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Hypnosis Versus General Anesthesia in Pediatric Surgery: Clinical and Medico-economic Interests

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ClinicalTrials.gov Identifier: NCT02505880
Recruitment Status : Unknown
Verified July 2015 by University Hospital, Montpellier.
Recruitment status was:  Active, not recruiting
First Posted : July 22, 2015
Last Update Posted : July 22, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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. 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).


Condition or disease Intervention/treatment Phase
Minimally Invasive Surgery Other: Local anesthetic + Hypnosis Drug: General anesthesia Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: Evaluation of Perioperative Use of Hypnosis in Pediatric Surgery: Clinical and Medico-economic Interests
Study Start Date : June 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Arm Intervention/treatment
Active Comparator: 1: General anesthesia
General anesthesia
Drug: General anesthesia
Sufentanil intravenous (0.1 in 0.2 µg / kg) and propofol (5 in 10 mg / kg on 3 mn) administration

Experimental: 2: Hypnosis
Hypnosis with local anesthesia
Other: Local anesthetic + Hypnosis
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)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Postoperative pain [ Time Frame: up to 10 minutes after the entrance to recovery room ]
    Pain is evaluated after surgery and each hour at hospital by the Faces Pain Scale - Revised (FPS-R).

  2. Score Induction Compliance Checklist (ICC) [ Time Frame: up to 10 minutes after the entrance to recovery room ]
  3. Analgesic consumption [ Time Frame: up to 24 hours after surgery ]


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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient presenting a contraindication to general anesthesia
  • Patient presenting a contraindication to hypnosis (Chronic Encephalopathy with psychomotor delay, severe cognitive deficit, documented psychiatric disorders)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505880


Locations
France
CHRU Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Chrystelle CS Sola, MD Montpellier University Hospital

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02505880     History of Changes
Other Study ID Numbers: 9518
2014-A01776-41 ( Registry Identifier: ID RCB )
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: July 2015

Keywords provided by University Hospital, Montpellier:
Hypnosis
Pediatric surgery
Anesthesia

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents