Effect of an Hypnotherapy Session on the NOL Variations After Stimulation

Pain Clinical Trial

— HYPNOSTIMNOL  

Official title:

Effect of an Hypnotherapy Right Before the Induction of Anesthesia Versus Standard Induction on NOL Variations After Standardized Stimulation Performed Under General Anesthesia The HYPNOSTIMNOL Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04630717
• Other study ID #: 2021-2446
• Status: Completed
• Phase: N/A
• Start date: December 9, 2020
• Est. completion date: March 10, 2022

Study information

• Verified date: March 2022
• Source: Ciusss de L'Est de l'Île de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Study Design: Prospective randomized double-blind, mono-centric trial (patient does not know if the conversation is hypnotic or not, the anesthesiologist in charge during the case is not here during the preoperative conversation and is not the one doing the medical conversational hypnosis or standard conversation).

This study proposes to answer two questions :

• To measure the difference in the variation of the NOL index (delta NOL) after standardized electrical stimulation performed after tracheal intubation under general anesthesia between two types of anesthetic induction : pharmacological induction associated with a brief session of medical hypnosis versus a standard pharmacological induction.

• To measure variation of heart rate, arterial pressure, BISpectral index after intubation, standardized electrical stimulation, incision and other intraoperative surgical stimuli. Evaluation of postoperative pain, analgesic consumption in the recovery room, and recovery room discharge time.

50 Adults scheduled for elective laparoscopic surgery under general anesthesia expected to last less than 3 hours will be enrolled.

Patients will be informed and included the day before surgery. Randomization will be done by web-base-systeme-algorithm dividing patients into two groups: general anesthesia alone or general anesthesia coupled with hypnosis. No premedication will be administered.

The hypnotherapist will meet briefly with the patient before admission to the operating room to introduce himself.

When the patient enters the operating room, a checklist is performed by the staff, the usual monitoring is set up (electrocardiogram, pulse oximeter, non-invasive blood pressure, muscle relaxation monitor, bispectral index, NOL index). Nasoparyngeal temperature and monitoring of expired carbon dioxide will be placed following tracheal intubation to allow monitoring of normothermia and normo capnia intraoperatively.

The PMD200TM monitor and the BIS index will be connected to the patient. Registration of the index NOL will be done continuously via the PMD200TM monitor, which will be switched on at the start of the procedures.

When everything is ready for pharmacological induction the anesthesiologist in charge will leave the operating room.

In the control arm the therapist will have a standard discussion to check all things are all right with the patient before pharmacological induction starts. No hypnotic conversation will be proposed.

In the hypnosis arm a short session of hypnosis will be done before the pharmacological induction.

The period of discussion in both the groups will be between 6 and 15 minutes, hypnotic or not.

Then, the anesthesiologist will be called for pharmacological induction of general anesthesia.

The protocol of anesthesia will be the same in both groups : the induction will be done by propofol (with a goal of Bispectral index : 40-60) and Remifentanil (with goal of NOL < 25), and muscle relaxation with Rocuronium (0.8 mg.kg-1).

After tracheal intubation, the remifentanil will be discontinued. After a period of at least 10 minutes after remifentanil discontinuation, a standardized tetanic stimulation (70mA, 100Hz, 30 seconds at the ulnar level) will be applied and all the anesthesia parameters and NOL index will be electronically recorded every 5 seconds.

After this stimulation, general anesthesia will be maintained as follows: sevoflurane inhaled anesthesia for a bispectral index between 40-60; remifentanil analgesia for a NOL index between 5-25; rocuronium for a muscle relaxation with TOF index between 1-3. Total consumption of remifentanil during the case will be monitored and calculated in mcg.kg-1 per hour of surgery as it will be a surrogate of intraoperative pain/nociception that will be analyzed too. At the end of surgery, anesthesia is discontinued, hydromorphone 7mcg.kg-1 will be administered at the end of skin closure in anticipation of postoperative pain. Acetaminophen will also be given PR at the end of surgery as well as intravenous ketorolac. Skin incisions for laparoscopic surgery will be infiltrated with 0.5% bupivacaine (maximum 20mL). Once the patient extubated, she/he will be transferred to post anesthesia care unit (PACU) where classical pain management will be offered. Pain scores in PACU, patients' satisfaction, opioid consumption will be evaluated between the two groups in PACU.

Data analysis: The main outcome analyzed will be the delta NOL or the variation of the NOL index between pre and post stimulation in the two groups. The mean maximum value of the NOL index after stimulation will also be compared between the two groups.

Statistical analyses will be performed using SAS version 9.4 or higher and will be performed at a bilateral significance level of 0.05, unless otherwise specified. Descriptive statistics of central tendency (e.g., mean and 95% CI, median) and dispersion (SD, frequency table) will be used to describe the characteristics of the patients in each group of the study. The intraoperative data collected in the groups will be compared using parametric (e.g. Student's t-test) or non-parametric (e.g. Mann-Withney's U-test, Chi-square test) tests depending on the type of variables and their distribution.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 10, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Exclusion criteria :

• Difficult planned and unplanned intubation

• Unexpected intraoperative complications (circulatory failure, hemorrhage, etc.)

Related Conditions & MeSH terms

• Anesthesia
• Hypnosis
• Pain

Intervention

Other:
• Medical hypnosis session
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
• control groupe
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.

Locations

Country	Name	City	State
Canada	CIUSSS de l'Est de l'Ile de Montreal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Ciusss de L'Est de l'Île de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Delta Heart Rate (beat per minute)	To compare the variation of heart rate (HR) 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	Delta Mean Arterial Blood Pressure (unit:mmHg)	To compare the variation of mean arterial blood pressure (MABP) 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	Delta BIS (no unit for BIS index)	To compare the variation of bispectral index (BIS) 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	Peak value of NOL (no unit)	To compare the peak value of 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	Area Under the Curve (AUC) for NOL (no unit)	To compare the AUC of NOL after tetanic stimulation under general anesthesia based on hypnosis versus standard care group	From T0 (start stimulation) to 3 minutes after tetanic stimulation for each patient
Secondary	Total Dose of Remifentanil (unit: mcg)	Total dose of remifentanil in mcg from induction of anesthesia until tracheal extubation	Intraoperative]
Secondary	Total Dose of Hydromorphone in post-anesthesia care unit (PACU) (unit: mg)	Total dose of hydromorphone (mg) in PACU	From entrance in PACU until discharge, an average of 2 hours
Secondary	Pain Scores (scale from 0 to 10) in PACU	Maximum Pain scores in PACU	From entrance in PACU until discharge, an average of 2 hours
Secondary	Postoperative nausea and vomiting (PONV) score (scale from 0 to 3) in PACU	PONV score on a scale from 0 (none nausea and vomiting ) to 3 (maximum nausea and vomiting ) in PACU	From entrance in PACU until discharge, an average of 2 hours
Secondary	Pasero Opioid-Induced Sedation Scale (POSS score) (scale from 1 to 4) in PACU	POSS score on a scale from 1 (sleep, easy to arouse ) to 4 (somnolent, minimal or no response) in PACU	From entrance in PACU until discharge, an average of 2 hours
Secondary	Time for PACU discharge based on Aldrete score (scale from 0 to 10) (in minutes)	Time (in minutes) for readiness for PACU discharge based on Aldrete score greater than or equal to 9	From entrance in PACU until discharge, an average of 2 hours