Appropriate Dose of Neostigmine for Reversal of Rocuronium and Cisatracurium

NCT01885715 | Completed

• 2 other identifiers: B-1208/168-009Eunsu Choi
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Observation of Neuromuscular Block

Outcome Measures

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 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

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

Study Arms (8)

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

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.

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

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

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

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

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

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

Drug: Injection of neostigmine

Interventions

Injection of neostigmine DRUG

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.

Cisatracurium-neostigmine 10 ㎍; Cisatracurium-neostigmine 20 ㎍; Cisatracurium-neostigmine 40 ㎍; Cisatracurium-placebo; Rocuronium-neostigmine 10 ㎍; Rocuronium-neostigmine 20 ㎍; Rocuronium-neostigmine 40 ㎍; Rocuronium-placebo

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Eunsu Choi

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Study Officials

• Ah Young Oh

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: June 25, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 13, 2014

Record last verified: 2014-06

Locations

KR (1)