Residual Neuromuscular Block (TOF-ratio of 0.2)SUNDRO20NCT01006720
Sugammadex and Neostigmine at Residual Neuromuscular Blockade
An observational study of Residual Neuromuscular Block (TOF-ratio of 0.2), run by Technical University of Munich at 1 site in Germany.
Trial summary
This study is designed to compare recovery times after reversal of a residual neuromuscular block (TOF-ratio 0.2) with different doses of either neostigmine or sugammadex. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Residual Neuromuscular Block (TOF-ratio of 0.2)
- What is being tested?
- Sugammadex, Neostigmine and Saline
- Type of treatment
- Injection or infusion
- How many people
- 99 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2009to Dec 2009
- 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: Patients receiving rocuronium for neuromuscular blockade under general anesthesia
Who may be able to join
- Patients ASA physical status I - III
- Patients over 18 years
- Patients scheduled for general anesthesia with intubation using rocuronium
- Patients having given informed consent to the study
Who cannot join
- Anatomic and functional malformations with expected difficult intubation
- 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 of drugs that interfere with muscle relaxants
Show all 12Show fewer
- Patients, included in another trial within the last 30 days
- Patients, with legal guidant
- Patients with contraindication towards the use of Sugammadex, neostigmine or glycopyrrolate
- Patients, which have already participated in a sugammadex trial
- Pregnant women (exclusion of pregnancy: postmenopausal status, negative β- HCG screen, status post tubal ligation)
- Breastfeeding women
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, 81675
About this study
Official title: Dose Finding Study for Sugammadex and Neostigmine at Residual Neuromuscular Blockade (T4/T1 = 0.2)
This study is designed to compare recovery times after reversal of a residual neuromuscular block (TOF-ratio 0.2) with different doses of either neostigmine or sugammadex.
Read the detailed description
Muscle relaxants are integral part of modern anesthesia. They optimize intubating conditions, reduce laryngeal trauma and improve operating conditions. Drawback is a possible pharmacological (muscle relaxing) effect of these drugs beyond the end of the operation (i.e. post-operative residual curarization: PORC). Reportedly about 30% of all patients who received muscle relaxants show signs of PORC when arriving in the post-anesthesia care unit. PORC comprises the risk of impaired post-operative fine motor and coordinative skills with a possible impairment of swallowing pharyngeal secretions with an increased risk of aspiration after extubation. Possible deleterious effects of this could be pneumonia, bronchitis, myocardial infarction, cardiac insufficiency, stroke or re-operation.
In order to avoid PORC patients with residual neuromuscular block receive a muscle relaxant antagonist from the anesthesiologist at the end of the operation. However, these drugs (neostigmine, pyridostigmine, etc.) from the class of cholinesterase inhibitors have unwanted effects such as bradycardia, increased gastro-intestinal motility, post-operative nausea and vomiting, salivation etc. To decrease these unwanted side effects cholinesterase inhibitors have to be given in combination with parasympatholyics e.g. atropine or glycopyrrolate with their own spectrum of unwanted side effects.
From October 2008 on, Sugammadex, a completely new reversal drug was introduced in to clinical practice. Sugammadex, is a modified γ-cyclodextrine able to specifically bind rocuronium (a steroidal muscle relaxant). The complex is eliminated via the kidneys. However, all studies so far have focussed on reversal of profound or deep neuromuscular blockade. This study is designed to compare recovery times after reversal of a residual neuromuscular block (TOF-ratio 0.2) with different doses of either the neostigmine or sugammadex.
- Being tested
- Sugammadex, Neostigmine, Saline
- Keywords
- Residual neuromuscular block, post-operative residual curarization, PORC, sugammadex, neostigmine
- 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.
