Appropriate Dose of Neostigmine for Reversal of Rocuronium and Cisatracurium

Not Applicable

Completed

• Conditions: Observation of Neuromuscular Block
• Interventions: Drug: Injection of neostigmine

• Registration Number: NCT01885715
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-14
• Study First Submitted QC: 2013-06-24
• Study First Posted: 2013-06-25
• Status Verified: 2014-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-06-12
• Last Update Posted: 2014-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rocuronium-placebo	Injection of neostigmine	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
Cisatracurium-neostigmine 10 ㎍	Injection of neostigmine	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
Rocuronium-neostigmine 10 ㎍	Injection of neostigmine	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.
Rocuronium-neostigmine 20 ㎍	Injection of neostigmine	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
Cisatracurium-placebo	Injection of neostigmine	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
Rocuronium-neostigmine 40 ㎍	Injection of neostigmine	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
Cisatracurium-neostigmine 20 ㎍	Injection of neostigmine	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
Cisatracurium-neostigmine 40 ㎍	Injection of neostigmine	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Eunsu Choi; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of