Observation of Neuromuscular BlockNCT01885715
Appropriate Dose of Neostigmine for Reversal of Rocuronium and Cisatracurium
A study testing Injection of neostigmine in people with Observation of Neuromuscular Block, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to find appropriate dose of neostigmine which is possible to reverse rocuronium or cisatracurium till train of four (TOF) 0.9 within 10 minutes. Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Observation of Neuromuscular Block
- What is being tested?
- Injection of neostigmine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Jun 2014
- 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 19 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist Physical status classification 1 or 2 elective surgery under general anesthesia
Who cannot join
- BMI >25 or < 20 kg/m2
- Patients taking intercurrent medication
- Glutamic Oxalacetate Transaminase or Glutamic Pyruvate Transaminase > 40 IU/L, Cr > 1.4 mg/dl
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to find appropriate dose of neostigmine which is possible to reverse rocuronium or cisatracurium till train of four (TOF) 0.9 within 10 minutes.
- Conditions
- Observation of Neuromuscular Block
- Being tested
- Injection of neostigmine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of neostigmineDrug
At induction, we will inject rocuronium 0.6 mg/kg for rocuronium arms and cisatracurium 0.15 mg/kg for cisatracurium arms.
During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, normal saline 5 ml will be injected in placebo arms. And neostigmine 10, 20, or 40 ㎍/kg will injected in each arms.
| Study group | Role | What they receive |
|---|---|---|
| Rocuronium-placebo | Placebo comparator | At anesthetic induction, rocuronium 0.6 mg/kg will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. When TOF ratio recover to 0.5, normal saline 5 ml will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0 Receives: Drug: Injection of neostigmine |
| Rocuronium-neostigmine 10 ㎍ | Active comparator | At anesthetic induction, rocuronium 0.6 mg/kg will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, neostigmine 10 ㎍/kg will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0. Receives: Drug: Injection of neostigmine |
| Rocuronium-neostigmine 20 ㎍ | Active comparator | At anesthetic induction, rocuronium 0.6 mg/kg will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, neostigmine 20 ㎍/kg will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0 Receives: Drug: Injection of neostigmine |
| Rocuronium-neostigmine 40 ㎍ | Active comparator | At anesthetic induction, rocuronium 0.6 mg/kg will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, neostigmine 40 ㎍/kg will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0 Receives: Drug: Injection of neostigmine |
| Cisatracurium-placebo | Placebo comparator | At anesthetic induction, cisatracurium 0.15 mg/kg will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, normal saline 5 ml will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0 Receives: Drug: Injection of neostigmine |
| Cisatracurium-neostigmine 10 ㎍ | Active comparator | At anesthetic induction, cisatracurium 0.15 mg/kg will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, neostigmine 10 ㎍/kg will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0 Receives: Drug: Injection of neostigmine |
| Cisatracurium-neostigmine 20 ㎍ | Active comparator | At anesthetic induction, cisatracurium 0.15 mg/kg will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, neostigmine 20 ㎍/kg will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0 Receives: Drug: Injection of neostigmine |
| Cisatracurium-neostigmine 40 ㎍ | Active comparator | At anesthetic induction, cisatracurium 0.15 mg/kg will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, neostigmine 40 ㎍/kg will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0 Receives: Drug: Injection of neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to reverse from light muscle relaxation
Primary outcome of this study is how long it takes time to reverse from TOF ratio 0.5 to 1.0 after injection of different doses of neostigmine at the TOF 0.5
Measured: time from TOF 0.5 to TOF 1.0 after injection of different doses of neostigmine
Secondary outcomes (1)
time to reverse from TOF ratio 0.5 to 0.9
Secondary outcome of this study is how long it takes time to reverse from TOF ratio 0.5 to 0.9 after injection of different doses of neostigmine at the TOF 0.5
Measured: time from TOF 0.5 to TOF 0.9 after injection of different doses of neostigmine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Observation of Neuromuscular BlockStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ah Young Oh, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885715
- Sponsor's protocol ID
- B-1208/168-009
- Other IDs
- Eunsu Choi
- Status last verified
- Jun 2014
- First submitted
- 14 Jun 2013
- Last updated
- 13 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriate Dose of Neostigmine for Reversal of Rocuronium and Cisatracurium
- ClinicalTrials.gov ID
- NCT01885715
- Acronym / sponsor ID
