Overview

This trial is active, not recruiting.

Condition minimally invasive surgery
Treatments local anesthetic + hypnosis, general anesthesia
Sponsor University Hospital, Montpellier
Start date June 2015
End date September 2017
Trial size 60 participants
Trial identifier NCT02505880, 2014-A01776-41, 9518

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (caregiver)
Primary purpose supportive care
Arm
(Active Comparator)
General anesthesia
general anesthesia
Sufentanil intravenous (0.1 in 0.2 µg / kg) and propofol (5 in 10 mg / kg on 3 mn) administration
(Experimental)
Hypnosis with local anesthesia
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 Outcomes

Measure
Time to "home readiness"
time frame: up to 4 days

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 7 years up to 16 years old.

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)

Additional Information

Official title Evaluation of Perioperative Use of Hypnosis in Pediatric Surgery: Clinical and Medico-economic Interests
Principal investigator Chrystelle CS Sola, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by University Hospital, Montpellier.