SugammadexDrug
Single intravenous injection of either:
Sugammadex 0.25 mg/kg (Sgx 0.25) Sugammadex 0.5 mg/kg (Sgx 0.5) Sugammadex 0.75 mg/kg (Sgx 0.75) Sugammadex 1.0 mg/kg (Sgx 1.0) Sugammadex 1.25 mg/kg (Sgx 1.25)
NeostigmineDrug
Neostigmine 10 µg/kg (Neo 10) Neostigmine 25 µg/kg (Neo 25) Neostigmine 40 µg/kg (Neo 40) Neostigmine 55 µg/kg (Neo 55) Neostigmine 70 µg/kg (Neo 70)
SalineDrug
Saline 0.9% (Saline)
| Study group | Role | What they receive |
|---|---|---|
| Sgx 0.25 | Sugammadex group: Different doses of sugammadex for reversal of shallow neuromuscular blockade Receives: Drug: Sugammadex | |
| Sgx 0.5 | Sugammadex group: Different doses of sugammadex for reversal of shallow neuromuscular blockade Receives: Drug: Sugammadex | |
| Sgx 0.75 | Sugammadex group: Different doses of sugammadex for reversal of shallow neuromuscular blockade Receives: Drug: Sugammadex | |
| Sgx 1.0 | Sugammadex group: Different doses of sugammadex for reversal of shallow neuromuscular blockade Receives: Drug: Sugammadex | |
| Sgx 1.25 | Sugammadex group: Different doses of sugammadex for reversal of shallow neuromuscular blockade Receives: Drug: Sugammadex | |
| Neo 10 | Neostigmine group: Different doses of neostigmine for reversal of shallow neuromuscular blockade Receives: Drug: Neostigmine | |
| Neo 25 | Neostigmine group: Different doses of neostigmine for reversal of shallow neuromuscular blockade Receives: Drug: Neostigmine | |
| Neo 40 | Neostigmine group: Different doses of neostigmine for reversal of shallow neuromuscular blockade Receives: Drug: Neostigmine | |
| Neo 55 | Neostigmine group: Different doses of neostigmine for reversal of shallow neuromuscular blockade Receives: Drug: Neostigmine | |
| Neo 70 | Neostigmine group: Different doses of neostigmine for reversal of shallow neuromuscular blockade Receives: Drug: Neostigmine | |
| Saline | Saline group: Saline as placebo Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to TOF-ratio 0.9 following the investigational drug
Measured: Regular anesthesia time, approximately 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Residual Neuromuscular Block (TOF-ratio of 0.2)Studies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heidrun Fink, PD Dr., MD, Principal investigator, Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006720
- Sponsor's protocol ID
- SUNDRO20
- Other IDs
- EudraCT number 2009-013499-29
- Acronym
- SUNDRO20
- Status last verified
- Dec 2012
- First submitted
- 2 Nov 2009
- Last updated
- 13 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jones RK, Caldwell JE, Brull SJ, Soto RG. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology. 2008 Nov;109(5):816-24. doi: 10.1097/ALN.0b013e31818a3fee.
PubMed 18946293Puhringer 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 18648227Flockton EA, Mastronardi P, Hunter JM, Gomar C, Mirakhur RK, Aguilera L, Giunta FG, Meistelman C, Prins ME. Reversal of rocuronium-induced neuromuscular block with sugammadex is faster than reversal of cisatracurium-induced block with neostigmine. Br J Anaesth. 2008 May;100(5):622-30. doi: 10.1093/bja/aen037. Epub 2008 Apr 2.
PubMed 18385265Kaufhold N, Schaller SJ, Stauble CG, Baumuller E, Ulm K, Blobner M, Fink H. Sugammadex and neostigmine dose-finding study for reversal of residual neuromuscular block at a train-of-four ratio of 0.2 (SUNDRO20)dagger, Br J Anaesth. 2016 Feb;116(2):233-40. doi: 10.1093/bja/aev437.
PubMed 26787792
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Finding Study for Sugammadex and Neostigmine at Residual Neuromuscular Blockade (T4/T1 = 0.2)
- ClinicalTrials.gov ID
- NCT01006720
- Acronym / sponsor ID
- SUNDRO20 / SUNDRO20
- Keywords
- Residual neuromuscular block, post-operative residual curarization, PORC, sugammadex, neostigmine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 3 Nov 2009 (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 compare recovery times after reversal of a residual neuromuscular block (TOF-ratio 0.2) with different doses of either neostigmine or sugammadex.
Detailed description
Muscle relaxants are integral part of modern anesthesia. They optimize intubating conditions, reduce laryngeal trauma and improve operating conditions. Drawback is a possible pharmacological (muscle relaxing) effect of these drugs beyond the end of the operation (i.e. post-operative residual curarization: PORC). Reportedly about 30% of all patients who received muscle relaxants show signs of PORC when arriving in the post-anesthesia care unit. PORC comprises the risk of impaired post-operative fine motor and coordinative skills with a possible impairment of swallowing pharyngeal secretions with an increased risk of aspiration after extubation. Possible deleterious effects of this could be pneumonia, bronchitis, myocardial infarction, cardiac insufficiency, stroke or re-operation.
In order to avoid PORC patients with residual neuromuscular block receive a muscle relaxant antagonist from the anesthesiologist at the end of the operation. However, these drugs (neostigmine, pyridostigmine, etc.) from the class of cholinesterase inhibitors have unwanted effects such as bradycardia, increased gastro-intestinal motility, post-operative nausea and vomiting, salivation etc. To decrease these unwanted side effects cholinesterase inhibitors have to be given in combination with parasympatholyics e.g. atropine or glycopyrrolate with their own spectrum of unwanted side effects.
