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Premature termination of the study because it was dependent on the Remicrush study which ended more quickly, not allowing the inclusion of the expected number of patients.
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VHIntubation is a French monocentric and observational study that will assess the impact of two intra-tracheal intubation preparation procedures (curarization versus remifentanil) on the voice, using the Voice Handicap Index (VHI) self-questionnaire.
Some surgeries are known to expose patients to voice disorders (thyroidectomy, parathyroidectomy, carotid surgery…). However, voice disorders can be due, among other things, to a laryngeal nerves alteration and intubation trauma. Our team has published 2 prospective studies on the frequency of voice troubles after thyroidectomy (Borel et al. Surgery 2018 and 2019).
To limit post tracheal intubation voice troubles , it is generally recommended to practice intra-tracheal intubation with a curarization (Lundstrøm et al. Br J Anaesth 2018). However, for few years, the very vast majority of thyroid surgery is practiced with a neuromonitoring of laryngeal nerves (NIM). NIM ensures prosper functioning of the vocal cords intra- and post-operatively with an excellent negative predictive value (>98%, Mirallié et al. Surgery 2018). However, the use of NIM requires an absence of curarization. Some centres, including ours, have abandoned systematic curarization before intubation for thyroidectomy; other centres continue to practice curarization with, sometimes, the need to antagonize curarization for an effective NIM utilization.
The aim of this study is to assess the impact of intubation preparation procedures (curarization versus remifentanil) on the voice using Voice Handicap Index (VHI) questionnaire.
The Nantes University Hospital is the sponsor of " REMICRUSH ", study on " Assessment of Remifentanil for Rapid Sequence Induction and Intubation in Full Stomach Patient Compared to Muscle Relaxant. A Non-inferiority Simple Blind Randomized Controlled Trial ", the coordinator of which is Dr Nicolas Grillot.
This study began in October 2019 and authorisations are obtained. We aim to propose our study " VHIntubation " to patients participating in REMICRUSH in order to benefit from REMIFENTANIL versus CURARE randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remifentanil group | bolus intravenous injection of 3 to 4µg/kg of remifentanil after hypnotic administration for a crush anesthetic induction |
| |
| Neuromuscular blockade group | Bolus intravenous injection of 1mg/kg of Succinylcholine or Rocuronium after hypnotic administration for a crush anesthetic induction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voice Handicap Questionnaire (VHI) | Other | Voice Handicap Index (VHI) self-questionnaire |
|
| Measure | Description | Time Frame |
|---|---|---|
| Voice Handicap at 1 month post-intubation | Evaluate the impact of the procedures to prepare at intra-tracheal intubation (curarization versus remifentanil) on the voice, using Voice Handicap Index (VHI) self-questionnaire at 1 month post-intubation. Primary endpoint is the evolution of the score at VHI questionnaire (Voice Handicap Index) at 1 month post-intubation, the reference is the pre-intubation score. An augmentation of 18 points score is considered as significant (Borel et al. Surgery 2018). | 1 month post-intubation |
| Measure | Description | Time Frame |
|---|---|---|
| Voice Handicap at 6 month post-intubation | Evaluate the impact of the procedures to prepare at intra-tracheal intubation (curarization versus remifentanil) on the voice, using Voice Handicap Index (VHI) self-questionnaire at 6 month post-intubation. Primary endpoint is the evolution of the score at VHI questionnaire (Voice Handicap Index) at 6 month post-intubation, the reference is the pre-intubation score. An augmentation of 18 points score is considered as significant (Borel et al. Surgery 2018). |
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Inclusion Criteria:
Inclusions criteria in REMICRUSH are :
Exclusion Criteria:
Exclusion criteria in REMICRUSH are :
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The Nantes University Hospital is the sponsor of " REMICRUSH ", study on " Assessment of Remifentanil for Rapid Sequence Induction and Intubation in Full Stomach Patient Compared to Muscle Relaxant. A Non-inferiority Simple Blind Randomized Controlled Trial ", We aim to propose our study " VHIntubation " to patients participating in REMICRUSH in order to benefit from REMIFENTANIL versus CURARE randomization.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes University Hospital | Nantes | 44093 | France |
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| 6 month post-intubation |