Cirrhosis and Chronic Liver DiseasePhase 4NCT02414880
Sugammadex Versus Neostigmine in Patients With Liver Cirrhosis Undergoing Liver Resection
A Phase 4 study testing Sugammadex, Neostigmine and Rocuronium in people with Cirrhosis and Chronic Liver Disease, run by Cairo University at 1 site in Egypt.
Trial summary
Liver cirrhosis is a progressive disease characterized by loss of functional hepatocytes that substantially affects drug pharmacokinetics. Rocuronium onset time is longer and recovery time from it is prolonged in cirrhotic patients than in those with normal liver function. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cirrhosis and Chronic Liver Disease
- What is being tested?
- Sugammadex, Neostigmine and Rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2014to Sep 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status (ASA) class I for patients with preoperative normal liver function test (two groups) and I-III for patients with liver cirrhosis (two groups).
- For the two "Liver Cirrhosis" groups: Patients with liver Cirrhosis with Child classification "A" and a Model for End-Stage Liver Disease (MELD) score <10 undergoing Liver resection surgeries.
- For the two "Normal Liver" groups: Patients with normal preoperative liver functions undergoing Liver resection surgeries.
Who cannot join
- Co-existing neuromuscular disease.
- Body mass index more than 35 kg/m-2.
- Renal impairment.
- Medications known to affect neuromuscular transmission (e.g. Aminoglycoside antibiotics or Magnesium Sulphate).
- Bleeding tendency.
- Intra-operative adverse events (e.g. massive bleeding or hypothermia).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
National Liver institute
Ḩadā’iq al Qubbah, Cairo Governorate, 11562
About this study
Official title: Sugammadex Versus Neostigmine for Antagonism of Rocuronium-induced Neuromuscular Blockade in Patients With Liver Cirrhosis Undergoing Liver Resection: A Controlled Randomized Study
Liver cirrhosis is a progressive disease characterized by loss of functional hepatocytes that substantially affects drug pharmacokinetics. Rocuronium onset time is longer and recovery time from it is prolonged in cirrhotic patients than in those with normal liver function.
This randomized controlled study is designed to compare the pharmacodynamic profiles of sugammadex and neostigmine when used for the antagonism of moderate degree of rocuronium-induced neuromuscular block in cirrhotic patients undergoing liver resection and in patients with preoperative normal liver functions undergoing liver resection.
Read the detailed description
Liver resection is a lengthy operation that has major effects on patient hemodynamics and perioperative liver functions. These effects are more obvious in patients with liver cirrhosis. Liver cirrhosis is a progressive disease characterized by loss of functional hepatocytes that substantially affects drug pharmacokinetics.
Rocuronium is an intermediate acting steroidal non-depolarizing neuromuscular blocker that is mostly metabolized by the liver. Its onset time is longer in cirrhotic patients than in those with normal liver function. This can be explained by an increase in the volume in which it initially distributes. Although elimination kinetics are unchanged in patients with cirrhosis, Rocuronium recovery time is prolonged in cirrhotic patients.
To speed up the process of antagonism of residual neuromuscular blockade, inhibitors of acetyl cholinesterases such as Neostigmine are usually administered only when there is evidence of spontaneous recovery of neuromuscular function. Too early administration of Neostigmine is not effective and may produce serious side-effects from accumulation of Acetylcholine in other organs, especially the brain and heart.
Sugammadex, a modified γ-cyclodextrin, is the first selective relaxant binding agent. It forms very tight, stable complexes in a 1:1 ratio with Rocuronium. The inactive Sugammadex-Rocuronium complex undergoes renal elimination. Sugammadex has no effect on acetyl cholinesterases or on any receptor system in the body, eliminating the need for anticholinergic drugs. Sugammadex can antagonize any level of neuromuscular blockade, including the profound blockade induced by Rocuronium.
