Assessment Study of the Effect of NMBA on Bowel Peristalsis

Phase 4TerminatedNCT02004015

Fondation Ophtalmologique Adolphe de Rothschild50 enrolled

Overview

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

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Physiopathology

Interventions

injection of placeboDRUG

0.5 mg/kg milligram(s)/kilogram

injection of NMBADRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, France

Outcomes

Primary Outcomes

Proportion of patients with a score of motion = 0

Time frame: 10 minutes after NMBA or placebo injection

Secondary Outcomes

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

Time frame: 1 month after injection

Data from ClinicalTrials.gov

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