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

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ClinicalTrials.gov Identifier: NCT02825121
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

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
Observation of Neuromuscular Block Flexor Hallucis Adductor Pollicis Device: Monitoring Neuromuscular Blockade the Flexor Hallucis Device: Monitoring Neuromuscular Blockade adductor of the thumb. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : February 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

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.



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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825121


Locations
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France
Poitiers Universitary Hospital
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT02825121    
Other Study ID Numbers: CURHATOF
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2016
Additional relevant MeSH terms:
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Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs