Neuromuscular BlockadeNCT03656614
Reversal of Residual Neuromuscular Blockade at Train-of-four Ratio 0.3 With Sugammadex and Neostigmine
An observational study of Neuromuscular Blockade, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
Trial summary
The aim of this study is to estimate the optimal dose of sugammadex and neostigmine reversal of a vecuronium-induced residual neuromuscular block at train-of-four ratio 0.3. 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, Neostigmine and Saline 0.9%
- Type of treatment
- Injection or infusion
- How many people
- 121 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2018to 30 Jun 2019
- How long will I take part?
- 1 Day
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: people scheduled for elective surgery
Who may be able to join
- 1 age of 18 to 65 yr,
- 2 body mass index 18.5 to 25.0 kg/m2,
- 3 American Society of Anesthesiologists physical status I to III
- 4 scheduled for elective surgery with an expected duration of at least 60min under general anesthesia with intubation of the trachea or laryngeal mask
- 5 patients having given informed consent to the study
Who cannot join
- 1 patients who had participated in another clinical trial within 1 month
- 2 Patients with suspected difficult airway, bronchial asthma, chronic obstructive pulmonary disease
- 3 known neuromuscular disease
- 4 suspected malignant hyperthermia
- 5 hepatic or renal dysfunction
- 6 glaucoma
Show all 10Show fewer
- 7 allergy to the medication that used in this trial
- 8 taking medicaments that might influence the effect of NMB agents
- 9 pregnant, or breastfeeding state
- 10 taking medication known to alter the effect of neuromuscular blocking agents( toremifene .etc)
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Military Region General Hospital, Department of Anesthesiology
Guangzhou, Guangdong, 510010
About this study
Official title: Dose Finding Study for Reversal of Vecuronium-induced Neuromuscular Blockade at Train-of-four Ratio 0.3 With Sugammadex and Neostigmine
The aim of this study is to estimate the optimal dose of sugammadex and neostigmine reversal of a vecuronium-induced residual neuromuscular block at train-of-four ratio 0.3.
Read the detailed description
Sugammadex is a modified γ-cyclodextrin compound that reverses the neuromuscular blockade produced by steroidal nondepolarizing muscle relaxants such as rocuronium,vecuronium and pipecuronium by encapsulating them, making them unavailable to interact with the nicotinic acetylcholine receptors at the neuromuscular junction.However, residual neuromuscular blocks between reappearance of T4 and train-of-four ratio (TOFR)=0.5 are more frequent in clinical practice compared with profound or deep blocks and have not been investigated for sugammadex previously.
Unlike neostigmine, sugammadex is efficacious in reversing profound (no responses to either train-of-four (TOF) or posttetanic count stimulation) or deep (posttetanic count of 1 or 2) neuromuscular block (NMB) in doses of 16 and 4 mg/kg, respectively. However, shallow neuromuscular blocks are more frequent in clinical practice compared with profound or deep blocks and have not been investigated for sugammadex previously.
- Conditions
- Neuromuscular Blockade
- Being tested
- Sugammadex, Neostigmine, Saline 0.9%
- Keywords
- sugammadex neostigmine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Also called Bridion, Org 25969
At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of either :
Sugammadex 0.125 mg/kg (sugammadex 0.125) Sugammadex 0.25 mg/kg (sugammadex 0.25) Sugammadex 0.5 mg/kg (sugammadex 0.5) Sugammadex 1.0 mg/kg (sugammadex 1.0) Sugammadex 2.0 mg/kg (sugammadex 2.0)
NeostigmineDrug
Also called Prostigmin
At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of either :
Neostigmine 10 µg/kg (Neostigmine 10) Neostigmine 25 µg/kg (Neostigmine 25) Neostigmine 40 µg/kg (Neostigmine 40) Neostigmine 55 µg/kg (Neostigmine 55) Neostigmine 70 µg/kg (Neostigmine 70)
Atropine will be administered with Neostigmine at a half dose of Neostigmine administered through an intravenous line with brisk flow.
Saline 0.9%Drug
Also called Placebo
At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of saline 0.9%.
| Study group | Role | What they receive |
|---|---|---|
| sugammadex 0.125 | Sugammadex group: sugammadex 0.125 mg/kg IV once at the reappearance of TOF 0.3 Receives: Drug: Sugammadex | |
| Sugammadex 0.25 | Sugammadex group: sugammadex 0.25 mg/kg IV once at the reappearance of TOF 0.3 Receives: Drug: Sugammadex | |
| Sugammadex 0.5 | Sugammadex group: sugammadex 0.5 mg/kg IV once at the reappearance of TOF 0.3 Receives: Drug: Sugammadex | |
| Sugammadex 1.0 | Sugammadex group: sugammadex 1.0 mg/kg IV once at the reappearance of TOF 0.3 Receives: Drug: Sugammadex | |
| Sugammadex 2.0 | Sugammadex group: sugammadex 2.0 mg/kg IV once at the reappearance of TOF 0.3 Receives: Drug: Sugammadex | |
| Neostigmine 10 | Neostigmine group: neostigmine 10 µg/kg IV once at the reappearance of TOF 0.3 Receives: Drug: Neostigmine | |
| Neostigmine 25 | Neostigmine group: neostigmine 25 µg/kg IV once at the reappearance of TOF 0.3 Receives: Drug: Neostigmine | |
| Neostigmine 40 | Neostigmine group: neostigmine 40 µg/kg IV once at the reappearance of TOF 0.3 Receives: Drug: Neostigmine | |
| Neostigmine 55 | Neostigmine group: neostigmine 55 µg/kg IV once at the reappearance of TOF 0.3 Receives: Drug: Neostigmine | |
| Neostigmine 70 | Neostigmine group: neostigmine 70 µg/kg IV once at the reappearance of TOF 0.3 Receives: Drug: Neostigmine | |
| Placebo | Placebo group: Saline 0.9% IV once at the reappearance of TOF 0.3 Receives: Drug: Saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to TOF 0.9 after the administration of reversal agent
The time to achieve TOF (Train of Four stimulation) ratio to 0.9 following the investigational drug or placebo administration.
