Minimally Invasive SurgeryNCT02505880
Hypnosis Versus General Anesthesia in Pediatric Surgery: Clinical and Medico-economic Interests
A study testing Local anesthetic + Hypnosis and General anesthesia in people with Minimally Invasive Surgery, run by University Hospital, Montpellier at 1 site in France.
Trial summary
In adults, it is common to perform a number of superficial and non invasive surgeries under local anesthesia in order to limit the use of general anesthesia. Hypnosis is a nonpharmacological therapies that can be used during surgery to improve the patient comfort and experience. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Minimally Invasive Surgery
- What is being tested?
- Local anesthetic + Hypnosis and General anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to 12 Aug 2018
- 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 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient hospitalized in infantile ambulatory surgery unit
- Patient whose general state corresponds to the classification of the American Society of Anesthesiologists (ASA) I to III
- Patient among whom the parents or the legal guardian gave their informed consent
- Patient member in a national insurance scheme
Who cannot join
- Patient presenting a contraindication to general anesthesia
- Patient presenting a contraindication to hypnosis (Chronic Encephalopathy with psychomotor delay, severe cognitive deficit, documented psychiatric disorders)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Perioperative Use of Hypnosis in Pediatric Surgery: Clinical and Medico-economic Interests
In adults, it is common to perform a number of superficial and non invasive surgeries under local anesthesia in order to limit the use of general anesthesia.
Hypnosis is a nonpharmacological therapies that can be used during surgery to improve the patient comfort and experience. The benefit of this practice has been widely demonstrated in adults, decreasing perioperative anxiety, postoperative pain scores as well as nausea and vomiting.
Read more
In pediatric surgery, hypnosis is an effective technique for the management of preoperative anxiety. It is used by many teams in their daily practice, particularly during anesthetic induction.
For 2 years, the team of pediatric anesthesia and surgery of the Montpellier University Hospital also offers for selected short and superficial non-invasive surgeries, an intraoperative management under hypnosis in association with ocal anesthesia as an alternative to general anesthesia. If this clinical practice of hypnosis is fully accepted and recognized in our intraoperative surgical unit, to date, no studies have evaluated the benefits of this technique compared to general anesthesia.
The objective of the study is to compare the impact of these techniques (hypnosis vs. general anesthesia) on postoperative experiences of children (rehabilitation time, anxiety, pain, nausea and vomiting, negative behavioral disorders).
- Conditions
- Minimally Invasive Surgery
- Being tested
- Local anesthetic + Hypnosis, General anesthesia
- Keywords
- Hypnosis, Pediatric surgery, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthetic + HypnosisOther
Modified state of consciousness allowing to be at the same time here and somewhere else. The individual is going to dive into his imagination to extract of an uncomfortable situation. And local anesthetic (solution of Xylocaine with adrenaline 1 % dabbed in 20 % of bicarbonate of sodium 4,2 %, maximal dose of 0,5ml / kg)
General anesthesiaDrug
Sufentanil intravenous (0.1 in 0.2 µg / kg) and propofol (5 in 10 mg / kg on 3 mn) administration
| Study group | Role | What they receive |
|---|---|---|
| 1: General anesthesia | Active comparator | General anesthesia Receives: Drug: General anesthesia |
| 2: Hypnosis | Experimental | Hypnosis with local anesthesia Receives: Other: Local anesthetic + Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to "home readiness"
The time to "home readiness" is defined when a patient is ready for discharge using an evidenced-based discharge scoring criteria.
Measured: up to 4 days
Secondary outcomes (3)
Postoperative pain
Pain is evaluated after surgery and each hour at hospital by the Faces Pain Scale - Revised (FPS-R).
Measured: up to 10 minutes after the entrance to recovery room
Score Induction Compliance Checklist (ICC)
Measured: up to 10 minutes after the entrance to recovery room
Analgesic consumption
Measured: up to 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJun 2015
- Primary completion12 Jan 2018
- Study completion12 Aug 2018
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 Minimally Invasive SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chrystelle CS Sola, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505880
- Sponsor's protocol ID
- 9518
- Other IDs
- 2014-A01776-41
- Status last verified
- Jul 2015
- First submitted
- 15 Jun 2015
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Sola C, Devigne J, Bringuier S, Pico J, Coruble L, Capdevila X, Captier G, Dadure C. Hypnosis as an alternative to general anaesthesia for paediatric superficial surgery: a randomised controlled trial. Br J Anaesth. 2023 Mar;130(3):314-321. doi: 10.1016/j.bja.2022.11.023. Epub 2023 Jan 21.
