Appropriate Dose of Neostigmine for Reversal of Rocuronium and Cisatracurium

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Seoul National University

Status

Completed

Conditions

Observation of Neuromuscular Block

Treatments

Drug: Injection of neostigmine

Study type

Interventional

Funder types

Other

Identifiers

NCT01885715
Eunsu Choi (Registry Identifier)
B-1208/168-009

Details and patient eligibility

About

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.

Enrollment

112 patients

Sex

All

Ages

19 to 69 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

112 participants in 8 patient groups, including a placebo group

Rocuronium-placebo
Placebo Comparator group
Description:
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
Treatment:
Drug: Injection of neostigmine
Rocuronium-neostigmine 10 ㎍
Active Comparator group
Description:
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.
Treatment:
Drug: Injection of neostigmine
Rocuronium-neostigmine 20 ㎍
Active Comparator group
Description:
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
Treatment:
Drug: Injection of neostigmine
Rocuronium-neostigmine 40 ㎍
Active Comparator group
Description:
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
Treatment:
Drug: Injection of neostigmine
Cisatracurium-placebo
Placebo Comparator group
Description:
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
Treatment:
Drug: Injection of neostigmine
Cisatracurium-neostigmine 10 ㎍
Active Comparator group
Description:
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
Treatment:
Drug: Injection of neostigmine
Cisatracurium-neostigmine 20 ㎍
Active Comparator group
Description:
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
Treatment:
Drug: Injection of neostigmine
Cisatracurium-neostigmine 40 ㎍
Active Comparator group
Description:
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
Treatment:
Drug: Injection of neostigmine

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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