Neuromuscular BlockadePhase 4NCT01101139
Sugammadex Improves Muscle Function After Standard Neuromuscular Recovery
A Phase 4 study testing Sugammadex in people with Neuromuscular Blockade, run by Technical University of Munich at 1 site in Germany.
Trial summary
This study is designed to investigate, whether Sugammadex improves muscle function after standard neuromuscular recovery (TOF 0.9) from relaxation with rocuronium. 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?
- Sugammadex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Jun 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical stauts II - III
- Age: 18 - 65 years
- Patients scheduled for general anesthesia with intubation using rocuronium
- Patients have given informed consent to the study
- Patients receiving the investigational drug within 15 minutes after neuromuscular recovery to a TOF 0.9
- Sufficient knowledge of the German language
Who cannot join
- known or suspected neuromuscular disease
- significant hepatic or renal dysfunction
- known or suspected history or family history of disposition to malignant hyperthermia
- known or suspected allergy towards sugammadex, anesthetics, muscle relaxants, or other drugs used for general anesthesia
- Use o drugs that interfere with sugammadex
- Patients included in another trial within the last 30 days
Show all 10Show fewer
- Patients with legal guidant
- Patients with contradiction towards the use of Sugammadex
- Pregnant women
- Breast-feeding women
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Anaesthesiologie Klinikum München rechts der Isar
Munich, Bavaria, 81675
About this study
Official title: Small Dose of Sugammadex Improves Muscle Function After Standard Neuromuscular Recovery (TOF 0.9)
This study is designed to investigate, whether Sugammadex improves muscle function after standard neuromuscular recovery (TOF 0.9) from relaxation with rocuronium.
Read the detailed description
Muscle relaxants are an integral part of today's anesthesia. They improve intubating conditions and reduce doses of other substances needed for general anesthesia. For ensuring patient safety, neuromuscular function is monitored during general anesthesia. The latter one is only terminated, when neuromuscular monitoring shows an objective normal value. Despite this accurate surveillance, a lot of patients complain about subjectively uncomfortable muscle weakness in the recovery room. A possible explanation for this ostensive contradiction can be the variable "margin of safety" of neuromuscluar transmission in different muscle groups. Waud et al describe this phenomenon, as the fact, that neuromuscular transmission is only clinically detectable, when a certain number of post-synaptic receptors is not blocked. The necessary fraction of free receptors differs a lot between the muscle groups (15-50%). As neuromuscular monitoring only measures one muscle group exemplarily, and a clinically non-detectable number of post-synaptic receptors can be blocked shortly after anesthesia, the subjective muscle weakness of patients could need treatment.
Sugammadex can encapsulate steroid-typ muscle relaxants within 2 to 5 minutes. After applying a sufficiently high dose, also those receptors will be free that elude neuromuscular monitoring. This constellation brings up the interesting problem to quantify the possible effect on patients' subjective muscle weakness.
This study is designed to investigate, if the application of sugammadex improves muscle function and consequently well-being of patients, that have been extubated according to clinical standard.
- Conditions
- Neuromuscular Blockade
- Being tested
- Sugammadex, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Sugammadex (single intravenous injection 0.25 mg/kg)
PlaceboDrug
Placebo: single intravenous injection Saline 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Single injection of Sugammadex 0.25 mg/kg Receives: Drug: Sugammadex |
| Placebo comparator | Placebo comparator | Single injection of Saline 0.9% Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle function
Muscle function following the investigational drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2011
- Study completionJun 2011
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.
- More trials run by Technical University of MunichThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manfred Blobner, M.D., Principal investigator, Klinik für Anaesthesiologie Klinikum München rechts der Isar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101139
- Sponsor's protocol ID
- SIMAR
- Status last verified
- Dec 2012
- First submitted
- 8 Apr 2010
- Last updated
- 17 Dec 2012
- Results posted
- No
Publications
Berg H, Roed J, Viby-Mogensen J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Residual neuromuscular block is a risk factor for postoperative pulmonary complications. A prospective, randomised, and blinded study of postoperative pulmonary complications after atracurium, vecuronium and pancuronium. Acta Anaesthesiol Scand. 1997 Oct;41(9):1095-1103. doi: 10.1111/j.1399-6576.1997.tb04851.x.
PubMed 9366929Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.
PubMed 18635478Puhringer FK, Rex C, Sielenkamper AW, Claudius C, Larsen PB, Prins ME, Eikermann M, Khuenl-Brady KS. Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial. Anesthesiology. 2008 Aug;109(2):188-97. doi: 10.1097/ALN.0b013e31817f5bc7.
PubMed 18648227Waud DR, Waud BE. In vitro measurement of margin of safety of neuromuscular transmission. Am J Physiol. 1975 Dec;229(6):1632-4. doi: 10.1152/ajplegacy.1975.229.6.1632.
