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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

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


Condition or disease Intervention/treatment Phase
Physiopathology Drug: injection of placebo Drug: injection of NMBA Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of an Induction Dose of Non Depolarizing Neuro Muscular Blocking Agents (NMBA) on Ultrasound Bowel Peristalsis.
Study Start Date : November 2013
Actual Primary Completion Date : April 2015

Arm Intervention/treatment
Experimental: Atracurium
injection of NMBA 0.5 mg/kg milligram(s)/kilogram in Intravenous bolus use
Drug: injection of NMBA
Experimental: ROCURONIUM
injection of NMBA 0.6 mg/kg milligram(s)/kilogram in Intravenous bolus
Drug: injection of NMBA
Placebo Comparator: placebo
injection of placebo Injection in Intravenous bolus use
Drug: injection of placebo
0.5 mg/kg milligram(s)/kilogram




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004015


Locations
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France
Fondation Ophtalmologique Adolphe de Rothschild
Paris, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Principal Investigator: Guillaume Taylor Fondation Ophtalmologique Adolphe de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02004015     History of Changes
Other Study ID Numbers: RBM_WTR_2012-9
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: March 2015

Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Analytical
Diagnostic
Anesthesia
Analgesia

Additional relevant MeSH terms:
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Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs