Assessment of Cognitive Function After Surgery in Two Types of Anesthesia (General Anesthesia Hypnosedation or Traditional) in Patients Operated for Breast Cancer
Phase: NA
Conditions: Patients With Breast Cancer and Breast Surgery Requiring
Sponsor: Institut Bergonié

Version no. 1 dated 
Page 1 of 4 
 
 
Institut Bergonié 
Bordeaux and Sud-Ouest cancer 
centres 229, cours de l’Argonne 
33076 BORDEAUX Cedex 
 
 
 
 
NCT01880541 
 
Version no. 1 dated |05|11|2009| - IB no.: |2009|–|71| 
 
ID-RCB. no. 2009-A01333-54 
NCT01880541 
 
 
 
Coordinator 
Dr Sylvie Colombani-Claudel 
Department of Anaesthesia, Resuscitation and 
Algology Anaesthetist-Resuscitator 
 
Institut Bergonié 
229, cours de l’Argonne – 33076 Bordeaux Cedex 
Tel: 05.56.33.04.16 Fax: 05.56.33.33.87 E-mail: colombani@bergonie.org 
 
 
 
 
Clinical Research and Epidemiology Unit 
Dr Simone Mathoulin-Pélissier 
Institut Bergonié, Bordeaux 
Unit Head 
 
Carine Bellera 
Institut Bergonié, Bordeaux 
Biostatistician 
 
Patricia Campo 
Institut Bergonié, Bordeaux 
Clinical Research Associate 
 
 
Drug management – Pharmacovigilance unit 
Barbara Lortal 
Institut Bergonié, Bordeaux 
Pharmacist 
 
 
 
EVALUATION OF COGNITIVE FUNCTIONS AFTER 
SURGERY ACCORDING TO TWO TYPES OF 
ANAESTHESIA 
(HYPNOSEDATION OR CONVENTIONAL GENERAL ANAESTHESIA) 
IN PATIENTS UNDERGOING SURGERY FOR BREAST CANCER 
HYPNOSEIN PROTOCOL 
SYNOPSIS 
SPONSOR 
INSTITUT BERGONIÉ 

Version no. 1 dated 
Page 1 of 4 
 
 

Institut Bergonié 
HYPNOSEIN protocol synopsis 
Version no. 1 dated 
Page 2 of 4 
 
 
 
SYNOPSIS 
 
Study title 
Evaluation of cognitive functions after surgery according to two 
types of anaesthesia (hypnosedation or conventional general 
anaesthesia) in patients undergoing surgery for breast cancer 
Acronym 
HYPNOSEIN 
Sponsor 
Institut Bergonié 
Centre de Lutte Contre le Cancer (CRLCC) 
229 Cours de l’Argonne 
33076 Bordeaux Cedex 
Coordinator 
Doctor Sylvie Colombani-Claudel 
Department of Anaesthesia, Resuscitation and 
Algology Institut Bergonié 
Number of 
centres 
3 centres: 
 
Institut Bergonié (Sponsor)
 
Strasbourg (CRLCC)
 
Lille (CRLCC)
Indication 
Patients with breast cancer requiring breast surgery 
Study 
justification 
The onset of cognitive disorders after surgery under general 
anaesthesia (GA) is the second cause of patient complaints (after dental 
injury caused by intubation techniques). These cognitive disorders can 
range from simple reversible confusion (26%) to post-operative 
cognitive dysfunctions without actual recovery (10%). 
Hypnosedation is an old anaesthesia technique which is 
fast-growing, of which the effects on cognitive functions remain 
unknown, but appear to be promising. 
Expected 
results 
The safety of hypnosedation, which uses anaesthetic drugs at doses ten 
times lower than those used during general anaesthesia, could be 
demonstrated on cognitive functions, and thus become 
an anaesthetic alternative, in certain types of surgery, in patients at 
risk of post-operative cognitive dysfunction. 
Objectives 
Primary objective: 
Evaluate the change in cognitive functions in patients treated for breast 
cancer by surgery, according to the type of anaesthesia chosen by the 
patient: hypnosedation or conventional general anaesthesia. 
Secondary objectives: 
Evaluate the characteristics of patients (physiological, mental and 
sociocultural) according to the type of anaesthesia selected, in order to 
identify characteristics likely to predict the choice of hypnosedation. 
According to the type of anaesthesia, evaluate the following, before and
after surgery: 
pain, level of anxiety and patient satisfaction with the anaesthesia 
technique. 
Study design 
Observational, prospective, exploratory, multicentric study in 2 
groups, according to the type of anaesthesia selected: hypnosedation 
or general anaesthesia 
Number of 
patients 
50 assessable patients (25 in each group) 
Inclusion 
criteria 
 
Females, age 18 to 80 years, 
 
Confirmed breast cancer diagnosis (positive pathology test), 
 
Life expectancy greater than 6 months, 
 
Breast tumour resection with or without lymph node removal, 
mastectomy with or without lymph node removal, 
isolated lymph node removal, 

Institut Bergonié 
HYPNOSEIN protocol synopsis 
Version no. 1 dated 
Page 3 of 4 
 
 
 
