Neuromuscular BlockadeNCT02376595
Pharmacokinetic and Pharmacodynamic of Rocuronium
An observational study of Neuromuscular Blockade, run by Pontificia Universidad Catolica de Chile.
Trial summary
The purpose of this study is characterize the dose-effect relationship of rocuronium bromide at the adductor pollicis and masseter muscles using an pharmacokinetic-pharmacodynamic (PKPD) model. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Rocuronium Bromide
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Jan 2015
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 10 ASA I-II patients, aged 18-65 years, scheduled for elective surgery under general anesthesia, were recruited.
Who may be able to join
- Scheduled for elective surgery under general anesthesia.
Who cannot join
- Pregnancy.
- Body mass index (BMI) >25 kg/m2.
- Anticipated difficult airway.
- Surgery associated with great volume loss.
- Presence of any neuromuscular, hepatic, renal, cardiac or respiratory disease.
- Previous history of neuromuscular blockade allergy, and/or administration of drugs known to interfere with neuromuscular blockade
About this study
Official title: Pharmacokinetic and Pharmacodynamic of Rocuronium Bromide Measured in Adductor Pollicis and Masseter Muscles.
The purpose of this study is characterize the dose-effect relationship of rocuronium bromide at the adductor pollicis and masseter muscles using an pharmacokinetic-pharmacodynamic (PKPD) model. The hypothesis is that masseter muscle has a greater sensitivity to the neuromuscular blockers (rocuronium), faster onset and slower recovery profile than the adductor pollicis muscle.
- Conditions
- Neuromuscular Blockade
- Being tested
- Rocuronium Bromide
- Keywords
- Rocuronium, Pharmacokinetics, Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium BromideDrug
Also called Rocuronium Bromide Fresenius Kabi
Rocuronium 0,3 mg/kg in less than five seconds, followed by a saline bolus.
| Study group | Role | What they receive |
|---|---|---|
| Rocuronium Bromide | Rocuronium 0,3 mg/kg administered in less than five seconds, followed by a saline bolus. Receives: Drug: Rocuronium Bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
strength measuring 2 acceleromyograph. One Placed at the masseter muscle and the other one at the adductor pollicis muscle.
Measured: 60 minutes
Measure blood concentrations after administration rocuronium
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startMar 2013
- Primary completionNov 2013
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis I Cortinez, MD, Study chair, Ponticia Universidad Católica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376595
- Sponsor's protocol ID
- 12-003
- Status last verified
- Feb 2015
- First submitted
- 12 Feb 2015
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Plaud B, Proost JH, Wierda JM, Barre J, Debaene B, Meistelman C. Pharmacokinetics and pharmacodynamics of rocuronium at the vocal cords and the adductor pollicis in humans. Clin Pharmacol Ther. 1995 Aug;58(2):185-91. doi: 10.1016/0009-9236(95)90196-5.
PubMed 7648768Donati F, Meistelman C, Plaud B. Vecuronium neuromuscular blockade at the adductor muscles of the larynx and adductor pollicis. Anesthesiology. 1991 May;74(5):833-7. doi: 10.1097/00000542-199105000-00006.
PubMed 1673592Saitoh Y, Oshima T, Nakata Y. Acceleromyographic monitoring of neuromuscular block over the orbicularis oris muscle in anesthetized patients receiving vecuronium. J Clin Anesth. 2010 Aug;22(5):318-23. doi: 10.1016/j.jclinane.2009.09.004.
PubMed 20650376Kitajima O, Suzuki T, Fukano N, Saeki S, Ogawa S, Noda Y. Onset of rocuronium-induced neuromuscular block evaluated subjectively and accerelomyographically at the masseter muscle. J Anesth. 2011 Jun;25(3):376-9. doi: 10.1007/s00540-011-1129-0. Epub 2011 Apr 12.
PubMed 21484503Cantineau JP, Porte F, d'Honneur G, Duvaldestin P. Neuromuscular effects of rocuronium on the diaphragm and adductor pollicis muscles in anesthetized patients. Anesthesiology. 1994 Sep;81(3):585-90. doi: 10.1097/00000542-199409000-00010.
PubMed 8092503Ibebunjo C, Srikant CB, Donati F. Morphological correlates of the differential responses of muscles to vecuronium. Br J Anaesth. 1999 Aug;83(2):284-91. doi: 10.1093/bja/83.2.284.
