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

Fondation Ophtalmologique Adolphe de Rothschild

Status and phase: Terminated; Phase 4

Conditions: Physiopathology

Treatments: Drug: injection of placebo; Drug: injection of NMBA

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02004015

RBM_WTR_2012-9

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 3 patient groups, including a placebo group

Atracurium

Experimental group

Description:

injection of NMBA 0.5 mg/kg milligram(s)/kilogram in Intravenous bolus use

Treatment:

Drug: injection of NMBA

ROCURONIUM

Experimental group

Description:

injection of NMBA 0.6 mg/kg milligram(s)/kilogram in Intravenous bolus

Treatment:

Drug: injection of NMBA

placebo

Placebo Comparator group

Description:

injection of placebo Injection in Intravenous bolus use

Treatment:

Drug: injection of placebo