The use of Sugammadex in different patient populations including end-stage renal failure is associated with consistent, complete and rapid recovery of neuromuscular functions. It is of clinical relevance to note that in the presence of Sugammadex, the hepatic biotransformation and final clearance of Rocuronium via biliary excretion is changed to a completely different (liver-independent) renal pathway. A recent report described the successful use of Sugammadex to antagonize prolonged deep rocuronium-induced neuromuscular block in patients with normal liver functions undergoing liver resection. Furthermore, the successful use of Sugammadex to antagonize Rocuronium neuromuscular block was also reported in a case series of three patients with liver dysfunction.
To the best of our knowledge, there are no controlled randomized studies evaluating the use of Sugammadex to antagonize residual Rocuronium-induced neuromuscular blockade in patients with liver cirrhosis undergoing open surgical liver resection. This randomized controlled study is designed to compare the pharmacodynamic profiles of Sugammadex and Neostigmine when used for the antagonism of moderate degree of Rocuronium-induced neuromuscular block in cirrhotic patients undergoing liver resection and in patients with preoperative normal liver functions undergoing liver resection.
- Conditions
- Cirrhosis and Chronic Liver Disease
- Being tested
- Sugammadex, Neostigmine, Rocuronium
- Keywords
- Sugammadex, Neostigmine, Rocuronium, Cirrhosis, Liver resection, Neuromuscular
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Also called Bridion
Rocuronium-induced neuromuscular blockade will be reversed at the end of the operation when two responses to train-of-four ulnar nerve stimulation are detected (T2) by injection of sugammadex 2mg/kg.
NeostigmineDrug
Also called Prostigmine
Rocuronium-induced neuromuscular blockade will be reversed at the end of the operation when two responses to train-of-four ulnar nerve stimulation are detected (T2) by injection of neostigmine 50 micro-gram/kg combined with atropine 20 micro-gram/kg.
RocuroniumDrug
Also called Esmeron
An intubating dose of Rocuronium (0.6 mg/kg) will be given with induction of anesthesia and the degree of muscle relaxation will be evaluated through out the operation by recording the response of the hand muscles to train-of-four ulnar nerve stimulator (Mechanosensor Neuromuscular Transmission Module of General Electric AISYS Anaesthesia machine USA) according to the Good Clinical Research Practice (GCRP) guidelines for pharmacodynamic neuromuscular studies. Muscle relaxation will be maintained by additional top-up doses of Rocuronium (0.15mg/kg) which will be administered after detection of the first response to TOF stimulation (T1).
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex/ Normal liver | Active comparator | Patients with American Society of Anesthesiologists physical status (ASA) class I with normal preoperative liver functions undergoing liver resection.
Rocuronium-induced neuromuscular blockade will be reversed at the end of the operation when two responses to train-of-four ulnar nerve stimulation are detected (T2) by injection of sugammadex 2mg/kg. Receives: Drug: Sugammadex; Drug: Rocuronium |
| Neostigmine / Normal liver | Active comparator | Patients with American Society of Anesthesiologists physical status (ASA) class I with normal preoperative liver functions undergoing liver resection.
Rocuronium-induced neuromuscular blockade will be reversed at the end of the operation when two responses to train-of-four ulnar nerve stimulation are detected (T2) by injection of neostigmine 50 micro-gram/kg combined with atropine 20 micro-gram/kg. Receives: Drug: Neostigmine; Drug: Rocuronium |
| Sugammadex / Liver cirrhosis | Active comparator | Patients with liver cirrhosis, Child classification "A" with a Model for End-Stage Liver Disease (MELD) score <10 undergoing liver resection.
Rocuronium-induced neuromuscular blockade will be reversed at the end of the operation when two responses to train-of-four ulnar nerve stimulation are detected (T2) by injection of sugammadex 2mg/kg. Receives: Drug: Sugammadex; Drug: Rocuronium |
| Neostigmine / Liver cirrhosis | Active comparator | Patients with liver cirrhosis, Child classification "A" with a Model for End-Stage Liver Disease (MELD) score <10 undergoing liver resection.
