AnesthesiaHypnose2NCT02249364
Hypnosis Before the Induction of Anesthesia
A study testing Hypnosis and propofol in people with Anesthesia, run by Hopital Foch at 1 site in France.
Trial summary
Hypnosis may reduce patient anxiety. The main goal of this study is to determine in what extent, hypnosis decreases propofol requirement to induce induction of general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anesthesia
- What is being tested?
- Hypnosis and propofol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female patients scheduled for a one day gynecological surgical procedures under general anesthesia
Who cannot join
- pregnancy, breast feeding woman
- allergy to propofol, soy or peanuts
- history of central nervous system disease
- psychiatric affection
- hypovolemia, high cardiovascular risk
- patients with a pace-maker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Hypnosis Before the Induction of Anesthesia. Study in Women Submitted to One Day Gynecological Surgical Procedures
Hypnosis may reduce patient anxiety. The main goal of this study is to determine in what extent, hypnosis decreases propofol requirement to induce induction of general anesthesia.
Two particular aspects of this study are
- the inclusion of women undergoing one day gynecological surgical procedures
- the use of a closed-loop system which delivers propofol according to bispectral index to provide induction of anesthesia.
- Conditions
- Anesthesia
- Being tested
- Control, Hypnosis, propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlProcedure or surgery
Routine practice
HypnosisProcedure or surgery
Hypnosis session before induction of anesthesia
propofolDrug
Closed-loop administration of propofol for anesthesia induction
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard care without hypnosis session followed by closed-loop administration of propofol for anesthesia induction Receives: Procedure: Control; Drug: propofol |
| Hypnosis | Experimental | Hypnosis session followed by closed-loop administration of propofol for anesthesia induction Receives: Procedure: Hypnosis; Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Administered dose of propofol
Administered dose of propofol required to obtain the induction of anesthesia (bispectral index <60 for at least 30 seconds)
Measured: one hour
Secondary outcomes (11)
Target plasma concentration of propofol
Target plasma concentration of propofol corresponding to induction of anesthesia (bispectral index <60 for at least 30 seconds)
Measured: one hour
Pain of insertion of peripheral vein catheter
Pain is assessed by two criteria:
- withdrawal of the arm perfused (no = 0; withdrawal = 1; violent withdrawal = 2),
- spontaneous expression (no = 0; frown = 1; grin or verbal complaint = 2)
Measured: one hour
Pain due to injection of propofol
Pain is assessed by two criteria:
- withdrawal of the arm perfused (no = 0; withdrawal = 1; violent withdrawal = 2),
- spontaneous expression (no = 0; frown = 1; grin or verbal complaint = 2)
Measured: one hour
Effect of hypnosis on bispectral index
Effect of hypnosis on bispectral index before the induction of anesthesia
Measured: one hour
Time to loss of consciousness
Time between the beginning of injection of propofol and the loss of eyelash reflex
Measured: one hour
Hemodynamic consequences of induction of anesthesia
Heart rate and blood pressure are measured just before induction of anesthesia and once it is realized.
Measured: one hour
Administration of a cardio-vascular agent
Administration of ephedrine, atropine or of an hypotensive agent
Measured: one hour
Manipulation of the airway
Necessity of a jaw thrust maneuver or of another manipulation of the airway during the induction of anesthesia
Measured: one hour
Characteristics of the hypnotic procedure evaluated by the clinician in the group "hypnosis"
The hypnotic procedure is assessed by three criteria:
- receptivity of the patient (yes/no),
- rapidity of focalization procedure (very fast, fast, medium, delayed, impossible to obtain),
- quality of the hypnotic trance (very deep, deep, medium, superficial, not obtained).