From October 2008 on, Sugammadex, a completely new reversal drug was introduced in to clinical practice. Sugammadex, is a modified γ-cyclodextrine able to specifically bind rocuronium (a steroidal muscle relaxant). The complex is eliminated via the kidneys. However, all studies so far have focussed on reversal of profound or deep neuromuscular blockade. This study is designed to compare recovery times after reversal of a residual neuromuscular block (TOF-ratio 0.2) with different doses of either the neostigmine or sugammadex.
Study design
- Time perspective
- Prospective
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Sgx 0.25 | – | Drug: SugammadexSugammadex group: Different doses of sugammadex for reversal of shallow neuromuscular blockade |
| Sgx 0.5 | – | Drug: SugammadexSugammadex group: Different doses of sugammadex for reversal of shallow neuromuscular blockade |
| Sgx 0.75 | – | Drug: SugammadexSugammadex group: Different doses of sugammadex for reversal of shallow neuromuscular blockade |
| Sgx 1.0 | – | Drug: SugammadexSugammadex group: Different doses of sugammadex for reversal of shallow neuromuscular blockade |
| Sgx 1.25 | – | Drug: SugammadexSugammadex group: Different doses of sugammadex for reversal of shallow neuromuscular blockade |
| Neo 10 | – | Drug: NeostigmineNeostigmine group: Different doses of neostigmine for reversal of shallow neuromuscular blockade |
| Neo 25 | – | Drug: NeostigmineNeostigmine group: Different doses of neostigmine for reversal of shallow neuromuscular blockade |
| Neo 40 | – | Drug: NeostigmineNeostigmine group: Different doses of neostigmine for reversal of shallow neuromuscular blockade |
| Neo 55 | – | Drug: NeostigmineNeostigmine group: Different doses of neostigmine for reversal of shallow neuromuscular blockade |
| Neo 70 | – | Drug: NeostigmineNeostigmine group: Different doses of neostigmine for reversal of shallow neuromuscular blockade |
| Saline | – | Drug: SalineSaline group: Saline as placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving rocuronium for neuromuscular blockade under general anesthesia
Key inclusion criteria (4 listed)
- Patients ASA physical status I - III
- Patients over 18 years
- Patients scheduled for general anesthesia with intubation using rocuronium
- Patients having given informed consent to the study
Key exclusion criteria (12 listed)
- Anatomic and functional malformations with expected difficult intubation
- 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
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 |
|---|---|---|
| SugammadexSingle intravenous injection of either: Sugammadex 0.25 mg/kg (Sgx 0.25) Sugammadex 0.5 mg/kg (Sgx 0.5) Sugammadex 0.75 mg/kg (Sgx 0.75) Sugammadex 1.0 mg/kg (Sgx 1.0) Sugammadex 1.25 mg/kg (Sgx 1.25) | Drug | Sgx 0.25, Sgx 0.5, Sgx 0.75, Sgx 1.0, Sgx 1.25 |
| NeostigmineNeostigmine 10 µg/kg (Neo 10) Neostigmine 25 µg/kg (Neo 25) Neostigmine 40 µg/kg (Neo 40) Neostigmine 55 µg/kg (Neo 55) Neostigmine 70 µg/kg (Neo 70) | Drug | Neo 10, Neo 25, Neo 40, Neo 55, Neo 70 |
| SalineSaline 0.9% (Saline) | Drug | Saline |
Primary outcome
Time to TOF-ratio 0.9 following the investigational drug
Time frame: Regular anesthesia time, approximately 1.5 hours
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 13 Dec 2012.
- Background: PubMed 18946293Jones RK, Caldwell JE, Brull SJ, Soto RG. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology. 2008 Nov;109(5):816-24. doi: 10.1097/ALN.0b013e31818a3fee.
- 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 18385265Flockton EA, Mastronardi P, Hunter JM, Gomar C, Mirakhur RK, Aguilera L, Giunta FG, Meistelman C, Prins ME. Reversal of rocuronium-induced neuromuscular block with sugammadex is faster than reversal of cisatracurium-induced block with neostigmine. Br J Anaesth. 2008 May;100(5):622-30. doi: 10.1093/bja/aen037. Epub 2008 Apr 2.
- Derived from this study: PubMed 26787792Kaufhold N, Schaller SJ, Stauble CG, Baumuller E, Ulm K, Blobner M, Fink H. Sugammadex and neostigmine dose-finding study for reversal of residual neuromuscular block at a train-of-four ratio of 0.2 (SUNDRO20)dagger, Br J Anaesth. 2016 Feb;116(2):233-40. doi: 10.1093/bja/aev437.
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.
Heidrun Fink, PD Dr., MD principal investigator
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München
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 Residual Neuromuscular Block (TOF-ratio of 0.2), 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 4 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 13 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. 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?
Time to TOF-ratio 0.9 following the investigational drug (time frame: Regular anesthesia time, approximately 1.5 hours). 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 NCT01006720, which also lists 4 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 13 Dec 2012.