Measured: the general anesthesia time 1 hour at least
Secondary outcomes (2)
incidence of reparalysis
Determining whether patients receiving reversal agent will have a train-to-four ratio <0.8 during total recovery time (from TOF reach 0.9 first time to post-anaesthesia care unit (PACU) departure)
Measured: approximately 1 hour
incidence of adverse event
Documenting whether patients will have some adverse events(such as hypoxia bradycardia nausea and vomiting) from anesthesia commence to PACU departure.
Measured: the general anesthesia and recovery time 2 hours at least
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start26 Jul 2018
- Primary completion28 Jun 2019
- Study completion30 Jun 2019
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 Neuromuscular BlockadeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military Command
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bo xu, Guangzhou General Hospital of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656614
- Sponsor's protocol ID
- Reversal Neuromuscular Block
- Status last verified
- Aug 2020
- First submitted
- 10 Jul 2018
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Pongracz A, Szatmari S, Nemes R, Fulesdi B, Tassonyi E. Reversal of neuromuscular blockade with sugammadex at the reappearance of four twitches to train-of-four stimulation. Anesthesiology. 2013 Jul;119(1):36-42. doi: 10.1097/ALN.0b013e318297ce95.
PubMed 23665915Schaller SJ, Fink H, Ulm K, Blobner M. Sugammadex and neostigmine dose-finding study for reversal of shallow residual neuromuscular block. Anesthesiology. 2010 Nov;113(5):1054-60. doi: 10.1097/ALN.0b013e3181f4182a.
PubMed 20885293Kaufhold 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 26787792He J, He H, Li X, Sun M, Lai Z, Xu B. Required dose of sugammadex or neostigmine for reversal of vecuronium-induced shallow residual neuromuscular block at a train-of-four ratio of 0.3. Clin Transl Sci. 2022 Jan;15(1):234-243. doi: 10.1111/cts.13143. Epub 2021 Nov 2.
PubMed 34435439
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Finding Study for Reversal of Vecuronium-induced Neuromuscular Blockade at Train-of-four Ratio 0.3 With Sugammadex and Neostigmine
- ClinicalTrials.gov ID
- NCT03656614
- Acronym / sponsor ID
- Reversal Neuromuscular Block
- Conditions
- Neuromuscular Blockade
- Keywords
- sugammadex neostigmine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military CommandUniversity, hospital or other
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 4 Sep 2018 (actual)
- 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.
The aim of this study is to estimate the optimal dose of sugammadex and neostigmine reversal of a vecuronium-induced residual neuromuscular block at train-of-four ratio 0.3.
Detailed description
Sugammadex is a modified γ-cyclodextrin compound that reverses the neuromuscular blockade produced by steroidal nondepolarizing muscle relaxants such as rocuronium,vecuronium and pipecuronium by encapsulating them, making them unavailable to interact with the nicotinic acetylcholine receptors at the neuromuscular junction.However, residual neuromuscular blocks between reappearance of T4 and train-of-four ratio (TOFR)=0.5 are more frequent in clinical practice compared with profound or deep blocks and have not been investigated for sugammadex previously.
