Appropriate Dose of Neostigmine for Reversal of Rocuronium and Cisatracurium

Observation of Neuromuscular Block Clinical Trial

Official title:

Appropriate Dose of Neostigmine for Reversal of Rocuronium and Cisatracurium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885715
• Other study ID #: B-1208/168-009
• Secondary ID: Eunsu Choi
• Status: Completed
• Phase: N/A
• First received: June 14, 2013
• Last updated: June 12, 2014
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Observation of Neuromuscular Block

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Eunsu Choi	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	time to reverse from TOF ratio 0.5 to 0.9	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	time from TOF 0.5 to TOF 0.9 after injection of different doses of neostigmine	No