- B-1208/168-009
- Conditions
- Observation of Neuromuscular Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 Jun 2013 (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 aims to find appropriate dose of neostigmine which is possible to reverse rocuronium or cisatracurium till train of four (TOF) 0.9 within 10 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Rocuronium-placebo | Placebo comparator | Drug: Injection of neostigmineAt anesthetic induction, rocuronium 0.6 mg/kg will be injected for muscle relaxation. During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. When TOF ratio recover to 0.5, normal saline 5 ml will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0 |
| Rocuronium-neostigmine 10 ㎍ | Active comparator | Drug: Injection of neostigmineAt anesthetic induction, rocuronium 0.6 mg/kg will be injected for muscle relaxation. During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, neostigmine 10 ㎍/kg will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0. |
| Rocuronium-neostigmine 20 ㎍ | Active comparator | Drug: Injection of neostigmineAt anesthetic induction, rocuronium 0.6 mg/kg will be injected for muscle relaxation. During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, neostigmine 20 ㎍/kg will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0 |
| Rocuronium-neostigmine 40 ㎍ | Active comparator | Drug: Injection of neostigmineAt anesthetic induction, rocuronium 0.6 mg/kg will be injected for muscle relaxation. During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, neostigmine 40 ㎍/kg will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0 |
| Cisatracurium-placebo | Placebo comparator | Drug: Injection of neostigmineAt anesthetic induction, cisatracurium 0.15 mg/kg will be injected for muscle relaxation. During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, normal saline 5 ml will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0 |
| Cisatracurium-neostigmine 10 ㎍ | Active comparator | Drug: Injection of neostigmineAt anesthetic induction, cisatracurium 0.15 mg/kg will be injected for muscle relaxation. During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, neostigmine 10 ㎍/kg will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0 |
| Cisatracurium-neostigmine 20 ㎍ | Active comparator | Drug: Injection of neostigmineAt anesthetic induction, cisatracurium 0.15 mg/kg will be injected for muscle relaxation. During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, neostigmine 20 ㎍/kg will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0 |
| Cisatracurium-neostigmine 40 ㎍ | Active comparator | Drug: Injection of neostigmineAt anesthetic induction, cisatracurium 0.15 mg/kg will be injected for muscle relaxation. During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, neostigmine 40 ㎍/kg will be injected. And we will measure time to take from TOF ratio 0.5 to 1.0 |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologist Physical status classification 1 or 2 elective surgery under general anesthesia
Key exclusion criteria (3 listed)
- BMI >25 or < 20 kg/m2
- Patients taking intercurrent medication
- Glutamic Oxalacetate Transaminase or Glutamic Pyruvate Transaminase > 40 IU/L, Cr > 1.4 mg/dl
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 |
|---|---|---|
| Injection of neostigmineAt induction, we will inject rocuronium 0.6 mg/kg for rocuronium arms and cisatracurium 0.15 mg/kg for cisatracurium arms. During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, normal saline 5 ml will be injected in placebo arms. And neostigmine 10, 20, or 40 ㎍/kg will injected in each arms. | Drug | Cisatracurium-neostigmine 10 ㎍, Cisatracurium-neostigmine 20 ㎍, Cisatracurium-neostigmine 40 ㎍, Cisatracurium-placebo, Rocuronium-neostigmine 10 ㎍, Rocuronium-neostigmine 20 ㎍, Rocuronium-neostigmine 40 ㎍, Rocuronium-placebo |
Primary outcome
time to reverse from light muscle relaxation
Time frame: time from TOF 0.5 to TOF 1.0 after injection of different doses of neostigmine
Primary outcome of this study is how long it takes time to reverse from TOF ratio 0.5 to 1.0 after injection of different doses of neostigmine at the TOF 0.5
1 secondary outcome
time to reverse from TOF ratio 0.5 to 0.9
Time frame: time from TOF 0.5 to TOF 0.9 after injection of different doses of neostigmine
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 13 Jun 2014.
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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.
Ah Young Oh principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of neostigmine in people with Observation of Neuromuscular Block, run by Seoul National University 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 3 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 13 Jun 2014. 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. Some participants in this study may receive a placebo. 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 reverse from light muscle relaxation (time frame: time from TOF 0.5 to TOF 1.0 after injection of different doses of neostigmine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2014.