Assessment Study of the Effect of NMBA on Bowel Peristalsis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of an Induction Dose of Non Depolarizing Neuro Muscular Blocking Agents (NMBA) on Ultrasound Bowel Peristalsis.

Conditions
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Physiopathology

Intervention / Treatment
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* Drug: injection of placebo
* Drug: injection of NMBA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atracurium<br>injection of NMBA 0.5 mg/kg milligram(s)/kilogram in Intravenous bolus use | Drug: injection of NMBA<br> <br> |
| Experimental: ROCURONIUM<br>injection of NMBA 0.6 mg/kg milligram(s)/kilogram in Intravenous bolus | Drug: injection of NMBA<br> <br> |
| Placebo Comparator: placebo<br>injection of placebo Injection in Intravenous bolus use | Drug: injection of placebo<br>* 0.5 mg/kg milligram(s)/kilogram<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time at which thumb adductor twitch measurement disappears | 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 | 1 month after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analytical, Diagnostic, Anesthesia, Analgesia