Effect of an Hypnotherapy Session on the NOL Variations After Stimulation

NCT04630717 | Completed

• 1 other identifier: 2021-2446
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose to evaluate the analgesic effect of medical hypnosis prior to the pharmacological induction of general anesthesia versus a classical pharmacological induction of anesthesia. Monitoring of the NOL index (Nociception index) as well as all the other classical parameters under general anesthesia (heart rate, blood pressure etc) will allow evaluation of the level of nociception related to oro-tracheal intubation as well as the one related to standardized electrical tetanic stimulation during general anesthesia and before surgical incision, between the two groups. The investigators know from the literature that the use of medical hypnosis in combination with anesthetic drugs allows for a significant reduction of hypnotic and opioid drugs. The investigators aim here at evaluating the real and objective impact of pre-anesthesia hypnosis on intraoperative nociception by using the NOL index which has been developed and used recently to better detect nociceptive stimuli under anesthesia. This clinical trial will provide an objective answer on the analgesic properties of intraoperative hypnosis. If this is confirmed, hypnosis could find its place in the management of perioperative nociception around general anesthesia.

Conditions

Anesthesia; Hypnosis; Pain

Keywords

Hypnosis; Anesthesia; Pain; Nociception; NOL

Outcome Measures

Primary Outcomes (1)

• Delta NOL (no unit for the NOL index)

  To compare the variation of NOL (delta NOL) after tetanic stimulation under general anesthesia based on hypnosis versus standard care group

  From 1 minute before to 3 minutes after the tetanic stimulation for each patient under general anesthesia

Secondary Outcomes (11)

• Delta Heart Rate (beat per minute)

  From 1 minute before to 3 minutes after the tetanic stimulation for each patient under general anesthesia

• Delta Mean Arterial Blood Pressure (unit:mmHg)

  From 1 minute before to 3 minutes after the tetanic stimulation for each patient under general anesthesia

• Delta BIS (no unit for BIS index)

  From 1 minute before to 3 minutes after the tetanic stimulation for each patient under general anesthesia

• Peak value of NOL (no unit)

  From 1 minute before to 3 minutes after the tetanic stimulation for each patient under general anesthesia

• Area Under the Curve (AUC) for NOL (no unit)

  From T0 (start stimulation) to 3 minutes after tetanic stimulation for each patient

Study Arms (2)

control group

ACTIVE COMPARATOR

normal discussion before general anesthesia induction

Other: control groupe

Hypnosis group

ACTIVE COMPARATOR

hypnosis session before general anesthesia induction

Other: Medical hypnosis session

Interventions

Medical hypnosis session OTHER

the therapist will use a standard and identical protocol in all patients: the International characteristics of the hypnosis protocol are the following hypnotic induction through conversational hypnosis and interviewing about leisure activity. A catalepsy of the hand or the finger will be done, also to stabilize hypnosis if it is accepted by the patient

Hypnosis group

control groupe OTHER

the therapist will use usual voice,loud and strong voice,. clear, high position of the doctor, medical speech focused,no question about the patient's privacy will be made.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA score I, II or III
• Age 18 years or older
• Elective laparoscopic surgery under general anesthesia duration less than 3 hours
• Good understanding of French
• Acceptance of the protocol

You may not qualify if:

• Emergency Surgery
• Pregnant or breastfeeding woman
• Pre-operative hemodynamic failure
• Pathologies of the central nervous system (traumatic sequelae, epilepsy, mental retardation)
• Dependence on drugs or alcohol in the last 6 months
• Consumption of chronic psychotropic drugs for more than 3 months
• Morphine consumption or chronic pain requiring a morphine equivalent of 20 mg po daily for more than 6 weeks.
• Psychiatric pathologies
• Patient Refusal
• Allergy or intolerance to one of the products in the study
• Difficult planned and unplanned intubation
• Unexpected intraoperative complications (circulatory failure, hemorrhage, etc.)

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

CIUSSS de l'Est de l'Ile de Montreal

Montreal, Quebec, H1T2M4, Canada

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Prospective randomized double-blind, single-center trial. The patient does not know whether or not he is in the "hypnotic conversation" group; nor does the anesthesiologist managing the patient intraoperatively knows whether or not the patient had a hypnotic conversation prior to general anesthesia induction.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Model Details: Prospective randomized double-blind, single-center trial. The patient does not know whether or not he is in the "hypnotic conversation" group; nor does the anesthesiologist managing the patient intraoperatively knows whether or not the patient had a hypnotic conversation prior to general anesthesia induction.

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 16, 2020
• Study Start: December 9, 2020
• Primary Completion: December 1, 2021
• Study Completion: March 10, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)