Video-assisted Thyroid Surgery and Hypnosis in Thyroid Surgery

Not Applicable

Completed

• Conditions: Surgery
• Interventions: Procedure: Video-assisted thyroidectomy

• Registration Number: NCT01752283
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

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

Detailed Description

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

1. 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.

2. Inclusion criteria

* Adult patients candidates to total or partial thyroidectomy.

* ASA 1, 2 or 3

* One surgeon (MM)

* Informed consent

3. 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

4. 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.

5. 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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-12
• Study Completion: 2012-06
• Study First Submitted: 2012-10-31
• Status Verified: 2012-12
• Study First Submitted QC: 2012-12-18
• Last Update Submitted: 2012-12-18
• Study First Posted: 2012-12-19
• Last Update Posted: 2012-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anesthesia	Video-assisted thyroidectomy	Video-assisted thyroidectomy under general anesthesia
Hypnosis and local anesthesia	Video-assisted thyroidectomy	video-assisted thyroidectomy under hypnosis and local anesthesia.

Primary Outcome Measures

Name	Time	Method
Feasibility	Intraoperative	To assess technical feasibility

Secondary Outcome Measures

Name	Time	Method
Intraoperative bleeding	During surgery
Operating time	during surgery
Conversion from video-assisted technique to conventional surgery	During surgery
Conversion to general anesthesia	During surgery

Trial Locations

Locations (1)

Cliniques Universitaires Saint-Luc. 10 Avenue Hippocrate; 🇧🇪 Brussels, Belgium