PubMed 1211496Baumuller E, Schaller SJ, Chiquito Lama Y, Frick CG, Bauhofer T, Eikermann M, Fink H, Blobner M. Postoperative impairment of motor function at train-of-four ratio >/=0.9 cannot be improved by sugammadex (1 mg kg-1). Br J Anaesth. 2015 May;114(5):785-93. doi: 10.1093/bja/aeu453. Epub 2015 Jan 13.
PubMed 25586724
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Dose of Sugammadex Improves Muscle Function After Standard Neuromuscular Recovery (TOF 0.9)
- ClinicalTrials.gov ID
- NCT01101139
- Acronym / sponsor ID
- SIMAR
- Conditions
- Neuromuscular Blockade
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 9 Apr 2010 (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.
This study is designed to investigate, whether Sugammadex improves muscle function after standard neuromuscular recovery (TOF 0.9) from relaxation with rocuronium.
Detailed description
Muscle relaxants are an integral part of today's anesthesia. They improve intubating conditions and reduce doses of other substances needed for general anesthesia. For ensuring patient safety, neuromuscular function is monitored during general anesthesia. The latter one is only terminated, when neuromuscular monitoring shows an objective normal value. Despite this accurate surveillance, a lot of patients complain about subjectively uncomfortable muscle weakness in the recovery room. A possible explanation for this ostensive contradiction can be the variable "margin of safety" of neuromuscluar transmission in different muscle groups. Waud et al describe this phenomenon, as the fact, that neuromuscular transmission is only clinically detectable, when a certain number of post-synaptic receptors is not blocked. The necessary fraction of free receptors differs a lot between the muscle groups (15-50%). As neuromuscular monitoring only measures one muscle group exemplarily, and a clinically non-detectable number of post-synaptic receptors can be blocked shortly after anesthesia, the subjective muscle weakness of patients could need treatment.
Sugammadex can encapsulate steroid-typ muscle relaxants within 2 to 5 minutes. After applying a sufficiently high dose, also those receptors will be free that elude neuromuscular monitoring. This constellation brings up the interesting problem to quantify the possible effect on patients' subjective muscle weakness.
This study is designed to investigate, if the application of sugammadex improves muscle function and consequently well-being of patients, that have been extubated according to clinical standard.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: SugammadexSingle injection of Sugammadex 0.25 mg/kg |
| Placebo comparator | Placebo comparator | Drug: PlaceboSingle injection of Saline 0.9% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ASA physical stauts II - III
- Age: 18 - 65 years
- Patients scheduled for general anesthesia with intubation using rocuronium
- Patients have given informed consent to the study
- Patients receiving the investigational drug within 15 minutes after neuromuscular recovery to a TOF 0.9
Key exclusion criteria (10 listed)
- known or suspected neuromuscular disease
- significant hepatic or renal dysfunction
- known or suspected history or family history of disposition to malignant hyperthermia
- known or suspected allergy towards sugammadex, anesthetics, muscle relaxants, or other drugs used for general anesthesia
- Use o drugs that interfere with sugammadex
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 |
|---|---|---|
| SugammadexSugammadex (single intravenous injection 0.25 mg/kg) | Drug | Experimental |
| PlaceboPlacebo: single intravenous injection Saline 0.9% | Drug | Placebo comparator |
Primary outcome
Muscle function
Muscle function following the investigational drug
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 17 Dec 2012.
- Background: PubMed 9366929Berg H, Roed J, Viby-Mogensen J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Residual neuromuscular block is a risk factor for postoperative pulmonary complications. A prospective, randomised, and blinded study of postoperative pulmonary complications after atracurium, vecuronium and pancuronium. Acta Anaesthesiol Scand. 1997 Oct;41(9):1095-1103. doi: 10.1111/j.1399-6576.1997.tb04851.x.
- Background: PubMed 18635478Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.
- Background: PubMed 18648227Puhringer FK, Rex C, Sielenkamper AW, Claudius C, Larsen PB, Prins ME, Eikermann M, Khuenl-Brady KS. Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial. Anesthesiology. 2008 Aug;109(2):188-97. doi: 10.1097/ALN.0b013e31817f5bc7.
- Background: PubMed 1211496Waud DR, Waud BE. In vitro measurement of margin of safety of neuromuscular transmission. Am J Physiol. 1975 Dec;229(6):1632-4. doi: 10.1152/ajplegacy.1975.229.6.1632.
- Derived from this study: PubMed 25586724Baumuller E, Schaller SJ, Chiquito Lama Y, Frick CG, Bauhofer T, Eikermann M, Fink H, Blobner M. Postoperative impairment of motor function at train-of-four ratio >/=0.9 cannot be improved by sugammadex (1 mg kg-1). Br J Anaesth. 2015 May;114(5):785-93. doi: 10.1093/bja/aeu453. Epub 2015 Jan 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.
Manfred Blobner, M.D. principal investigator
Klinik für Anaesthesiologie Klinikum München rechts der Isar
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 Sugammadex in people with Neuromuscular Blockade, run by Technical University of Munich at 1 site in Germany.
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 6 inclusion and 10 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 17 Dec 2012. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Muscle function. 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 NCT01101139, 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 17 Dec 2012.