NCT02708056

Brief Summary

The objective of this study is to evaluate the efficacy and safety of sugammadex in reversing profound neuromuscular block induced by rocuronium in infant patients

Trial Health

100
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_4

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

January 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

1.1 years

First QC Date

February 25, 2016

Last Update Submit

March 9, 2016

Conditions

Brain Cancer

Keywords

SugammadexRocuroniumInfant patients

Outcome Measures

Primary Outcomes (1)

  • The efficacy of sugammadex were assessed by using Train of four (TOF)

    1 year

Study Arms (1)

Sugammadex, Bridion

OTHER

Drug were given intravenously by a anesthesiologist at the end of surgery

Drug: Sugammadex

Interventions

SugammadexDRUG
Also known as: Bridion
Sugammadex, Bridion

Eligibility Criteria

Age1 Month - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients between the ages of 1-12 month,
  • ASA physical status 1-3 who underwent elective brain cancer surgery during general anesthesia were included in the study

You may not qualify if:

  • younger than 1month or older than 12 months.
  • hepatic or renal failure
  • A history of allergy to study medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Sugammadex

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 25, 2016

First Posted

March 15, 2016

Study Start

January 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 15, 2016

Record last verified: 2016-03