CClinicalTrials.gg
CompletedNCT01885715Updated Jun 13, 2014

Appropriate Dose of Neostigmine for Reversal of Rocuronium and Cisatracurium

An interventional study of Injection of neostigmine in Observation of Neuromuscular Block, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 69 Years. Per ClinicalTrials.gov, last updated 2014-06-13.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
19 Years to 69 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Observation of Neuromuscular Block
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • American Society of Anesthesiologist Physical status classification 1 or 2 elective surgery under general anesthesia

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
112 participants (actual)

Study arms

  • Placebo comparator
    Rocuronium-placebo

    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

    Drug: Injection of neostigmine

  • Active comparator
    Rocuronium-neostigmine 10 ㎍

    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.

    Drug: Injection of neostigmine

  • Active comparator
    Rocuronium-neostigmine 20 ㎍

    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

    Drug: Injection of neostigmine

  • Active comparator
    Rocuronium-neostigmine 40 ㎍

    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

    Drug: Injection of neostigmine

  • Placebo comparator
    Cisatracurium-placebo

    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

    Drug: Injection of neostigmine

  • Active comparator
    Cisatracurium-neostigmine 10 ㎍

    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

    Drug: Injection of neostigmine

  • Active comparator
    Cisatracurium-neostigmine 20 ㎍

    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

    Drug: Injection of neostigmine

  • Active comparator
    Cisatracurium-neostigmine 40 ㎍

    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

    Drug: Injection of neostigmine

Interventions

  • DrugInjection of neostigmine

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: time from TOF 0.5 to TOF 0.9 after injection of different doses of neostigmine

07

Study locations

1 site
  • Eunsu Choi
    Seongnam-si, Gyeonggi-do 463-707, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01885715
Lead sponsor
Seoul National University Hospital
Responsible party
Sponsor
First posted
Jun 25, 2013
Start date
Jun 2013
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Jun 13, 2014

Study contacts

Ah Young Oh
principal investigator · Professor

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion