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

NCT02505880 | Completed

• 2 other identifiers: 95182014-A01776-41
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Minimally Invasive Surgery

Keywords

Hypnosis; Pediatric surgery; Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 4 days

Secondary Outcomes (3)

• Postoperative pain

  up to 10 minutes after the entrance to recovery room

• Score Induction Compliance Checklist (ICC)

  up to 10 minutes after the entrance to recovery room

• Analgesic consumption

  up to 24 hours after surgery

Study Arms (2)

1: General anesthesia

ACTIVE COMPARATOR

General anesthesia

Drug: General anesthesia

2: Hypnosis

EXPERIMENTAL

Hypnosis with local anesthesia

Other: Local anesthetic + Hypnosis

Interventions

Local anesthetic + Hypnosis OTHER

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)

2: Hypnosis

General anesthesia DRUG

Sufentanil intravenous (0.1 in 0.2 µg / kg) and propofol (5 in 10 mg / kg on 3 mn) administration

1: General anesthesia

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHRU Montpellier

Montpellier, 34295, France

Location

Related Publications (1)

• 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.

  PMID: 36690538 DERIVED

MeSH Terms

Interventions

Anesthetics, Local; Hypnosis; Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Anesthesia; Anesthesia and Analgesia

Study Officials

• Chrystelle CS Sola, MD

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: July 22, 2015
• Study Start: June 1, 2015
• Primary Completion: January 12, 2018
• Study Completion: August 12, 2018
• Last Updated: May 28, 2021

Record last verified: 2015-07

Locations

FR (1)