Evaluation of Monitoring Neuromuscular Blockade the Flexor Hallucis Compared to the Adductor Pollicis

NCT02825121 | Completed

• 1 other identifier: CURHATOF
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Current guidelines recommend monitoring of neuromuscular blockade at the adductor pollicis by stimulation of the ulnar nerve at the wrist. However, in certain situations (laparoscopic surgery, cranial surgery or surgical comfort, arterial catheterization), it is impossible to access the patient's wrists, delaying monitoring, antagonizing the neuromuscular block, the emergence from anesthesia and patient extubation , leading in some cases to single injections lack of control of the reversal of the patient. To overcome these technical difficulties, a group nerve / muscle looks interesting and often easily accessible to the anesthesiologist. The stimulation of the posterior tibial nerve can observe a response to the flexor hallucis brevis muscle and allows quick access to monitoring the reversal before the end of the intervention. The primary outcome was to compare the speed of recovery from neuromuscular block flexor hallux versus that of the adductor pollicis. The secondary objective was to compare the speed of installation of deep neuromuscular block flexor hallucis versus that of the adductor pollicis. This is a prospective, exploratory, uncontrolled, single-center for routine care. Are included all aged patients over 18 years, ASA I or II, without guardianship, having no known allergy to Atracurium, without neuromyopathy known, emergency surgery or full stomach, predictable difficult intubation .

Conditions

Observation of Neuromuscular Block; Flexor Hallucis; Adductor Pollicis

Outcome Measures

Primary Outcomes (1)

• Time of occurrence of a T4 / T1 ratio> 0.90 in the train of four flexor hallucis

  1 day

Study Arms (1)

Monitoring Neuromuscular Blockade

EXPERIMENTAL

Monitoring Neuromuscular Blockade the Flexor Hallucis and adductor of the thumb.

Device: Monitoring Neuromuscular Blockade the Flexor Hallucis; Device: Monitoring Neuromuscular Blockade adductor of the thumb.

Interventions

Monitoring Neuromuscular Blockade the Flexor Hallucis DEVICE

Monitoring Neuromuscular Blockade

Monitoring Neuromuscular Blockade adductor of the thumb. DEVICE

Monitoring Neuromuscular Blockade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over 18 years
• Any elective surgery with single or multiple injection Atracurium for which hand and foot are accessible at the same time.
• ASA I or II patients
• free subject, without guardianship or subordination
• No opposition given by the patient after information

You may not qualify if:

• under 18 years
• known neuromyopathy
• Diabetics
• Emergency surgery and a full stomach
• predictable difficult intubation
• Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Poitiers Universitary Hospital

Poitiers, 86021, France

Location

Related Publications (1)

• Le Merrer M, Frasca D, Dupuis M, Debaene B, Boisson M. A comparison between the flexor hallucis brevis and adductor pollicis muscles in atracurium-induced neuromuscular blockade using acceleromyography: A prospective observational study. Eur J Anaesthesiol. 2020 Jan;37(1):38-43. doi: 10.1097/EJA.0000000000001090.

  PMID: 31592900 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2016
• First Posted: July 7, 2016
• Study Start: February 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 5, 2017

Record last verified: 2016-10

Locations

FR (1)