NCT02330172

Brief Summary

This study aims to make a comparison of surgical condition and recovery time between rocuronium 0.45 mg/kg and neostigmine group and rocuronium 0.9 mg/kg and sugammadex group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

April 17, 2017

Completed
Last Updated

April 17, 2017

Status Verified

July 1, 2015

Enrollment Period

1.3 years

First QC Date

December 9, 2014

Results QC Date

December 15, 2016

Last Update Submit

March 2, 2017

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

  • Laryngoscopic Score

    Definitions for evaluation of Laryngoscopycondition. : Easy = jaw relaxed, no resistance to blade insertion, fair = jaw not fully relaxed, slight resistance to blade insertion, difficult = poor jaw relaxation, active resistance of the patient to laryngoscopy. Variables Excellent Good Poor

    At the beginning of surgery, the surgeon rated the laryngoscopy condition

Secondary Outcomes (1)

  • Recovery Time From Neuromuscular Blockade

    from the injection of neostigmine or sugammadex up to 30 minutes

Study Arms (2)

rocuronium 0.45 - neostigmine

ACTIVE COMPARATOR

when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation. When the end of operation, a injection of neostigmine or sugammadex will be administered.

Other: Injection of neostigmine or sugammadex

rocuronium 0.9 - sugammadex

ACTIVE COMPARATOR

When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation. When the end of operation,, a injection of neostigmine or sugammadex be administered.

Other: Injection of neostigmine or sugammadex

Interventions

Injection of neostigmine or sugammadexOTHER

At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation. During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected.

Also known as: neostigmin or sugammadex
rocuronium 0.45 - neostigminerocuronium 0.9 - sugammadex

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologist Physical status classification 1 or 2 elective laryngeal microsurgery 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eunsu Choi

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

Location

Related Publications (1)

  • Choi ES, Oh AY, Koo BW, Hwang JW, Han JW, Seo KS, Ahn SH, Jeong WJ. Comparison of reversal with neostigmine of low-dose rocuronium vs. reversal with sugammadex of high-dose rocuronium for a short procedure. Anaesthesia. 2017 Oct;72(10):1185-1190. doi: 10.1111/anae.13894. Epub 2017 May 11.

    PMID: 28493510DERIVED

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Results Point of Contact

Title
Eunsu Choi
Organization
Seoul national university Bundang Hospital
potterydoll@hanmail.net
821032990658

Study Officials

  • Ah Young Oh

    Bungdang Seoul National University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

December 9, 2014

First Posted

January 1, 2015

Study Start

May 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

April 17, 2017

Results First Posted

April 17, 2017

Record last verified: 2015-07

Locations

KR(1)