AnesthesiaPhase 4LoopHypnosisNCT01648725
Hypnosis and Closed-Loop Anesthesia System
A Phase 4 study testing Hypnosis 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
- Conditions the study is for
- Anesthesia
- What is being tested?
- Hypnosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to Dec 2013
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients scheduled for a surgical procedure under general anesthesia
Who cannot join
- pregnancy, breast feeding woman
- allergy to propofol, soy or peanuts
- history of central nervous system disease
- patient receiving a psychotropic treatment
- patient treated by a psychiatrist or a psychologist
- hypovolemia, high cardiovascular risk
- patients with a pace-maker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Hypnosis on the Propofol Requirement to Induce General Anesthesia
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.
A particular aspect of this study is that induction is provided by a closed-loop system which delivers propofol according to bispectral index.
- Conditions
- Anesthesia
- Being tested
- Hypnosis, usual care
- Keywords
- Hypnosis, Anesthesia, Propofol, Closed-loop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisProcedure or surgery
A short preanesthetic hypnosis before induction of anesthesia
usual careProcedure or surgery
Standard care before induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis | Experimental | standard care plus hypnosis followed by closed-loop administration of propofol for anesthesia induction Receives: Procedure: Hypnosis |
| Control | Active comparator | standard care without hypnosis followed by closed-loop administration of propofol for anesthesia induction Receives: Procedure: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Administered dose of propofol required to obtain the induction of anesthesia (bispectral index <60 for at least 30 seconds)
Measured: one hour
Secondary outcomes (6)
calculated target plasma concentration corresponding to induction of anesthesia (bispectral index <60 for at least 30 seconds)
Measured: one hour
pain of injection
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 = 2)
Measured: one hour
Hemodynamic consequences of induction of anesthesia
Heart rate and blood pressure are measured just before induction of anesthesia and once it realized.
Measured: one hour
characteristics of the hypnotic procedure
- For speed: focus obtained in a very fast (1), fast (2), medium (3), delayed (4), impossible to obtain (5).
- For quality: very deep (1), deep (2), medium (3), superficial (4), not obtained (5)
Measured: one hour
Patient assessment of the induction of anesthesia
4-point scale.
Measured: one hour
Time to loss of consciousness
loss of eyelash reflex
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Szekely, MD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648725
- Sponsor's protocol ID
- 2012/12
- Other IDs
- 2012-A00369-34
- Acronym
- LoopHypnosis
- Status last verified
- Oct 2016
- First submitted
- 20 Jul 2012
- 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 16571963
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
- Influence of Hypnosis on the Propofol Requirement to Induce General Anesthesia
- ClinicalTrials.gov ID
- NCT01648725
- Acronym / sponsor ID
- LoopHypnosis / 2012/12
- Conditions
- Anesthesia
- Keywords
- Hypnosis, Anesthesia, Propofol, Closed-loop
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Jul 2012 (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.
A particular aspect of this study is that induction is provided by a closed-loop system which delivers propofol according to bispectral index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis | Experimental | Procedure: Hypnosisstandard care plus hypnosis followed by closed-loop administration of propofol for anesthesia induction |
| Control | Active comparator | Procedure: usual carestandard care without hypnosis followed by closed-loop administration of propofol for anesthesia induction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients scheduled for a surgical procedure under general anesthesia
Key exclusion criteria (7 listed)
- pregnancy, breast feeding woman
- allergy to propofol, soy or peanuts
- history of central nervous system disease
- patient receiving a psychotropic treatment
- patient treated by a psychiatrist or a psychologist
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 |
|---|---|---|
| HypnosisA short preanesthetic hypnosis before induction of anesthesia | Procedure or surgery | Hypnosis |
| usual careStandard care before induction of anesthesia | Procedure or surgery | Control |
Primary outcome
Administered dose of propofol required to obtain the induction of anesthesia (bispectral index <60 for at least 30 seconds)
Time frame: one hour
6 secondary outcomes
calculated target plasma concentration corresponding to induction of anesthesia (bispectral index <60 for at least 30 seconds)
Time frame: one hour
pain of injection
Time frame: one hour
Hemodynamic consequences of induction of anesthesia
Time frame: one hour
characteristics of the hypnotic procedure
Time frame: one hour
Patient assessment of the induction of anesthesia
Time frame: one hour
Time to loss of consciousness
Time frame: one hour
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.
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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.
Barbara Szekely, MD principal investigator
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hypnosis 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 7 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 required to obtain the induction of anesthesia (bispectral index <60 for at least 30 seconds) (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 NCT01648725, which also lists 1 linked publication.
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.