Rocuronium-induced neuromuscular blockade will be reversed at the end of the operation when two responses to train-of-four ulnar nerve stimulation are detected (T2) by injection of neostigmine 50 micro-gram/kg combined with atropine 20 micro-gram/kg. Receives: Drug: Neostigmine; Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time from reversal to Train-of-four (TOF) ratio of 0.9
The time from the administration of Sugammadex or Neostigmine till recovery of the TOF ratio to 0.9
Measured: 15 min
Secondary outcomes (7)
The time from reversal to Train-of-four (TOF) ratio of 1
The time from the administration of Sugammadex or Neostigmine till recovery of the TOF ratio to 1.
Measured: 30 min
Length of stay in the post-anesthesia care unit (PACU)
Time required in post-anesthesia care unit (PACU) to achieve a modified Aldrete score of 9
Measured: 4 hours
Time from last Rocuronium dose to Train-of-four (TOF) ratio of 0.9
The time from the last dose of Rocuronium to recovery of the TOF ratio to 0.9.
Measured: 1 hour
Duration of action of the initial intubating dose of Rocuronium
The time interval between the initial Rocuronium intubating dose administration and the recovery of the first twitch of the TOF response (T1).
Measured: 45 min
Incidence of postoperative re-curarization
Recurrence of neuromuscular block (re-curarization) will be defined as a decrease in the TOF ratio to <0.9 after full recovery had been detected, or as a deterioration in the clinical signs of recovery from the block.
Measured: 4 hours
Total dose of Rocuronium
Total dose of Rocuronium used during the whole operation including the intubating dose and the subsequent top-ups.
Measured: 24 hours
Duration of anesthesia
Duration between induction of anesthesia and complete recovery of consciousness and motor power.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2015 (estimated)
- Study startDec 2014
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis and Chronic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- National Liver Institute, Egypt
- Responsible party
- Principal investigator, Professor Mohamed Abdulatif Mohamed, Cairo University
- Investigators
- Mohamed Abdulatif Mohamed, M.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414880
- Sponsor's protocol ID
- Suga-Neo
- Status last verified
- Jan 2016
- First submitted
- 5 Apr 2015
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schaller SJ, Fink H. Sugammadex as a reversal agent for neuromuscular block: an evidence-based review. Core Evid. 2013;8:57-67. doi: 10.2147/CE.S35675. Epub 2013 Sep 25.
PubMed 24098155Edginton AN, Willmann S. Physiology-based simulations of a pathological condition: prediction of pharmacokinetics in patients with liver cirrhosis. Clin Pharmacokinet. 2008;47(11):743-52. doi: 10.2165/00003088-200847110-00005.
PubMed 18840029Kopman AF, Eikermann M. Antagonism of non-depolarising neuromuscular block: current practice. Anaesthesia. 2009 Mar;64 Suppl 1:22-30. doi: 10.1111/j.1365-2044.2008.05867.x.
PubMed 19222428Caldwell JE. Clinical limitations of acetylcholinesterase antagonists. J Crit Care. 2009 Mar;24(1):21-8. doi: 10.1016/j.jcrc.2008.08.003. Epub 2009 Jan 17.
PubMed 19272535Naguib M. Sugammadex: another milestone in clinical neuromuscular pharmacology. Anesth Analg. 2007 Mar;104(3):575-81. doi: 10.1213/01.ane.0000244594.63318.fc.
PubMed 17312211Nonaka T, Fujimoto M, Nishi M, Yamamoto T. [The effect of rocuronium and sugammadex in hepatic tumor patients without preoperative hepatic impairment]. Masui. 2013 Mar;62(3):304-8. Japanese.
PubMed 23544332Batistaki C, Matsota P, Kalimeris K, Brountzos E, Kostopanagiotou G. Sugammadex antagonising rocuronium in three patients with liver dysfunction undergoing transjugular intrahepatic portosystemic shunt. Anaesth Intensive Care. 2012 May;40(3):556-7. No abstract available.
PubMed 22577926Blobner M, Eriksson LI, Scholz J, Motsch J, Della Rocca G, Prins ME. Reversal of rocuronium-induced neuromuscular blockade with sugammadex compared with neostigmine during sevoflurane anaesthesia: results of a randomised, controlled trial. Eur J Anaesthesiol. 2010 Oct;27(10):874-81. doi: 10.1097/EJA.0b013e32833d56b7.