Unlike neostigmine, sugammadex is efficacious in reversing profound (no responses to either train-of-four (TOF) or posttetanic count stimulation) or deep (posttetanic count of 1 or 2) neuromuscular block (NMB) in doses of 16 and 4 mg/kg, respectively. However, shallow neuromuscular blocks are more frequent in clinical practice compared with profound or deep blocks and have not been investigated for sugammadex previously.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| sugammadex 0.125 | – | Drug: SugammadexSugammadex group: sugammadex 0.125 mg/kg IV once at the reappearance of TOF 0.3 |
| Sugammadex 0.25 | – | Drug: SugammadexSugammadex group: sugammadex 0.25 mg/kg IV once at the reappearance of TOF 0.3 |
| Sugammadex 0.5 | – | Drug: SugammadexSugammadex group: sugammadex 0.5 mg/kg IV once at the reappearance of TOF 0.3 |
| Sugammadex 1.0 | – | Drug: SugammadexSugammadex group: sugammadex 1.0 mg/kg IV once at the reappearance of TOF 0.3 |
| Sugammadex 2.0 | – | Drug: SugammadexSugammadex group: sugammadex 2.0 mg/kg IV once at the reappearance of TOF 0.3 |
| Neostigmine 10 | – | Drug: NeostigmineNeostigmine group: neostigmine 10 µg/kg IV once at the reappearance of TOF 0.3 |
| Neostigmine 25 | – | Drug: NeostigmineNeostigmine group: neostigmine 25 µg/kg IV once at the reappearance of TOF 0.3 |
| Neostigmine 40 | – | Drug: NeostigmineNeostigmine group: neostigmine 40 µg/kg IV once at the reappearance of TOF 0.3 |
| Neostigmine 55 | – | Drug: NeostigmineNeostigmine group: neostigmine 55 µg/kg IV once at the reappearance of TOF 0.3 |
| Neostigmine 70 | – | Drug: NeostigmineNeostigmine group: neostigmine 70 µg/kg IV once at the reappearance of TOF 0.3 |
| Placebo | – | Drug: Saline 0.9%Placebo group: Saline 0.9% IV once at the reappearance of TOF 0.3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- people scheduled for elective surgery
Key inclusion criteria (5 listed)
- 1 age of 18 to 65 yr,
- 2 body mass index 18.5 to 25.0 kg/m2,
- 3 American Society of Anesthesiologists physical status I to III
- 4 scheduled for elective surgery with an expected duration of at least 60min under general anesthesia with intubation of the trachea or laryngeal mask
- 5 patients having given informed consent to the study
Key exclusion criteria (10 listed)
- 1 patients who had participated in another clinical trial within 1 month
- 2 Patients with suspected difficult airway, bronchial asthma, chronic obstructive pulmonary disease
- 3 known neuromuscular disease
- 4 suspected malignant hyperthermia
- 5 hepatic or renal dysfunction
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: Bridion, Org 25969At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of either : Sugammadex 0.125 mg/kg (sugammadex 0.125) Sugammadex 0.25 mg/kg (sugammadex 0.25) Sugammadex 0.5 mg/kg (sugammadex 0.5) Sugammadex 1.0 mg/kg (sugammadex 1.0) Sugammadex 2.0 mg/kg (sugammadex 2.0) | Drug | Sugammadex 0.25, Sugammadex 0.5, Sugammadex 1.0, Sugammadex 2.0, sugammadex 0.125 |
| NeostigmineAlso: ProstigminAt the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of either : Neostigmine 10 µg/kg (Neostigmine 10) Neostigmine 25 µg/kg (Neostigmine 25) Neostigmine 40 µg/kg (Neostigmine 40) Neostigmine 55 µg/kg (Neostigmine 55) Neostigmine 70 µg/kg (Neostigmine 70) Atropine will be administered with Neostigmine at a half dose of Neostigmine administered through an intravenous line with brisk flow. | Drug | Neostigmine 10, Neostigmine 25, Neostigmine 40, Neostigmine 55, Neostigmine 70 |
| Saline 0.9%Also: PlaceboAt the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of saline 0.9%. | Drug | Placebo |
Primary outcome
Time to TOF 0.9 after the administration of reversal agent
Time frame: the general anesthesia time 1 hour at least
The time to achieve TOF (Train of Four stimulation) ratio to 0.9 following the investigational drug or placebo administration.
2 secondary outcomes
incidence of reparalysis
Time frame: approximately 1 hour
incidence of adverse event
Time frame: the general anesthesia and recovery time 2 hours at least
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 11 Aug 2020.
- Background: PubMed 23665915Pongracz A, Szatmari S, Nemes R, Fulesdi B, Tassonyi E. Reversal of neuromuscular blockade with sugammadex at the reappearance of four twitches to train-of-four stimulation. Anesthesiology. 2013 Jul;119(1):36-42. doi: 10.1097/ALN.0b013e318297ce95.
- Background: PubMed 20885293Schaller SJ, Fink H, Ulm K, Blobner M. Sugammadex and neostigmine dose-finding study for reversal of shallow residual neuromuscular block. Anesthesiology. 2010 Nov;113(5):1054-60. doi: 10.1097/ALN.0b013e3181f4182a.
- Background: 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.
- Derived from this study: PubMed 34435439He J, He H, Li X, Sun M, Lai Z, Xu B. Required dose of sugammadex or neostigmine for reversal of vecuronium-induced shallow residual neuromuscular block at a train-of-four ratio of 0.3. Clin Transl Sci. 2022 Jan;15(1):234-243. doi: 10.1111/cts.13143. Epub 2021 Nov 2.
Related trials for Neuromuscular Blockade
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
Not yet recruiting
Comparative Effects Of Exercises Targeting Upper Trapezius In Patients With Non Specific Neck Pain
Non Specific Neck Pain
RecruitingObservational study
The Association Between Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio
Muscle Relaxants
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neuromuscular Blockade, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
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 5 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 11 Aug 2020. 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 China. 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 0.9 after the administration of reversal agent (time frame: the general anesthesia time 1 hour at least). 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 NCT03656614, 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 11 Aug 2020.