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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Delta NOL (no unit for the NOL index)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.)
结局指标
主要结局
Delta NOL (no unit for the NOL index)
时间窗: From 1 minute before to 3 minutes after the tetanic stimulation for each patient under general anesthesia
To compare the variation of NOL (delta NOL) after tetanic stimulation under general anesthesia based on hypnosis versus standard care group
次要结局
- Time for PACU discharge based on Aldrete score (scale from 0 to 10) (in minutes)(From entrance in PACU until discharge, an average of 2 hours)
- 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)
- Pain Scores (scale from 0 to 10) in PACU(From entrance in PACU until discharge, an average of 2 hours)
- 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)
- Total Dose of Remifentanil (unit: mcg)(Intraoperative])
- Total Dose of Hydromorphone in post-anesthesia care unit (PACU) (unit: mg)(From entrance in PACU until discharge, an average of 2 hours)
- Postoperative nausea and vomiting (PONV) score (scale from 0 to 3) in PACU(From entrance in PACU until discharge, an average of 2 hours)
- Pasero Opioid-Induced Sedation Scale (POSS score) (scale from 1 to 4) in PACU(From entrance in PACU until discharge, an average of 2 hours)
研究者
Philippe Richebe
MD, PhD, Professor
Ciusss de L'Est de l'Île de Montréal