Video-assisted Thyroid Surgery and Hypnosis in Thyroid Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Procedure: video-assisted thyroidectomy; Procedure: Video-assisted thyroidectomy

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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc. 10 Avenue Hippocrate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
Hemodynamic changes	During surgery
Drug consumption	During surgery and up to 6 hours after surgery

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Michel Mourad, MD, PhD, Cliniques Universitaires Saint-Luc. 10 Avenue Hippocrate, 10. 1200 Bruxelles

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: October 31, 2012
• First Submitted That Met QC Criteria: December 18, 2012
• First Posted (Estimate): December 19, 2012

Study Record Updates

• Last Update Posted (Estimate): December 19, 2012
• Last Update Submitted That Met QC Criteria: December 18, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Hypnosis; Thyroidectomy; General anesthesia; Minimal invasive surgery; Videoassited
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: Video-Hypnose