NCT02004015

Brief Summary

Phase III prospective randomised study : curare vs placebo, comparing bowel peristalsis (abdominal echography) in the first minutes of after general anesthesia induction. Primary End Point: proportion of patients with a score of motion = 0

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

February 13, 2017

Status Verified

March 1, 2015

Enrollment Period

1.4 years

First QC Date

December 3, 2013

Last Update Submit

February 10, 2017

Conditions

Physiopathology

Keywords

AnalyticalDiagnosticAnesthesiaAnalgesia

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with a score of motion = 0

    Proportion of patients with a score of motion = 0

    10 minutes after NMBA or placebo injection

Secondary Outcomes (1)

  • Time at which thumb adductor twitch measurement disappears

    1 month after injection

Study Arms (3)

Atracurium

EXPERIMENTAL

injection of NMBA 0.5 mg/kg milligram(s)/kilogram in Intravenous bolus use

Drug: injection of NMBA

ROCURONIUM

EXPERIMENTAL

injection of NMBA 0.6 mg/kg milligram(s)/kilogram in Intravenous bolus

Drug: injection of NMBA

placebo

PLACEBO COMPARATOR

injection of placebo Injection in Intravenous bolus use

Drug: injection of placebo

Interventions

injection of placeboDRUG

0.5 mg/kg milligram(s)/kilogram

placebo
injection of NMBADRUG
AtracuriumROCURONIUM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective surgery
  • scheduled oro tracheal intubation

You may not qualify if:

  • Counter indication to NMBA:
  • predicted difficult airway
  • surgical counter indication: facial or laryngeal nerve function monitoring
  • allergy to muscle relaxants neuro muscular disease Possible alteration of sensitivity to muscle relaxants due to ongoing medication: ex Valproate or aminoglycoside antibiotics. Predictable alteration of bowel movements or difficult abdominal ultrasound:
  • scheduled abdominal surgery
  • abdominal surgery in last month
  • obesity: body mass index over 30 Full stomach or pregnancy requiring suxamethonium for intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

DiseaseAgnosia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Officials

  • Guillaume Taylor

    Fondation Ophtalmologique Adolphe de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2013

First Posted

December 6, 2013

Study Start

November 1, 2013

Primary Completion

April 1, 2015

Last Updated

February 13, 2017

Record last verified: 2015-03

Locations

FR(1)