Measured: one hour
Characteristics of the hypnotic procedure evaluated by the patient in the group "hypnosis"
The hypnotic procedure is assessed by a question : "Did you visualize the memory we talked about before the session ? (yes, no )
Measured: six hours
Characteristics of the preanesthetic management evaluated by the patient (all the patients)
The preanesthetic management is assessed by one criteria:"How do you rate the quality of the preanesthetic period (from the entrance in the operating room to the induction of the general anesthesia ?" (excellent, good, average, not good)
Measured: Six hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, Study chair, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249364
- Sponsor's protocol ID
- 2013/49
- Other IDs
- 2013-A01640-45
- Acronym
- Hypnose2
- Status last verified
- Oct 2016
- First submitted
- 23 Sep 2014
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.
PubMed 16571963Bataille A, Guirimand A, Szekely B, Michel-Cherqui M, Dumans V, Liu N, Chazot T, Fischler M, Le Guen M. Does a hypnosis session reduce the required propofol dose during closed-loop anaesthesia induction?: A randomised controlled trial. Eur J Anaesthesiol. 2018 Sep;35(9):675-681. doi: 10.1097/EJA.0000000000000751.
PubMed 29210845
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Hypnosis Before the Induction of Anesthesia. Study in Women Submitted to One Day Gynecological Surgical Procedures
- ClinicalTrials.gov ID
- NCT02249364
- Acronym / sponsor ID
- Hypnose2 / 2013/49
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypnosis may reduce patient anxiety. The main goal of this study is to determine in what extent, hypnosis decreases propofol requirement to induce induction of general anesthesia.
Two particular aspects of this study are
- the inclusion of women undergoing one day gynecological surgical procedures
- the use of a closed-loop system which delivers propofol according to bispectral index to provide induction of anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Control, Drug: propofolStandard care without hypnosis session followed by closed-loop administration of propofol for anesthesia induction |
| Hypnosis | Experimental | Procedure: Hypnosis, Drug: propofolHypnosis session followed by closed-loop administration of propofol for anesthesia induction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult female patients scheduled for a one day gynecological surgical procedures under general anesthesia
Key exclusion criteria (6 listed)
- pregnancy, breast feeding woman
- allergy to propofol, soy or peanuts
- history of central nervous system disease
- psychiatric affection
- hypovolemia, high cardiovascular risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlRoutine practice | Procedure or surgery | Control |
| HypnosisHypnosis session before induction of anesthesia | Procedure or surgery | Hypnosis |
| propofolClosed-loop administration of propofol for anesthesia induction | Drug | Control, Hypnosis |
Primary outcome
Administered dose of propofol
Time frame: one hour
Administered dose of propofol required to obtain the induction of anesthesia (bispectral index <60 for at least 30 seconds)
11 secondary outcomes
Target plasma concentration of propofol
Time frame: one hour
Pain of insertion of peripheral vein catheter
Time frame: one hour
Pain due to injection of propofol
Time frame: one hour
Effect of hypnosis on bispectral index
Time frame: one hour
Time to loss of consciousness
Time frame: one hour
Hemodynamic consequences of induction of anesthesia
Time frame: one hour
Administration of a cardio-vascular agent
Time frame: one hour
Manipulation of the airway
Time frame: one hour
Characteristics of the hypnotic procedure evaluated by the clinician in the group "hypnosis"
Time frame: one hour
Characteristics of the hypnotic procedure evaluated by the patient in the group "hypnosis"
Time frame: six hours
Characteristics of the preanesthetic management evaluated by the patient (all the patients)
Time frame: Six hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Background: PubMed 16571963Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.
- Derived from this study: PubMed 29210845Bataille A, Guirimand A, Szekely B, Michel-Cherqui M, Dumans V, Liu N, Chazot T, Fischler M, Le Guen M. Does a hypnosis session reduce the required propofol dose during closed-loop anaesthesia induction?: A randomised controlled trial. Eur J Anaesthesiol. 2018 Sep;35(9):675-681. doi: 10.1097/EJA.0000000000000751.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Fischler study chair
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis and propofol in people with Anesthesia, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Administered dose of propofol (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02249364, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.