Postoperative Residual CurarizationNCT02697929
Sugammadex/Neostigmine and Liver Transplantation
A study testing sugammadex and Neostigmine in people with Postoperative Residual Curarization and Liver Transplantation, run by Azienda Ospedaliera S. Maria della Misericordia at 1 site in Italy.
Trial summary
Cirrhotic patients undergoing liver transplantation are at very high risk of post operative complication such as post-operative residual curarization. Rocuronium is a neuromuscular blocking agent that nowadays can be safely and rapidly antagonized with sugammadex. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Residual Curarization, Liver Transplantation
- What is being tested?
- sugammadex and Neostigmine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Jan 2019
- Phase
- Interventional
- 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
Who may be able to join
- American Society of Anesthesiology status (ASA) III
- Ability to give a written informed consent
- Liver transplantation
Who cannot join
- Any allergy to medications involved in the study
- Any disease involving neuromuscular transmission
- Any therapy with toremifene, flucloxacillin or fusidic acid
- Renal disease with glomerular filtration rate less than 30 ml/min/1.73m2
- Hyperthermia maligna
- Anticonceptional therapy
- Pregnancy
- Core body temperature less than 35°C or skin temperature less than 32°C at the end of surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sugammadex Versus Neostigmine After Rocuronium Infusion During Liver Transplantation
Cirrhotic patients undergoing liver transplantation are at very high risk of post operative complication such as post-operative residual curarization.
Rocuronium is a neuromuscular blocking agent that nowadays can be safely and rapidly antagonized with sugammadex.
No one study compared sugammadex versus neostigmine after rocuronium infusion during liver transplantation.
Read the detailed description
It is known that major abdominal surgery is associated with increased risk of morbidity and postoperative mortality. The complexity and the duration of the procedure as well as the failure to antagonize neuromuscular blocking agents at the end of surgical procedure are risk factors for postoperative complications.
Muscle relaxation plays an important role that is to facilitate intubation and to allow a better surgical condition. For this reason it is necessary to maintain, during the surgery, a deep neuromuscular block.
Deep block at the level of the adductor muscle of the thumb is obtained by measuring 1-2 responses during post-tetanic stimulation (the so-called Post-Tetanic Count or PTC).
The maintenance of a deep neuromuscular block requires further doses of neuromuscular blockers and, therefore, the need of long recovery times regardless of the drug used.
Pharmacodynamics and pharmacokinetics of neuromuscular blocking and reversals commonly used in clinical practice can undergo significant changes due to the presence of alterations in organ function such as hepatic and renal insufficiency. In these patients we see more frequent adverse events such as prolonged neuromuscular blockade and postoperative residual curarization.
In the literature it is considered suitable a recovery from neuromuscular block if the relationship between the fourth and first contraction during Train of Four (TOF) is greater than 0.9 (TOF-ratio> 0.9). This may take a long time so the reversal of blocking agents at the end of the surgical procedure is the solution to reduce this waiting period. The importance of an adequate recovery from neuromuscular block at the end of anesthesia is related to avoid postoperative residual paralysis (PORC) and reducing the risk of postoperative respiratory complications potentially fatal.
Rocuronium is characterized by an increase in half-life and an increase in the recovery time of neuromuscular transmission (TOF ratio of 0.9) in cirrhotic patients compared to controls healthy people.
To prevent residual neuromuscular blockade and all the complications that it brings with it it could be resorted the use of anti-cholinesterase drugs (neostigmine) to antagonize indirectly the action of non-depolarizing neuromuscular blocking agents. Neostigmine works by increasing the availability of acetylcholine at the neuromuscular junction. The administration of neostigmine may however cause bronchospasm, abdominal pain, nausea, cardiac arrhythmias and can not be used if the neuromuscular blockade is deep. Recently the use of sugammadex, a new drug that can act as an antidote to a comparison of non-depolarizing muscle relaxants amino-steroidal (rocuronium, vecuronium) showed good clinical impact. This drug works by encapsulating the muscle relaxant molecule in the plasma with a high affinity and binding to the complex thus formed which is then eliminated by the kidney. Sugammadex is characterized by the absence of adverse effects at the recommended doses and may be administered at correct dosage, even at deep neuromuscular blockade.
Several studies have shown that the recovery from neuromuscular blockade induced by rocuronium is significantly faster after administration of sugammadex compared with neostigmine both when used in moderate block levels and deep.
In literature there are no data and studies that assessed the recovery time of neuromuscular transmission (TOF ratio> 0.9) with the use of sugammadex verus neostigmine in patients undergoing liver transplantation after rocuronium infusion.
- Being tested
- sugammadex, Neostigmine
- Keywords
- Rocuronium
- 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
NeostigmineDrug
| Study group | Role | What they receive |
|---|---|---|
| sugammadex | Active comparator | at the end of surgery administration of 2 mg/kg of sugammadex after the third T2 twitch at Train of Four (TOF) stimulation Receives: Drug: sugammadex |
| neostigmine | Active comparator | at the end of surgery administration of 50 mcg/kg of neostigmine after the third T2 twitch at Train of Four (TOF) stimulation Receives: Drug: Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time from moderate neuromuscular block to a TOF ratio more than 0.9 after administration of sugammadex or neostigmine using TOF-Watch SX.
