5 minutes). 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 NCT02048293, which also lists 3 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 29 Jan 2014.