PubMed 10618945Smith CE, Donati F, Bevan DR. Differential effects of pancuronium on masseter and adductor pollicis muscles in humans. Anesthesiology. 1989 Jul;71(1):57-61. doi: 10.1097/00000542-198907000-00011.
PubMed 2751140Zhang L, Beal SL, Sheiner LB. Simultaneous vs. sequential analysis for population PK/PD data I: best-case performance. J Pharmacokinet Pharmacodyn. 2003 Dec;30(6):387-404. doi: 10.1023/b:jopa.0000012998.04442.1f.
PubMed 15000421Schnider TW, Minto CF, Gambus PL, Andresen C, Goodale DB, Shafer SL, Youngs EJ. The influence of method of administration and covariates on the pharmacokinetics of propofol in adult volunteers. Anesthesiology. 1998 May;88(5):1170-82. doi: 10.1097/00000542-199805000-00006.
PubMed 9605675Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.
PubMed 17635389Viby-Mogensen J, Ostergaard D, Donati F, Fisher D, Hunter J, Kampmann JP, Kopman A, Proost JH, Rasmussen SN, Skovgaard LT, Varin F, Wright PM. Pharmacokinetic studies of neuromuscular blocking agents: good clinical research practice (GCRP). Acta Anaesthesiol Scand. 2000 Nov;44(10):1169-90. doi: 10.1034/j.1399-6576.2000.441002.x.
PubMed 11065197Cho HE, Park MJ, Kim SC, Hong RS, Moon DC, Ahn SY. Analysis of rocuronium in human whole blood and tissues using liquid chromatography-tandem mass spectrometry. J Chromatogr Sci. 2013 Apr;51(4):297-301. doi: 10.1093/chromsci/bms252. Epub 2013 Feb 1.
PubMed 23377654Zhang L, Beal SL, Sheinerz LB. Simultaneous vs. sequential analysis for population PK/PD data II: robustness of methods. J Pharmacokinet Pharmacodyn. 2003 Dec;30(6):405-16. doi: 10.1023/b:jopa.0000012999.36063.4e.
PubMed 15000422Sheiner LB, Stanski DR, Vozeh S, Miller RD, Ham J. Simultaneous modeling of pharmacokinetics and pharmacodynamics: application to d-tubocurarine. Clin Pharmacol Ther. 1979 Mar;25(3):358-71. doi: 10.1002/cpt1979253358.
PubMed 761446Dragne A, Varin F, Plaud B, Donati F. Rocuronium pharmacokinetic-pharmacodynamic relationship under stable propofol or isoflurane anesthesia. Can J Anaesth. 2002 Apr;49(4):353-60. doi: 10.1007/BF03017322.
PubMed 11927473
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic and Pharmacodynamic of Rocuronium Bromide Measured in Adductor Pollicis and Masseter Muscles.
- ClinicalTrials.gov ID
- NCT02376595
- Acronym / sponsor ID
- 12-003
- Conditions
- Neuromuscular Blockade
- Keywords
- Rocuronium, Pharmacokinetics, Pharmacodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 3 Mar 2015 (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 characterize the dose-effect relationship of rocuronium bromide at the adductor pollicis and masseter muscles using an pharmacokinetic-pharmacodynamic (PKPD) model. The hypothesis is that masseter muscle has a greater sensitivity to the neuromuscular blockers (rocuronium), faster onset and slower recovery profile than the adductor pollicis muscle.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rocuronium Bromide | – | Drug: Rocuronium BromideRocuronium 0,3 mg/kg administered in less than five seconds, followed by a saline bolus. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 10 ASA I-II patients, aged 18-65 years, scheduled for elective surgery under general anesthesia, were recruited.
Key inclusion criteria (1 listed)
- Scheduled for elective surgery under general anesthesia.
Key exclusion criteria (6 listed)
- Pregnancy.
- Body mass index (BMI) >25 kg/m2.
- Anticipated difficult airway.
- Surgery associated with great volume loss.
- Presence of any neuromuscular, hepatic, renal, cardiac or respiratory disease.
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 BromideAlso: Rocuronium Bromide Fresenius KabiRocuronium 0,3 mg/kg in less than five seconds, followed by a saline bolus. | Drug | Rocuronium Bromide |
Primary outcome
strength measuring 2 acceleromyograph. One Placed at the masseter muscle and the other one at the adductor pollicis muscle.