Measured: 30 minutes
Secondary outcomes (1)
Any episode PORC (defined as TOF ratio less than 0.9) within 20 minutes after extubation of the patient using TOF-Watch SX.
Measured: 20 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 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative Residual CurarizationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera S. Maria della Misericordia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Livia Pompei, Azienda Ospedaliera S. Maria della Misericordia
- Investigators
- livia pompei, MD, Principal investigator, AOU Santa Maria Della Misercordiagiorgio della rocca, FP, MD, Study director, AOU Santa Maria Della Misercordia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697929
- Sponsor's protocol ID
- SugNeoLTx1.0
- Status last verified
- Sep 2021
- First submitted
- 13 Feb 2016
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Arbous MS, Meursing AE, van Kleef JW, de Lange JJ, Spoormans HH, Touw P, Werner FM, Grobbee DE. Impact of anesthesia management characteristics on severe morbidity and mortality. Anesthesiology. 2005 Feb;102(2):257-68; quiz 491-2. doi: 10.1097/00000542-200502000-00005.
PubMed 15681938Craig RG, Hunter JM. Neuromuscular blocking drugs and their antagonists in patients with organ disease. Anaesthesia. 2009 Mar;64 Suppl 1:55-65. doi: 10.1111/j.1365-2044.2008.05871.x.
PubMed 19222432van Miert MM, Eastwood NB, Boyd AH, Parker CJ, Hunter JM. The pharmacokinetics and pharmacodynamics of rocuronium in patients with hepatic cirrhosis. Br J Clin Pharmacol. 1997 Aug;44(2):139-44. doi: 10.1046/j.1365-2125.1997.00653.x.
PubMed 9278198Khalil M, D'Honneur G, Duvaldestin P, Slavov V, De Hys C, Gomeni R. Pharmacokinetics and pharmacodynamics of rocuronium in patients with cirrhosis. Anesthesiology. 1994 Jun;80(6):1241-7. doi: 10.1097/00000542-199406000-00011.
PubMed 8010470Jones 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 18946293Deana C, Barbariol F, D'Inca S, Pompei L, Rocca GD. SUGAMMADEX versus neostigmine after ROCURONIUM continuous infusion in patients undergoing liver transplantation. BMC Anesthesiol. 2020 Mar 25;20(1):70. doi: 10.1186/s12871-020-00986-z.
PubMed 32213163
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sugammadex Versus Neostigmine After Rocuronium Infusion During Liver Transplantation
- ClinicalTrials.gov ID
- NCT02697929
- Acronym / sponsor ID
- SugNeoLTx1.0
- Keywords
- Rocuronium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Azienda Ospedaliera S. Maria della MisericordiaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 3 Mar 2016 (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.
Cirrhotic patients undergoing liver transplantation are at very high risk of post operative complication such as post-operative residual curarization.
Rocuronium is a neuromuscular blocking agent that nowadays can be safely and rapidly antagonized with sugammadex.
No one study compared sugammadex versus neostigmine after rocuronium infusion during liver transplantation.
Detailed description
It is known that major abdominal surgery is associated with increased risk of morbidity and postoperative mortality. The complexity and the duration of the procedure as well as the failure to antagonize neuromuscular blocking agents at the end of surgical procedure are risk factors for postoperative complications.
Muscle relaxation plays an important role that is to facilitate intubation and to allow a better surgical condition. For this reason it is necessary to maintain, during the surgery, a deep neuromuscular block.
Deep block at the level of the adductor muscle of the thumb is obtained by measuring 1-2 responses during post-tetanic stimulation (the so-called Post-Tetanic Count or PTC).
The maintenance of a deep neuromuscular block requires further doses of neuromuscular blockers and, therefore, the need of long recovery times regardless of the drug used.
Pharmacodynamics and pharmacokinetics of neuromuscular blocking and reversals commonly used in clinical practice can undergo significant changes due to the presence of alterations in organ function such as hepatic and renal insufficiency. In these patients we see more frequent adverse events such as prolonged neuromuscular blockade and postoperative residual curarization.
In the literature it is considered suitable a recovery from neuromuscular block if the relationship between the fourth and first contraction during Train of Four (TOF) is greater than 0.9 (TOF-ratio> 0.9). This may take a long time so the reversal of blocking agents at the end of the surgical procedure is the solution to reduce this waiting period. The importance of an adequate recovery from neuromuscular block at the end of anesthesia is related to avoid postoperative residual paralysis (PORC) and reducing the risk of postoperative respiratory complications potentially fatal.
Rocuronium is characterized by an increase in half-life and an increase in the recovery time of neuromuscular transmission (TOF ratio of 0.9) in cirrhotic patients compared to controls healthy people.