 
ASA 1 (patient in normal health) or 2 (patient with mild systemic 
disease) according to the classification by the American Society of 
Anesthesiologists, 
 
Affiliation to a social security scheme, 
 
Subject informed and informed consent form signed 
Exclusion 
criteria 
 
Presence of major psychotic psychiatric disorders or addictive 
behaviour, evaluated by the neuropsychologist at the first 
preoperative consultation, using the MINI test (MINI > 4 positive 
responses for each module) 
 
Presence of treated or untreated known neurological disorders, 
evaluated by the neuropsychologist at the first preoperative 
consultation, using the MMSE test (MMSE < 24) 
 
Patients on oral morphine for longer than 3 months, 
 
Pregnant or breastfeeding patients, or patients of childbearing age 
not using the appropriate contraception, 
 
Patient included in another clinical study, 
 
Subjects unable to undergo medical follow-up during the trial for 
geographical, social or psychological reasons, 
 
Patients deprived of freedom and adults subject to legal protection 
measures or unable to give their consent. 
Study 
procedure 
 
Screening visit: Pre-anaesthesia consultation (more than 
48h before surgery) 
The anaesthetist checks the inclusion and exclusion criteria and 
describes in detail the two management methods proposed by the 
study. An information document and consent form is handed to 
patients. 
 
Preoperative consultation (D – 1: day before surgery) On 
admission, the patient meets with the anaesthetist who ensures they 
have the patient’s consent to participate and that they have signed an 
informed consent document, before they are referred for the 
neuropsychological consultation. 
After the eligibility consultation, the patient is confirmed or not, 
based on the results of the MINI and MMSE tests. 
 
Inclusion visit: pre-anaesthesia visit: inclusion The 
anaesthetist informs the patient of the results of the 
neuropsychological consultation and whether she meets the eligibility 
criteria. They question the patient on the type of anaesthesia chosen, 
either general anaesthesia or hypnosedation. 
This information is recorded on the inclusion form that the anaesthetist 
forwards to the Clinical Research Associate in charge of the study. 
 
Per- and post-operative analgesic protocol (regardless of 
the type of anaesthesia) 
Slow direct intravenous injection of Proparacetamol / 6 h and slow 
direct intravenous injection of Ketoprofen / 8 to 12 h, and morphine if 
the numerical scale is  4. Follow-on oral analgesic treatment with 
paracetamol and ibuprofen. 
 
Hypnosedation protocol 
Patients receive Alprazolam 0.25 premedication 1 hour before surgery. 
The anaesthetist begins induction of hypnosis by asking the patient to 
close her eyes or to stare 
at a specific point. They continue with bodily relaxation and work on 

Institut Bergonié 
HYPNOSEIN protocol synopsis 
Version no. 1 dated 
Page 4 of 4 
 
 
 
breathing; at the same time, they begin sedation with a morphinic 
(remifentanyl 0.05/kg/min to 0.1/kg/min) and midazolam (0.5 to 1.5 
mg). The surgeon administers the local anaesthetic which is a mixture 
of 10 cc xylocaine 2% and 10 cc marcaine 0.5%. The anaesthetist 
deepens the trance by suggesting the happy memory chosen 
beforehand by the patient, and remains constantly in contact with the 
patient, and also the surgeon, as mediator between the two. 
From the start of closure of the surgical wound, the anaesthetist stops 
sedation and gradually brings the patient out of her hypnotic state. 
 
General anaesthesia protocol 
After pre-oxygenation with the face mask for 5 min, anaesthesia 
induction and maintenance take place according to standard practice, 
using propofol and remifentanyl by TCI (target-controlled infusion), the 
airways being controlled by a laryngeal mask or intubation tube, and 
drug administration being stopped on dressing placement. 
 
Surgery 
The standard surgeries concerned are breast tumorectomy with or 
without lymph node removal, mastectomy with or without lymph node 
removal, isolated lymph node removal, tumorectomy or even 
mastectomy with sentinel lymph node identification, sentinel lymph 
node isolated identification. 
 
Immediate post-operative assessment (D1 to D7) and 
check-up (1 month later) 
 Evaluations of cognitive functions by the neuropsychologists 
 Pain, anxiety, morphine treatments by the 
anaesthetist/resuscitator 
Endpoints 
We will evaluate cognitive disorders with a series of validated 
neuropsychological 
tests, 
including 
a 
cognitive 
complaint 
questionnaire for subjective cognitive disorders, and Grober and 
Buschke memory test, attentional tests and executive function tests 
for objective cognitive disorders. Pain and satisfaction in 
patients will be assessed using a numerical scale, and emotional state 
using the HAD scale. 
Statistical 
analyses 
The scores for each of the tests concerning subjective and objective 
cognitive function disorders and assessment of pain and anxiety will be 
described using descriptive statistics (mean, median, minimum and 
maximum) and graphs, at the 3 assessment intervals (preoperative, 
immediately after surgery and one 
month after surgery), overall and according to the type of anaesthesia.
Schedule 
 
Start of inclusions: March 2010 
 
Inclusion phase: March 2010 to February 2012 
 
Participation time of each patient: 1 month 
 
Total study duration: 2 years and 1 month