Video-assisted Thyroid Surgery and Hypnosis in Thyroid Surgery

Study Overview
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Brief Summary
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The study is aimed to investigate the safety and feasibility of Video-assisted thyroidectomy under hypnosis in comparison to general anesthesia

Detailed Description
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Summary of the project video-assisted thyroidectomy (MIVAT): General anesthesia (GA) versus hypnosis (HY) Investigators Prof. Michel Mourad*, Dr. Christine Watremez **, Prof. Fabienne Roelants** * Surgery and Abdominal Transplantation Division ** Department of Anesthesiology, Université Catholique de Louvain, Cliniques Universitaires Saint-Luc, Avenue Hippocrate 10, 1200 Brussels, Belgium Aim The aim of this pilot study is to prospectively investigate, in a consecutive series of patients, the feasibility and safety of MIVAT under HY associated with local anesthesia, compared to GA. Inclusion criteria Adult patients candidates to total or partial thyroidectomy. ASA 1, 2 or 3 One surgeon (MM) Informed consent Exclusion criteria Age <18 years The presence of familial medullary thyroid cancers Suspicious or metastatic lymph nodes Redo surgery ASA 4 patients Patients with chronic pain Deaf people Patients with psychiatric diseases Known recurrent nerve paralysis Outcome evaluation Primary outcomes: safety and feasibility. During surgery, considered events for analysis should include operating time (from skin incision to skin closure), total time in the operating room, intraoperative bleeding, drug consumption, Hemodynamic changes and conversion rates from MIVAT to a conventional approach and from HY to GA. After surgery, comparative variables for analysis should include: drug consumption, hospital stay, calcemia, and vocal cord abnormality on the basis of day-one laryngoscopy performed by an ENT doctor not involved in the study. Patients selection and study groups: Selection of patients for MIVAT is based on the size of the gland and nodules, provided that the craniocaudal axis of the lobes did not exceed 7cm and the largest transversal diameter was less than 3.5cm. All patients who are assigned to undergo MIVAT are instructed about the possibility of conversion to a conventional approach. The patients are left free to choose the type of anesthesia they prefere for their surgical intervention. They have to give informed consent before the procedure. A. General anesthesia group: Premedication: Lorazepam 0.5 mg 1 h before surgery ECG, NIBP, SaO2 VVP + NaCl 0.9 % 500 mL + taradyl 0.5 mg / kg (<30 mg) Induction: Remifentanil 0.05 µg/kg/min Propofol 2 mg/kg Intubation with an armored endotracheal tube specially devised for neuromonitoring of the vocal cords. During surgery: Sevoflurane / Remifentanil B. Hypnosis group: Premedication: Lorazepam 0.5 mg 1 h avant l'intervention ECG, NIBP, SaO2 VVP + NaCl 0.9 % 500 mL + taradyl 0.5 mg / kg (< 30 mg) Induction and during surgery: Remifentanil modified as requested Induction of hypnosis according to Milton Eriksson technique Midazolam (titrated 0.1 mg/0.1mg) if needed as anxiolytic. Local anesthesia mixture (lidocaine 0.5%/ropivacaine 0.25%) to be administered by the surgeon along the incision line 5 minutes before making the skin incision.

Official Title
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Combination of Video-assisted Thyroid Surgery and Hypnosis as a Complete Minimally Invasive Approach: a Comparative Pilot Study

Conditions
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Surgery

Intervention / Treatment
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* Procedure: video-assisted thyroidectomy
* Procedure: Video-assisted thyroidectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The selection of patients for MIVAT was achieved according to the size of the gland and nodules provided that the cranio-caudal axis of the lobes does not exceed 7 centimeters and the largest transversal diameter is less than 3.5 centimeters Age >18 years Exclusion Criteria: No previous neck surgery No known malignancy No history of neck irradiation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnosis and local anesthesia<br>video-assisted thyroidectomy under hypnosis and local anesthesia. | Procedure: video-assisted thyroidectomy<br>* Experimental arm: video-assisted thyroidectomy under local anesthesia and hypnosis<br>Procedure: Video-assisted thyroidectomy<br>* video-assisted thyroidectomy under general anesthesia<br>|
| Active Comparator: General anesthesia<br>Video-assisted thyroidectomy under general anesthesia | Procedure: video-assisted thyroidectomy<br>* Experimental arm: video-assisted thyroidectomy under local anesthesia and hypnosis<br>Procedure: Video-assisted thyroidectomy<br>* video-assisted thyroidectomy under general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | To assess technical feasibility | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating time |  | during surgery | 
| Intraoperative bleeding |  | During surgery | 
| Conversion to general anesthesia |  | During surgery | 
| Conversion from video-assisted technique to conventional surgery |  | During surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Videoassited, Thyroidectomy, Minimal invasive surgery, General anesthesia, Hypnosis