PubMed 20683334Illman HL, Laurila P, Antila H, Meretoja OA, Alahuhta S, Olkkola KT. The duration of residual neuromuscular block after administration of neostigmine or sugammadex at two visible twitches during train-of-four monitoring. Anesth Analg. 2011 Jan;112(1):63-8. doi: 10.1213/ANE.0b013e3181fdf889. Epub 2010 Oct 26.
PubMed 20978247
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sugammadex Versus Neostigmine for Antagonism of Rocuronium-induced Neuromuscular Blockade in Patients With Liver Cirrhosis Undergoing Liver Resection: A Controlled Randomized Study
- ClinicalTrials.gov ID
- NCT02414880
- Acronym / sponsor ID
- Suga-Neo
- Conditions
- Cirrhosis and Chronic Liver Disease
- Keywords
- Sugammadex, Neostigmine, Rocuronium, Cirrhosis, Liver resection, Neuromuscular
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- National Liver Institute, Egypt
- Study start
- Dec 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Apr 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.
Liver cirrhosis is a progressive disease characterized by loss of functional hepatocytes that substantially affects drug pharmacokinetics. Rocuronium onset time is longer and recovery time from it is prolonged in cirrhotic patients than in those with normal liver function.
This randomized controlled study is designed to compare the pharmacodynamic profiles of sugammadex and neostigmine when used for the antagonism of moderate degree of rocuronium-induced neuromuscular block in cirrhotic patients undergoing liver resection and in patients with preoperative normal liver functions undergoing liver resection.
Detailed description
Liver resection is a lengthy operation that has major effects on patient hemodynamics and perioperative liver functions. These effects are more obvious in patients with liver cirrhosis. Liver cirrhosis is a progressive disease characterized by loss of functional hepatocytes that substantially affects drug pharmacokinetics.
Rocuronium is an intermediate acting steroidal non-depolarizing neuromuscular blocker that is mostly metabolized by the liver. Its onset time is longer in cirrhotic patients than in those with normal liver function. This can be explained by an increase in the volume in which it initially distributes. Although elimination kinetics are unchanged in patients with cirrhosis, Rocuronium recovery time is prolonged in cirrhotic patients.
To speed up the process of antagonism of residual neuromuscular blockade, inhibitors of acetyl cholinesterases such as Neostigmine are usually administered only when there is evidence of spontaneous recovery of neuromuscular function. Too early administration of Neostigmine is not effective and may produce serious side-effects from accumulation of Acetylcholine in other organs, especially the brain and heart.
Sugammadex, a modified γ-cyclodextrin, is the first selective relaxant binding agent. It forms very tight, stable complexes in a 1:1 ratio with Rocuronium. The inactive Sugammadex-Rocuronium complex undergoes renal elimination. Sugammadex has no effect on acetyl cholinesterases or on any receptor system in the body, eliminating the need for anticholinergic drugs. Sugammadex can antagonize any level of neuromuscular blockade, including the profound blockade induced by Rocuronium.
The use of Sugammadex in different patient populations including end-stage renal failure is associated with consistent, complete and rapid recovery of neuromuscular functions. It is of clinical relevance to note that in the presence of Sugammadex, the hepatic biotransformation and final clearance of Rocuronium via biliary excretion is changed to a completely different (liver-independent) renal pathway. A recent report described the successful use of Sugammadex to antagonize prolonged deep rocuronium-induced neuromuscular block in patients with normal liver functions undergoing liver resection. Furthermore, the successful use of Sugammadex to antagonize Rocuronium neuromuscular block was also reported in a case series of three patients with liver dysfunction.
