NCT01809886

Brief Summary

The purpose of this clinical trial is to prove that the administration of sugammadex at a dose of 4 mg/kg for counteracting deep blockage \[without train-of-four (TOF) ratio response and post-tetanic count (PTC) \< of 2 induced and maintained with Rocuronium in pediatric patients for short-term elective surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2011

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2012

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 6, 2014

Status Verified

March 1, 2014

Enrollment Period

2 years

First QC Date

August 28, 2012

Last Update Submit

March 5, 2014

Conditions

Neuromuscular Blockade

Keywords

Neuromuscular relaxantsshort-term pediatric surgeryreverses neuromuscular blockade

Outcome Measures

Primary Outcomes (1)

  • The time in seconds which has elapsed until a T4/T1 ratio >0,9.

    After surgery (Up to 10 h)

Secondary Outcomes (8)

  • Heart Rate (beats / min)

    After surgery (Up to 10 h)

  • Systolic and Diastolic blood pressure (mm HG)

    After surgery (up to 10 h)

  • Arterial oxygen saturation (%)

    After surgery (up to 10 h)

  • Total dose of rocuronium (mg/kg)

    After surgery (up to 10 h)

  • Number of participants with at least One Adverse event (AE)

    up to 24 h

  • +3 more secondary outcomes

Study Arms (2)

Sugammadex

EXPERIMENTAL

50 patients, aged between 2 and 11 years scheduled for surgery and requiring muscle relaxation. The reversal will be made with sugammadex 4 mg/kg when surgery is over, maintaining a profound block level until that point in time (no response to TOF and PTC\<2).

Drug: Sugammadex

Neostigmina

ACTIVE COMPARATOR

50 patients aged between 2 and 11 years scheduled for surgery and requiring muscle relaxation. The reversal will be made with neostigmine 0. 05 mg/kg and atropine 0.025 mg/kg (conventional reverser treatment) when surgery is over, maintaining a profound block level unit that point in time (no response to TOF and PTC\<2).

Drug: Neostigmine

Interventions

SugammadexDRUG

50 patients, aged between 2 and 11 years scheduled for surgery and requiring muscle relaxation. The reversal will be made with sugammadex 4 mg/kg when surgery is over, maintaining a profound block level until that point in time (no response to TOF and PTC\<2).

Sugammadex
NeostigmineDRUG

50 patients aged between 2 and 11 years scheduled for surgery and requiring muscle relaxation. The reversal will be made with neostigmine 0. 05 mg/kg and atropine 0.025 mg/kg (conventional reverser treatment) when surgery is over, maintaining a profound block level unit that point in time (no response to TOF and PTC\<2).

Neostigmina

Eligibility Criteria

Age2 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children of both sexes,
  • Aged between two and eleven years who have undergone surgery for procedures of short duration (less than one hour) and requiring muscle relaxation.
  • Informed consent signed by parents or guardians

You may not qualify if:

  • No signed informed consent by parent/guardian,
  • Anticipated difficult airway,
  • Neuromuscular disease,
  • Liver and/or renal failure,
  • Personal or family history of malignant hyperthermia,
  • Previous allergic reaction to any anesthetic.
  • Treated at the time of the study with aminoglycosides, magnesium, or anticonvulsants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mª Dolores Cárceles Barón

El Palmar, Murcia, 30120, Spain

Location

MeSH Terms

Interventions

SugammadexNeostigmine

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydratesPhenylammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

Study Officials

  • MºDolores Cárceles Barón, MD,PhD

    Hospital Universitario Virgen de la Arrixaca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2012

First Posted

March 13, 2013

Study Start

October 1, 2011

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

March 6, 2014

Record last verified: 2014-03

Locations

ES(1)