Assessment Study of the Effect of NMBA on Bowel Peristalsis

Physiopathology Clinical Trial

— CURARES  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02004015
• Other study ID #: RBM_WTR_2012-9
• Status: Terminated
• Phase: Phase 4
• First received: December 3, 2013
• Last updated: February 10, 2017
• Start date: November 2013

Study information

• Verified date: March 2015
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Physiopathology

Intervention

Drug:
• injection of placebo
0.5 mg/kg milligram(s)/kilogram
• injection of NMBA

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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