To the best of our knowledge, there are no controlled randomized studies evaluating the use of Sugammadex to antagonize residual Rocuronium-induced neuromuscular blockade in patients with liver cirrhosis undergoing open surgical liver resection. This randomized controlled study is designed to compare the pharmacodynamic profiles of Sugammadex and Neostigmine when used for the antagonism of moderate degree of Rocuronium-induced neuromuscular block in cirrhotic patients undergoing liver resection and in patients with preoperative normal liver functions undergoing liver resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sugammadex/ Normal liver | Active comparator | Drug: Sugammadex, Drug: RocuroniumPatients with American Society of Anesthesiologists physical status (ASA) class I with normal preoperative liver functions undergoing liver resection. Rocuronium-induced neuromuscular blockade will be reversed at the end of the operation when two responses to train-of-four ulnar nerve stimulation are detected (T2) by injection of sugammadex 2mg/kg. |
| Neostigmine / Normal liver | Active comparator | Drug: Neostigmine, Drug: RocuroniumPatients with American Society of Anesthesiologists physical status (ASA) class I with normal preoperative liver functions undergoing liver resection. Rocuronium-induced neuromuscular blockade will be reversed at the end of the operation when two responses to train-of-four ulnar nerve stimulation are detected (T2) by injection of neostigmine 50 micro-gram/kg combined with atropine 20 micro-gram/kg. |
| Sugammadex / Liver cirrhosis | Active comparator | Drug: Sugammadex, Drug: RocuroniumPatients with liver cirrhosis, Child classification "A" with a Model for End-Stage Liver Disease (MELD) score <10 undergoing liver resection. Rocuronium-induced neuromuscular blockade will be reversed at the end of the operation when two responses to train-of-four ulnar nerve stimulation are detected (T2) by injection of sugammadex 2mg/kg. |
| Neostigmine / Liver cirrhosis | Active comparator | Drug: Neostigmine, Drug: RocuroniumPatients with liver cirrhosis, Child classification "A" with a Model for End-Stage Liver Disease (MELD) score <10 undergoing liver resection. Rocuronium-induced neuromuscular blockade will be reversed at the end of the operation when two responses to train-of-four ulnar nerve stimulation are detected (T2) by injection of neostigmine 50 micro-gram/kg combined with atropine 20 micro-gram/kg. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists physical status (ASA) class I for patients with preoperative normal liver function test (two groups) and I-III for patients with liver cirrhosis (two groups).
- For the two "Liver Cirrhosis" groups: Patients with liver Cirrhosis with Child classification "A" and a Model for End-Stage Liver Disease (MELD) score <10 undergoing Liver resection surgeries.
- For the two "Normal Liver" groups: Patients with normal preoperative liver functions undergoing Liver resection surgeries.
Key exclusion criteria (6 listed)
- Co-existing neuromuscular disease.
- Body mass index more than 35 kg/m-2.
- Renal impairment.
- Medications known to affect neuromuscular transmission (e.g. Aminoglycoside antibiotics or Magnesium Sulphate).
- Bleeding tendency.
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 |
|---|---|---|
| SugammadexAlso: BridionRocuronium-induced neuromuscular blockade will be reversed at the end of the operation when two responses to train-of-four ulnar nerve stimulation are detected (T2) by injection of sugammadex 2mg/kg. | Drug | Sugammadex / Liver cirrhosis, Sugammadex/ Normal liver |
| NeostigmineAlso: ProstigmineRocuronium-induced neuromuscular blockade will be reversed at the end of the operation when two responses to train-of-four ulnar nerve stimulation are detected (T2) by injection of neostigmine 50 micro-gram/kg combined with atropine 20 micro-gram/kg. | Drug | Neostigmine / Liver cirrhosis, Neostigmine / Normal liver |
| RocuroniumAlso: EsmeronAn intubating dose of Rocuronium (0.6 mg/kg) will be given with induction of anesthesia and the degree of muscle relaxation will be evaluated through out the operation by recording the response of the hand muscles to train-of-four ulnar nerve stimulator (Mechanosensor Neuromuscular Transmission Module of General Electric AISYS Anaesthesia machine USA) according to the Good Clinical Research Practice (GCRP) guidelines for pharmacodynamic neuromuscular studies. Muscle relaxation will be maintained by additional top-up doses of Rocuronium (0.15mg/kg) which will be administered after detection of the first response to TOF stimulation (T1). | Drug | Neostigmine / Liver cirrhosis, Neostigmine / Normal liver, Sugammadex / Liver cirrhosis, Sugammadex/ Normal liver |
Primary outcome
The time from reversal to Train-of-four (TOF) ratio of 0.9
Time frame: 15 min
The time from the administration of Sugammadex or Neostigmine till recovery of the TOF ratio to 0.9
7 secondary outcomes
The time from reversal to Train-of-four (TOF) ratio of 1
Time frame: 30 min
Length of stay in the post-anesthesia care unit (PACU)
Time frame: 4 hours
Time from last Rocuronium dose to Train-of-four (TOF) ratio of 0.9
Time frame: 1 hour
Duration of action of the initial intubating dose of Rocuronium
Time frame: 45 min
Incidence of postoperative re-curarization
Time frame: 4 hours
Total dose of Rocuronium
Time frame: 24 hours
Duration of anesthesia
Time frame: 24 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 2 Feb 2016.
