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

Sponsor
Poitiers University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02825121
Collaborator
(none)
60
1
1
19
3.2

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Device: Monitoring Neuromuscular Blockade the Flexor Hallucis
  • Device: Monitoring Neuromuscular Blockade adductor of the thumb.
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Sep 1, 2017
Actual Study Completion Date :
Sep 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Monitoring Neuromuscular Blockade

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.

Outcome Measures

Primary Outcome Measures

  1. Time of occurrence of a T4 / T1 ratio> 0.90 in the train of four flexor hallucis [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Poitiers Universitary Hospital Poitiers France 86021

Sponsors and Collaborators

  • Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT02825121
Other Study ID Numbers:
  • CURHATOF
First Posted:
Jul 7, 2016
Last Update Posted:
Oct 5, 2017
Last Verified:
Oct 1, 2016
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2017