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Assessment Study of the Effect of NMBA on Bowel Peristalsis (CURARES)

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ClinicalTrials.gov Identifier: NCT02004015
Recruitment Status : Terminated
First Posted : December 6, 2013
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Tracking Information
First Submitted Date  ICMJE December 3, 2013
First Posted Date  ICMJE December 6, 2013
Last Update Posted Date February 13, 2017
Study Start Date  ICMJE November 2013
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
Proportion of patients with a score of motion = 0 [ Time Frame: 10 minutes after NMBA or placebo injection ]
Proportion of patients with a score of motion = 0
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02004015 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
Time at which thumb adductor twitch measurement disappears [ Time Frame: 1 month after injection ]
Time at which thumb adductor twitch measurement disappears (3rd consecutive measure with a twitch at 0). Mean minimal twitch measurement for those patients in who twitch measurement does not disappear. Concordance study between twitch measurement and bowel peristalsis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment Study of the Effect of NMBA on Bowel Peristalsis
Official Title  ICMJE Effect of an Induction Dose of Non Depolarizing Neuro Muscular Blocking Agents (NMBA) on Ultrasound Bowel Peristalsis.
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

Detailed Description

Primary End Point Proportion of patients with a score of motion = 0

Secondary End Point Time at which thumb adductor twitch measurement disappears (3rd consecutive measure with a twitch at 0) Mean minimal twitch measurement for those patients in who twitch measurement does not disappear Concordance study between twitch measurement and bowel peristalsis XML File Identifier: 1vUwHz2uUXeSc7soLu1cQwRAfcM= Page 15/24 ultrasound score.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Physiopathology
Intervention  ICMJE
  • Drug: injection of placebo
    0.5 mg/kg milligram(s)/kilogram
  • Drug: injection of NMBA
Study Arms  ICMJE
  • Experimental: Atracurium
    injection of NMBA 0.5 mg/kg milligram(s)/kilogram in Intravenous bolus use
    Intervention: Drug: injection of NMBA
  • Experimental: ROCURONIUM
    injection of NMBA 0.6 mg/kg milligram(s)/kilogram in Intravenous bolus
    Intervention: Drug: injection of NMBA
  • Placebo Comparator: placebo
    injection of placebo Injection in Intravenous bolus use
    Intervention: Drug: injection of placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 11, 2015)
50
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2013)
100
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • elective surgery
  • scheduled oro tracheal intubation

Exclusion Criteria:

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02004015
Other Study ID Numbers  ICMJE RBM_WTR_2012-9
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fondation Ophtalmologique Adolphe de Rothschild
Study Sponsor  ICMJE Fondation Ophtalmologique Adolphe de Rothschild
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guillaume Taylor Fondation Ophtalmologique Adolphe de Rothschild
PRS Account Fondation Ophtalmologique Adolphe de Rothschild
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP