Appropriate Dose of Neostigmine for Reversal of Rocuronium and Cisatracurium

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

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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