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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01752283
Enrollment
130
Registered
2012-12-19
Start date
2010-01-31
Completion date
2012-06-30
Last updated
2012-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Keywords

Videoassited, Thyroidectomy, Minimal invasive surgery, General anesthesia, Hypnosis

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.

Interventions

PROCEDUREvideo-assisted thyroidectomy

Experimental arm: video-assisted thyroidectomy under local anesthesia and hypnosis

PROCEDUREVideo-assisted thyroidectomy

video-assisted thyroidectomy under general anesthesia

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
FeasibilityIntraoperativeTo assess technical feasibility

Secondary

MeasureTime frame
Operating timeduring surgery
Intraoperative bleedingDuring surgery
Conversion to general anesthesiaDuring surgery
Conversion from video-assisted technique to conventional surgeryDuring surgery

Other

MeasureTime frame
Hemodynamic changesDuring surgery
Drug consumptionDuring surgery and up to 6 hours after surgery

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026