- Background: PubMed 24098155Schaller SJ, Fink H. Sugammadex as a reversal agent for neuromuscular block: an evidence-based review. Core Evid. 2013;8:57-67. doi: 10.2147/CE.S35675. Epub 2013 Sep 25.
- Background: PubMed 18840029Edginton AN, Willmann S. Physiology-based simulations of a pathological condition: prediction of pharmacokinetics in patients with liver cirrhosis. Clin Pharmacokinet. 2008;47(11):743-52. doi: 10.2165/00003088-200847110-00005.
- Background: PubMed 19222428Kopman AF, Eikermann M. Antagonism of non-depolarising neuromuscular block: current practice. Anaesthesia. 2009 Mar;64 Suppl 1:22-30. doi: 10.1111/j.1365-2044.2008.05867.x.
- Background: PubMed 19272535Caldwell JE. Clinical limitations of acetylcholinesterase antagonists. J Crit Care. 2009 Mar;24(1):21-8. doi: 10.1016/j.jcrc.2008.08.003. Epub 2009 Jan 17.
- Background: PubMed 17312211Naguib M. Sugammadex: another milestone in clinical neuromuscular pharmacology. Anesth Analg. 2007 Mar;104(3):575-81. doi: 10.1213/01.ane.0000244594.63318.fc.
- Background: PubMed 23544332Nonaka T, Fujimoto M, Nishi M, Yamamoto T. [The effect of rocuronium and sugammadex in hepatic tumor patients without preoperative hepatic impairment]. Masui. 2013 Mar;62(3):304-8. Japanese.
- Background: PubMed 22577926Batistaki C, Matsota P, Kalimeris K, Brountzos E, Kostopanagiotou G. Sugammadex antagonising rocuronium in three patients with liver dysfunction undergoing transjugular intrahepatic portosystemic shunt. Anaesth Intensive Care. 2012 May;40(3):556-7. No abstract available.
- Background: PubMed 20683334Blobner M, Eriksson LI, Scholz J, Motsch J, Della Rocca G, Prins ME. Reversal of rocuronium-induced neuromuscular blockade with sugammadex compared with neostigmine during sevoflurane anaesthesia: results of a randomised, controlled trial. Eur J Anaesthesiol. 2010 Oct;27(10):874-81. doi: 10.1097/EJA.0b013e32833d56b7.
- Background: PubMed 20978247Illman HL, Laurila P, Antila H, Meretoja OA, Alahuhta S, Olkkola KT. The duration of residual neuromuscular block after administration of neostigmine or sugammadex at two visible twitches during train-of-four monitoring. Anesth Analg. 2011 Jan;112(1):63-8. doi: 10.1213/ANE.0b013e3181fdf889. Epub 2010 Oct 26.
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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.
Mohamed Abdulatif Mohamed, M.D. principal investigator
Cairo University
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 and Rocuronium in people with Cirrhosis and Chronic Liver Disease, run by Cairo University at 1 site in Egypt.
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 3 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 2 Feb 2016. 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 Egypt. 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?
The time from reversal to Train-of-four (TOF) ratio of 0.9 (time frame: 15 min). 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 NCT02414880, which also lists 9 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 2 Feb 2016.