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Appropriate Dose of Neostigmine for Reversal of Rocuronium and Cisatracurium

Appropriate Dose of Neostigmine for Reversal of Rocuronium and Cisatracurium

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01885715
Enrollment
112
Registered
2013-06-25
Start date
2013-06-30
Completion date
2014-06-30
Last updated
2014-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Observation of Neuromuscular Block

Brief 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.

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.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 69 Years
Healthy volunteers
No

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frameDescription
time to reverse from light muscle relaxationtime from TOF 0.5 to TOF 1.0 after injection of different doses of neostigminePrimary 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

Secondary

MeasureTime frameDescription
time to reverse from TOF ratio 0.5 to 0.9time from TOF 0.5 to TOF 0.9 after injection of different doses of neostigmineSecondary 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026