Neuromuscular BlockPhase 4SUNDRONCT00895609
Sugammadex and Neostigmine at Shallow Neuromuscular Blockade
A Phase 4 study testing Sugammadex, Neostigmine, Saline in people with Neuromuscular Block, 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 0.5) with different doses of either neostigmine or sugammadex. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Neuromuscular Block
- What is being tested?
- Sugammadex, Neostigmine, Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2009to Aug 2009
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients ASA physical status I - III
- Patients between 18 and 64 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 = 0.5)
This study is designed to compare recovery times after reversal of a residual neuromuscular block (TOF-ratio 0.5) 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 anesthetist 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 gamma-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 0.5) with different doses of either the neostigmine or sugammadex.
- Conditions
- Neuromuscular Block
- Being tested
- Sugammadex, Neostigmine, Saline
- Keywords
- Residual neuromuscular block, post-operative residual curarization, PORC, sugammadex, neostigmine, Shallow neuromuscular block (TOF-ratio of 0.5)
- 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.
Sugammadex, Neostigmine, SalineDrug
Single intravenous injection of either:
Sugammadex 0.0625 mg/kg (Sgx 0.0625) Sugammadex 0.125 mg/kg (Sgx 0.125) Sugammadex 0.25 mg/kg (Sgx 0.25) Sugammadex 0.5 mg/kg (Sgx 0.5) Sugammadex 1.0 mg/kg (Sgx 1.0) Neostigmine 5 mg/kg (Neo 5) Neostigmine 8 mg/kg (Neo 8) Neostigmine 15 mg/kg (Neo 15) Neostigmine 25 mg/kg (Neo 25) Neostigmine 40 mg/kg (Neo 40) Saline 0.9% (Saline)
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex | Experimental | Sugammadex in doses: 0 (placebo), 0.0625, 0.125, 0.25, 0.5 and 1 mg/kg Receives: Drug: Sugammadex, Neostigmine, Saline |
| Neostigmine | Active comparator | Neostigmine in doses: 0 (placebo), 5, 8, 15, 25, 40 mg/kg Receives: Drug: Sugammadex, Neostigmine, 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 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2009
- Study completionAug 2009
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 Neuromuscular BlockStudies 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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Manfred Blobner, MD, Principal investigator, Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895609
- Sponsor's protocol ID
- SUNDRO
- Acronym
- SUNDRO
- Status last verified
- Mar 2013
- First submitted
- 29 Apr 2009
- Last updated
- 19 Mar 2013
- 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 18385265
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. 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 = 0.5)
- ClinicalTrials.gov ID
- NCT00895609
- Acronym / sponsor ID
- SUNDRO / SUNDRO
- Conditions
- Neuromuscular Block
- Keywords
- Residual neuromuscular block, post-operative residual curarization, PORC, sugammadex, neostigmine, Shallow neuromuscular block (TOF-ratio of 0.5)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 8 May 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 0.5) 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 anesthetist 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 gamma-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 0.5) with different doses of either the neostigmine or sugammadex.
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 |
|---|---|---|
| Sugammadex | Experimental | Drug: Sugammadex, Neostigmine, SalineSugammadex in doses: 0 (placebo), 0.0625, 0.125, 0.25, 0.5 and 1 mg/kg |
| Neostigmine | Active comparator | Drug: Sugammadex, Neostigmine, SalineNeostigmine in doses: 0 (placebo), 5, 8, 15, 25, 40 mg/kg |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients ASA physical status I - III
- Patients between 18 and 64 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 |
|---|---|---|
| Sugammadex, Neostigmine, SalineSingle intravenous injection of either: Sugammadex 0.0625 mg/kg (Sgx 0.0625) Sugammadex 0.125 mg/kg (Sgx 0.125) Sugammadex 0.25 mg/kg (Sgx 0.25) Sugammadex 0.5 mg/kg (Sgx 0.5) Sugammadex 1.0 mg/kg (Sgx 1.0) Neostigmine 5 mg/kg (Neo 5) Neostigmine 8 mg/kg (Neo 8) Neostigmine 15 mg/kg (Neo 15) Neostigmine 25 mg/kg (Neo 25) Neostigmine 40 mg/kg (Neo 40) Saline 0.9% (Saline) | Drug | Neostigmine, Sugammadex |
Primary outcome
Time to TOF-ratio 0.9 following the investigational drug
Time frame: Regular anesthesia time, approximately 1 hour
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 19 Mar 2013.
- 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.
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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, MD principal investigator
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
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, Neostigmine, Saline in people with Neuromuscular Block, 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 19 Mar 2013. 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.
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?
Time to TOF-ratio 0.9 following the investigational drug (time frame: Regular anesthesia time, approximately 1 hour). 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 NCT00895609, 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 19 Mar 2013.