PubMed 36690538
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perioperative Use of Hypnosis in Pediatric Surgery: Clinical and Medico-economic Interests
- ClinicalTrials.gov ID
- NCT02505880
- Acronym / sponsor ID
- 9518
- Conditions
- Minimally Invasive Surgery
- Keywords
- Hypnosis, Pediatric surgery, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- 12 Jan 2018 (actual)
- Study completion
- 12 Aug 2018 (actual)
- First posted
- 22 Jul 2015 (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.
In adults, it is common to perform a number of superficial and non invasive surgeries under local anesthesia in order to limit the use of general anesthesia.
Hypnosis is a nonpharmacological therapies that can be used during surgery to improve the patient comfort and experience. The benefit of this practice has been widely demonstrated in adults, decreasing perioperative anxiety, postoperative pain scores as well as nausea and vomiting.
In pediatric surgery, hypnosis is an effective technique for the management of preoperative anxiety. It is used by many teams in their daily practice, particularly during anesthetic induction.
For 2 years, the team of pediatric anesthesia and surgery of the Montpellier University Hospital also offers for selected short and superficial non-invasive surgeries, an intraoperative management under hypnosis in association with ocal anesthesia as an alternative to general anesthesia. If this clinical practice of hypnosis is fully accepted and recognized in our intraoperative surgical unit, to date, no studies have evaluated the benefits of this technique compared to general anesthesia.
The objective of the study is to compare the impact of these techniques (hypnosis vs. general anesthesia) on postoperative experiences of children (rehabilitation time, anxiety, pain, nausea and vomiting, negative behavioral disorders).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: General anesthesia | Active comparator | Drug: General anesthesiaGeneral anesthesia |
| 2: Hypnosis | Experimental | Other: Local anesthetic + HypnosisHypnosis with local anesthesia |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patient hospitalized in infantile ambulatory surgery unit
- Patient whose general state corresponds to the classification of the American Society of Anesthesiologists (ASA) I to III
- Patient among whom the parents or the legal guardian gave their informed consent
- Patient member in a national insurance scheme
Key exclusion criteria (2 listed)
- Patient presenting a contraindication to general anesthesia
- Patient presenting a contraindication to hypnosis (Chronic Encephalopathy with psychomotor delay, severe cognitive deficit, documented psychiatric disorders)
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 |
|---|---|---|
| Local anesthetic + HypnosisModified state of consciousness allowing to be at the same time here and somewhere else. The individual is going to dive into his imagination to extract of an uncomfortable situation. And local anesthetic (solution of Xylocaine with adrenaline 1 % dabbed in 20 % of bicarbonate of sodium 4,2 %, maximal dose of 0,5ml / kg) | Other | 2: Hypnosis |
| General anesthesiaSufentanil intravenous (0.1 in 0.2 µg / kg) and propofol (5 in 10 mg / kg on 3 mn) administration | Drug | 1: General anesthesia |
Primary outcome
Time to "home readiness"
Time frame: up to 4 days
The time to "home readiness" is defined when a patient is ready for discharge using an evidenced-based discharge scoring criteria.
3 secondary outcomes
Postoperative pain
Time frame: up to 10 minutes after the entrance to recovery room
Score Induction Compliance Checklist (ICC)
Time frame: up to 10 minutes after the entrance to recovery room
Analgesic consumption
Time frame: up to 24 hours after surgery
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 28 May 2021.
- Derived from this study: PubMed 36690538Sola C, Devigne J, Bringuier S, Pico J, Coruble L, Capdevila X, Captier G, Dadure C. Hypnosis as an alternative to general anaesthesia for paediatric superficial surgery: a randomised controlled trial. Br J Anaesth. 2023 Mar;130(3):314-321. doi: 10.1016/j.bja.2022.11.023. Epub 2023 Jan 21.
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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.
Chrystelle CS Sola, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local anesthetic + Hypnosis and General anesthesia in people with Minimally Invasive Surgery, run by University Hospital, Montpellier 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 4 inclusion and 2 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 28 May 2021. 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?
Time to "home readiness" (time frame: up to 4 days). 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 NCT02505880, 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 28 May 2021.