Time frame: 60 minutes
Measure blood concentrations after administration rocuronium
Time frame: 120 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 3 Mar 2015.
- Background: PubMed 7648768Plaud B, Proost JH, Wierda JM, Barre J, Debaene B, Meistelman C. Pharmacokinetics and pharmacodynamics of rocuronium at the vocal cords and the adductor pollicis in humans. Clin Pharmacol Ther. 1995 Aug;58(2):185-91. doi: 10.1016/0009-9236(95)90196-5.
- Background: PubMed 1673592Donati F, Meistelman C, Plaud B. Vecuronium neuromuscular blockade at the adductor muscles of the larynx and adductor pollicis. Anesthesiology. 1991 May;74(5):833-7. doi: 10.1097/00000542-199105000-00006.
- Background: PubMed 20650376Saitoh Y, Oshima T, Nakata Y. Acceleromyographic monitoring of neuromuscular block over the orbicularis oris muscle in anesthetized patients receiving vecuronium. J Clin Anesth. 2010 Aug;22(5):318-23. doi: 10.1016/j.jclinane.2009.09.004.
- Background: PubMed 21484503Kitajima O, Suzuki T, Fukano N, Saeki S, Ogawa S, Noda Y. Onset of rocuronium-induced neuromuscular block evaluated subjectively and accerelomyographically at the masseter muscle. J Anesth. 2011 Jun;25(3):376-9. doi: 10.1007/s00540-011-1129-0. Epub 2011 Apr 12.
- Background: PubMed 8092503Cantineau JP, Porte F, d'Honneur G, Duvaldestin P. Neuromuscular effects of rocuronium on the diaphragm and adductor pollicis muscles in anesthetized patients. Anesthesiology. 1994 Sep;81(3):585-90. doi: 10.1097/00000542-199409000-00010.
- Background: PubMed 10618945Ibebunjo C, Srikant CB, Donati F. Morphological correlates of the differential responses of muscles to vecuronium. Br J Anaesth. 1999 Aug;83(2):284-91. doi: 10.1093/bja/83.2.284.
- Background: PubMed 2751140Smith CE, Donati F, Bevan DR. Differential effects of pancuronium on masseter and adductor pollicis muscles in humans. Anesthesiology. 1989 Jul;71(1):57-61. doi: 10.1097/00000542-198907000-00011.
- Background: PubMed 15000421Zhang L, Beal SL, Sheiner LB. Simultaneous vs. sequential analysis for population PK/PD data I: best-case performance. J Pharmacokinet Pharmacodyn. 2003 Dec;30(6):387-404. doi: 10.1023/b:jopa.0000012998.04442.1f.
- Background: PubMed 9605675Schnider TW, Minto CF, Gambus PL, Andresen C, Goodale DB, Shafer SL, Youngs EJ. The influence of method of administration and covariates on the pharmacokinetics of propofol in adult volunteers. Anesthesiology. 1998 May;88(5):1170-82. doi: 10.1097/00000542-199805000-00006.
- Background: PubMed 17635389Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.
- Background: PubMed 11065197Viby-Mogensen J, Ostergaard D, Donati F, Fisher D, Hunter J, Kampmann JP, Kopman A, Proost JH, Rasmussen SN, Skovgaard LT, Varin F, Wright PM. Pharmacokinetic studies of neuromuscular blocking agents: good clinical research practice (GCRP). Acta Anaesthesiol Scand. 2000 Nov;44(10):1169-90. doi: 10.1034/j.1399-6576.2000.441002.x.
- Background: PubMed 23377654Cho HE, Park MJ, Kim SC, Hong RS, Moon DC, Ahn SY. Analysis of rocuronium in human whole blood and tissues using liquid chromatography-tandem mass spectrometry. J Chromatogr Sci. 2013 Apr;51(4):297-301. doi: 10.1093/chromsci/bms252. Epub 2013 Feb 1.
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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 I Cortinez, MD study chair
Ponticia Universidad Católica
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Blockade, run by Pontificia Universidad Catolica de Chile.
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 6 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 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
strength measuring 2 acceleromyograph. One Placed at the masseter muscle and the other one at the adductor pollicis muscle. (time frame: 60 minutes). The study lists 2 primary outcomes in all. 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 NCT02376595, which also lists 19 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 3 Mar 2015.