To prevent residual neuromuscular blockade and all the complications that it brings with it it could be resorted the use of anti-cholinesterase drugs (neostigmine) to antagonize indirectly the action of non-depolarizing neuromuscular blocking agents. Neostigmine works by increasing the availability of acetylcholine at the neuromuscular junction. The administration of neostigmine may however cause bronchospasm, abdominal pain, nausea, cardiac arrhythmias and can not be used if the neuromuscular blockade is deep. Recently the use of sugammadex, a new drug that can act as an antidote to a comparison of non-depolarizing muscle relaxants amino-steroidal (rocuronium, vecuronium) showed good clinical impact. This drug works by encapsulating the muscle relaxant molecule in the plasma with a high affinity and binding to the complex thus formed which is then eliminated by the kidney. Sugammadex is characterized by the absence of adverse effects at the recommended doses and may be administered at correct dosage, even at deep neuromuscular blockade.
Several studies have shown that the recovery from neuromuscular blockade induced by rocuronium is significantly faster after administration of sugammadex compared with neostigmine both when used in moderate block levels and deep.
In literature there are no data and studies that assessed the recovery time of neuromuscular transmission (TOF ratio> 0.9) with the use of sugammadex verus neostigmine in patients undergoing liver transplantation after rocuronium infusion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sugammadex | Active comparator | Drug: sugammadexat the end of surgery administration of 2 mg/kg of sugammadex after the third T2 twitch at Train of Four (TOF) stimulation |
| neostigmine | Active comparator | Drug: Neostigmineat the end of surgery administration of 50 mcg/kg of neostigmine after the third T2 twitch at Train of Four (TOF) stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiology status (ASA) III
- Ability to give a written informed consent
- Liver transplantation
Key exclusion criteria (8 listed)
- Any allergy to medications involved in the study
- Any disease involving neuromuscular transmission
- Any therapy with toremifene, flucloxacillin or fusidic acid
- Renal disease with glomerular filtration rate less than 30 ml/min/1.73m2
- Hyperthermia maligna
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 | Drug | sugammadex |
| Neostigmine | Drug | neostigmine |
Primary outcome
Recovery time from moderate neuromuscular block to a TOF ratio more than 0.9 after administration of sugammadex or neostigmine using TOF-Watch SX.
Time frame: 30 minutes
1 secondary outcome
Any episode PORC (defined as TOF ratio less than 0.9) within 20 minutes after extubation of the patient using TOF-Watch SX.
Time frame: 20 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 21 Sep 2021.
- Background: PubMed 15681938Arbous MS, Meursing AE, van Kleef JW, de Lange JJ, Spoormans HH, Touw P, Werner FM, Grobbee DE. Impact of anesthesia management characteristics on severe morbidity and mortality. Anesthesiology. 2005 Feb;102(2):257-68; quiz 491-2. doi: 10.1097/00000542-200502000-00005.
- Background: PubMed 19222432Craig RG, Hunter JM. Neuromuscular blocking drugs and their antagonists in patients with organ disease. Anaesthesia. 2009 Mar;64 Suppl 1:55-65. doi: 10.1111/j.1365-2044.2008.05871.x.
- Background: PubMed 9278198van Miert MM, Eastwood NB, Boyd AH, Parker CJ, Hunter JM. The pharmacokinetics and pharmacodynamics of rocuronium in patients with hepatic cirrhosis. Br J Clin Pharmacol. 1997 Aug;44(2):139-44. doi: 10.1046/j.1365-2125.1997.00653.x.
- Background: PubMed 8010470Khalil M, D'Honneur G, Duvaldestin P, Slavov V, De Hys C, Gomeni R. Pharmacokinetics and pharmacodynamics of rocuronium in patients with cirrhosis. Anesthesiology. 1994 Jun;80(6):1241-7. doi: 10.1097/00000542-199406000-00011.
- 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.
- Derived from this study: PubMed 32213163Deana C, Barbariol F, D'Inca S, Pompei L, Rocca GD. SUGAMMADEX versus neostigmine after ROCURONIUM continuous infusion in patients undergoing liver transplantation. BMC Anesthesiol. 2020 Mar 25;20(1):70. doi: 10.1186/s12871-020-00986-z.
- Individual participant dataSharing planned: Undecided
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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.
livia pompei, MD principal investigator
AOU Santa Maria Della Misercordia
giorgio della rocca, FP, MD study director
AOU Santa Maria Della Misercordia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sugammadex and Neostigmine in people with Postoperative Residual Curarization and Liver Transplantation, run by Azienda Ospedaliera S. Maria della Misericordia at 1 site in Italy.
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 8 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 21 Sep 2021. 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 Italy. 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?
Recovery time from moderate neuromuscular block to a TOF ratio more than 0.9 after administration of sugammadex or neostigmine using TOF-Watch SX. (time frame: 30 minutes). 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 NCT02697929, which also lists 6 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 21 Sep 2021.