Neuromuscular Block, ResidualNCT03292965
Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery
A study testing Neostigmine and Sugammadex in people with Neuromuscular Block, Residual, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Compare the reversal effect of neostigmine and sugammadex using quantitative neuromuscular monitoring Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Block, Residual
- What is being tested?
- Neostigmine and Sugammadex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Sep 2017to 29 Nov 2017
- 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
- patients aged over 18 years, planned to undergoing elective laparoscopic surgery under general anesthesia
Who cannot join
- Obesity BMI over 30 kg/m2
- Impairment of renal or/and liver function
- Allergy to rocuronium, sugammadex
- (Familial) history of malignant hyperthermia
- Taking medicines which is affecting neuromuscular function
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery: Comparison of Neostigmine and Sugammadex
Compare the reversal effect of neostigmine and sugammadex using quantitative neuromuscular monitoring
Read the detailed description
At the end of surgery, decide the dosage of reversal referring to quantitative neuromuscular monitoring value (TOF). After the administration of reversal, the anesthesiologist who are going to manage the participant should not check the quantitative neuromuscular monitoring and determine the timing of extubation only with his (or her) judgement. After entering post-anaesthesia care unit (PACU) measure the TOF value and check the incidence of TOF ratio > 0.9 between the neostigmine group and sugammadex group.
- Conditions
- Neuromuscular Block, Residual
- Being tested
- Neostigmine, Sugammadex
- 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.
NeostigmineDrug
Referring to the randomisation allocation program, participants allocated to group neostigmine, administrate neostigmine as reversal
SugammadexDrug
Also called Bridion
Referring to the randomisation allocation program, participants allocated to group sugammadex, administrate sugammadex as reversal
| Study group | Role | What they receive |
|---|---|---|
| Neostigmine | Active comparator | At the end of surgery, administrating neostigmine to participants according to the protocol below:
when train-of-four (TOF) 2-3, administrating neostigmine 50mcg/kg when TOF 4 with fade, administrating neostigmine 40mcg/kg when TOF 4 without fade, administrating neostigmine 20mcg/kg Receives: Drug: Neostigmine |
| Sugammadex | Active comparator | At the end of surgery, administrating sugammadex to participants according to the protocol below:
when TOF=0 and post-tetanic count (PTC)=1 or more, administrating sugammadex 4mg/kg when TOF=1 or more, administrating sugammadex 2mg/kg when TOF 4 without fade, administrating neostigmine 20mcg/kg Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of postoperative residual curarization
definition of postoperative residual curarization: TOF ration is 0.9 or over 0.9
Measured: Immediately after entering PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start28 Sep 2017
- Primary completion29 Nov 2017
- Study completion29 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular Block, ResidualStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEE YEA JI, Seoul National University Bundang Hospital
- Investigators
- AhYoung Oh, M.D Ph. D, Study chair, Department of anesthesiology and pain medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292965
- Sponsor's protocol ID
- B-1609-363-002
- Status last verified
- Oct 2018
- First submitted
- 21 Sep 2017
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee YJ, Oh AY, Koo BW, Han JW, Park JH, Hong JP, Seo KS. Postoperative residual neuromuscular blockade after reversal based on a qualitative peripheral nerve stimulator response: A randomised controlled trial. Eur J Anaesthesiol. 2020 Mar;37(3):196-202. doi: 10.1097/EJA.0000000000001157.
PubMed 31977627
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery: Comparison of Neostigmine and Sugammadex
- ClinicalTrials.gov ID
- NCT03292965
- Acronym / sponsor ID
- B-1609-363-002
- Conditions
- Neuromuscular Block, Residual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 26 Sep 2017 (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.
Compare the reversal effect of neostigmine and sugammadex using quantitative neuromuscular monitoring
Detailed description
At the end of surgery, decide the dosage of reversal referring to quantitative neuromuscular monitoring value (TOF). After the administration of reversal, the anesthesiologist who are going to manage the participant should not check the quantitative neuromuscular monitoring and determine the timing of extubation only with his (or her) judgement. After entering post-anaesthesia care unit (PACU) measure the TOF value and check the incidence of TOF ratio > 0.9 between the neostigmine group and sugammadex group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neostigmine | Active comparator | Drug: NeostigmineAt the end of surgery, administrating neostigmine to participants according to the protocol below: when train-of-four (TOF) 2-3, administrating neostigmine 50mcg/kg when TOF 4 with fade, administrating neostigmine 40mcg/kg when TOF 4 without fade, administrating neostigmine 20mcg/kg |
| Sugammadex | Active comparator | Drug: SugammadexAt the end of surgery, administrating sugammadex to participants according to the protocol below: when TOF=0 and post-tetanic count (PTC)=1 or more, administrating sugammadex 4mg/kg when TOF=1 or more, administrating sugammadex 2mg/kg when TOF 4 without fade, administrating neostigmine 20mcg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients aged over 18 years, planned to undergoing elective laparoscopic surgery under general anesthesia
Key exclusion criteria (5 listed)
- Obesity BMI over 30 kg/m2
- Impairment of renal or/and liver function
- Allergy to rocuronium, sugammadex
- (Familial) history of malignant hyperthermia
- Taking medicines which is affecting neuromuscular function
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 |
|---|---|---|
| NeostigmineReferring to the randomisation allocation program, participants allocated to group neostigmine, administrate neostigmine as reversal | Drug | Neostigmine |
| SugammadexAlso: BridionReferring to the randomisation allocation program, participants allocated to group sugammadex, administrate sugammadex as reversal | Drug | Sugammadex |
Primary outcome
the incidence of postoperative residual curarization
Time frame: Immediately after entering PACU
definition of postoperative residual curarization: TOF ration is 0.9 or over 0.9
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 9 Oct 2018.
- Derived from this study: PubMed 31977627Lee YJ, Oh AY, Koo BW, Han JW, Park JH, Hong JP, Seo KS. Postoperative residual neuromuscular blockade after reversal based on a qualitative peripheral nerve stimulator response: A randomised controlled trial. Eur J Anaesthesiol. 2020 Mar;37(3):196-202. doi: 10.1097/EJA.0000000000001157.
- 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.
AhYoung Oh, M.D Ph. D study chair
Department of anesthesiology and pain medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neostigmine and Sugammadex in people with Neuromuscular Block, Residual, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 1 inclusion and 5 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 9 Oct 2018. 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 South Korea. 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?
the incidence of postoperative residual curarization (time frame: Immediately after entering PACU). 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 NCT03292965, which also lists 1 linked publication.
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 9 Oct 2018; AzTrials last refreshed its copy on 8 Nov 2026.