Appropriate Dose of Neostigmine for Reversal of Rocuronium and Cisatracurium
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
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.
|
| 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
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.
|
| 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
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.
|
| 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
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.
|
| 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
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.
|
| 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
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.
|
| 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
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.
|
| 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
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.
|
Outcome Measures
Primary Outcome Measures
- time to reverse from light muscle relaxation [time from TOF 0.5 to TOF 1.0 after injection of different doses of neostigmine]
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
Secondary Outcome Measures
- 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]
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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Eunsu Choi | Seongnam-si | Gyeonggi-do | Korea, Republic of | 463-707 |
Sponsors and Collaborators
- Seoul National University Hospital
Investigators
- Principal Investigator: Ah Young Oh, Professor
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B-1208/168-009
- Eunsu Choi