NCT01890057

Brief Summary

To find out the dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound rocuronium-induced neuromuscular block in young and elderly adult patients.

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 Jun 2013

Shorter than P25 for not_applicable

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

June 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 4, 2014

Status Verified

February 1, 2014

Enrollment Period

7 months

First QC Date

June 26, 2013

Last Update Submit

February 2, 2014

Conditions

Anesthesia Recovery Period, Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

  • The dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound neuromuscular block

    2 hour

Study Arms (2)

Young adults

EXPERIMENTAL

To find out the the dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound neuromuscular block : Dixon's up-and-down method

Drug: Sugammadex

Elderly adults

EXPERIMENTAL

To find out the the dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound neuromuscular block : Dixon's up-and-down method

Drug: Sugammadex

Interventions

SugammadexDRUG

The dose of sugammadex

Elderly adultsYoung adults

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or ≥70 years ASA class I-II patients who received surgery less than 2 hours.

You may not qualify if:

  • anticipated difficult intubation
  • neuromuscular, hepatic or renal disorders
  • drug allergy
  • body mass index \>30 kg/m2 or body mass index \<18 kg/m2
  • emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 26, 2013

First Posted

July 1, 2013

Study Start

June 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

February 4, 2014

Record last verified: 2014-02

Locations

KR(1)