Video-assisted Thyroid Surgery and Hypnosis in Thyroid Surgery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752283
• Other study ID #: Video-Hypnose
• Status: Completed
• Phase: N/A
• First received: October 31, 2012
• Last updated: December 18, 2012
• Start date: January 2010
• Est. completion date: June 2012

Study information

• Verified date: December 2012
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Surgery

Intervention

Procedure:
• video-assisted thyroidectomy
Experimental arm: video-assisted thyroidectomy under local anesthesia and hypnosis
• Video-assisted thyroidectomy
video-assisted thyroidectomy under general anesthesia

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc. 10 Avenue Hippocrate	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemodynamic changes		During surgery	Yes
Other	Drug consumption		During surgery and up to 6 hours after surgery	Yes
Primary	Feasibility	To assess technical feasibility	Intraoperative	Yes
Secondary	Operating time		during surgery	Yes
Secondary	Intraoperative bleeding		During surgery	Yes
Secondary	Conversion to general anesthesia		During surgery	Yes
Secondary	Conversion from video-assisted technique to conventional surgery		During surgery	Yes