Assessment Study of the Effect of NMBA on Bowel Peristalsis

Phase 4

Terminated

• Conditions: Physiopathology
• Interventions: Drug: injection of NMBA; Drug: injection of placebo

• Registration Number: NCT02004015
• Lead Sponsor: 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

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 Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-06
• Status Verified: 2015-03
• Primary Completion: 2015-04
• Last Update Submitted: 2017-02-10
• Last Update Posted: 2017-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atracurium	injection of NMBA	injection of NMBA 0.5 mg/kg milligram(s)/kilogram in Intravenous bolus use
ROCURONIUM	injection of NMBA	injection of NMBA 0.6 mg/kg milligram(s)/kilogram in Intravenous bolus
placebo	injection of placebo	injection of placebo Injection in Intravenous bolus use

Primary Outcome Measures

Name	Time	Method
Proportion of patients with a score of motion = 0	10 minutes after NMBA or placebo injection	Proportion of patients with a score of motion = 0

Secondary Outcome Measures

Name	Time	Method
Time at which thumb adductor twitch measurement disappears	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

Trial Locations

Locations (1)

Fondation Ophtalmologique Adolphe de Rothschild; 🇫🇷 Paris, France