Nervous System Diseases

Symptoms and General Pathology

All Conditions

Seizures

Neurologic Manifestations

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Dexmedetomidine

Propofol

Remifentanil

Hypnotics and Sedatives

Analgesics, Non-Narcotic

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

Analgesics, Opioid

Narcotics

Awake craniotomy under propofol-remifentanil sedation. Propofol and remifentanyl was administered through continuous intravenous infusion, starting 30 minutes prior to surgery. The end of the infusion was at the end of the surgical procedure.

Propofol dosage: 0.2-2 mk/kg/h Remifentanyl dosage: 0.01-0.1 mcg/kg/min

Awake craniotomy under dexmedetomidine sedation. Dexmedetomidine was administered through continuous intravenous infusion, starting 30 minutes prior to surgery. The end of the infusion was at the end of the surgical procedure.

Dexmedetomidine dosage: 0.2-1 mcg/kg/h In this group, remifentanyl administration was allowed.

awake neurosurgery under propofol-remifentanil sedation

Awake craniotomy require a cooperative patient during resection neurosurgery phase. Anesthesiologist should guarantee analgesia, sedation, nausea and vomiting prevention, while maintaining normal vital parameters.

Neurosurgeon could be help by Intraoperative electrocorticography to maximise lesion resection and avoiding neurologic sequelae. Propofol and remifentanyl have been largely used. Dexmedetomidine represents an alternative. However little is known about the role of dexmedetomidine on Intraoperative electrocorticography.

Propofol-remifentanyl Versus Dexmedetomidine in Awake Craniotomy: Impact on Electroclinical Seizure Activity

Propofol-remifentanil Versus Dexmedetomidine in Awake Craniotomy: an Intraoperative Neurophysiological Evaluation

INCIDENCE OF ELECTRO-CLINICAL SEIZURE ACTIVITY IN THE TWO GROUPS DURING RESECTIVE PHASE OF AWAKE CRANIOTOMY EVALUATED WITH ELECTROCORTICOGRAPHY.

Azienda Sanitaria-Universitaria Integrata di Udine

Principal Investigator

Behaviors and Mental Disorders

Fatigue

Parasomnias

Cognitive Dysfunction

Dyssomnias

Pain

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Sleep Wake Disorders

Quality of Life

In the hypnosis-based intervention, patients (in groups of approximately 10 participants) will participate in 8 weekly sessions (2 hours each) during which they will benefit from guided hypnosis exercises, and learn how to implement self-hypnosis. They will also receive a CD with hypnosis exercises for home practice. At-home practice is encouraged between sessions.

The cognitive trance-based intervention will consist of a two-day workshop in groups of approximately 10 participants, where they will learn how to induce the cognitive trance, with the use of different sound-loops that can induce trance in untrained people in a safe way. After two weeks of home practice, participants will redo a two-day consolidation training. At-home practice is encouraged between sessions.

The meditation-based intervention will consist of 8 weekly sessions (2h45 each) in groups of approximately 10 participants, as well as half a day of intensive practice between the fifth and the sixth session. Participants will learn how to implement self-compassion meditation, through practical exercises proposed during the sessions. At-home practice is encouraged between sessions.

Participants in the control group will not receive any intervention during the whole duration of the study. They will be assessed at the same times and in the same ways than the 3 experimental groups. After the study, they will have the opportunity to participe in one of the 3 interventions if they want to.

Hypnosis group intervention

Cognitive trance group intervention

Meditation group intervention

Audrey Vanhaudenhuyse, PhD

Charlotte Grégoire, PhD

Olivia Gosseries, PhD

Patients with cancer often suffer from a symptom cluster, including pain, fatigue, sleep difficulties, emotional distress and cognitive impairments. In oncology settings, there is a growing interest in "mind-body" intervention, to relieve them in a non-pharmacological way. Hypnosis and meditation are two modified state of consciousness shown to positively this symptom cluster. Cognitive trance is also a modified state of consciousness, but is induced by body movements and/or vocalizations. Subjective reports of experts in cognitive trance showed a modification of self, emotion regulation, pain perception, attention and concentration. However, we still need to develop studies to better characterise this particular state of consciousness and its clinical applications. Our randomized-controlled trial aims at comparing both interventions in terms of (1) benefits on cancer patients' quality of life (pain, fatigue, sleep, distress, cognitive impairments), (2) phenomenological/subjective experiences and neurophysiological correlates, and (3) mechanisms involved in patients' responsiveness, based on the biopsychosocial model of hypnosis.

Cognitive Trance, Hypnosis and Meditation in Oncology

Hypnosis, Meditation and Cognitive Trance on Cancer Patients: Impact on Quality of Life and Neurophysiology

Assessed with a questionnaire (Multidimensional Fatigue Inventory; MFI-20)

Assessed with a visual analogue scale (VAS) (score range from 0 to 10/10, a higher score indicating a higher pain)

Assessed with a questionnaire (Insomnia Severity Index; ISI). Score range from 0 to 28, with a higher score indicating higher sleep difficulties.

Assessed with a questionnaire (Hospital Anxiety and Depression Scale; HADS). Score range from 0 to 42, with a higher score indicating higher emotional distress

Assessed with a questionnaire (FACT-Cog), investigation 4 dimensions (perceived cognitive impairments, score range 0-72, higher score indicating less impairments ; impact of cognitive impairments on quality of life, score range 0-16, with higher scoe indicating less impact ; Comments from others, score range 0-16 with higher score indicating less comments ; perceived cognitive abilities, score range 0-28, with higher score indicating more cognitive abilities)

Assessed with a questionnaire (Multidimensional Psychological Flexibility Inventory; MPFI-24). Score range from 0 to 6 for each dimension (psychological flexibility and psychological inflexibility), with higher score indicating higher flexibility or inflexibility according to the dimension assessed.

Assessed with a questionnaire (Mental adjustment to cancer; MAC). 2 summary scores (Summary positive adjustment, score range from 17 to 68, with higher score indicating higher positive adjustmen ; Summary Negative Adjustment, score ranging from 16 to 64, with higher score indicating highr negative adjustment)

Assessed with a questionnaire (Cognitive Emotion Regulation Questionnaire; CERQ). 2 summary scores (adpative regulation, score ranging from 20 to 100, with higher score indicating higher adaptive regulation ; non-adaptive regulation, score ranging 12-60, with higher score indicating higher non-adaptive regulation)

Assessed with a questionnaire composed of 7 VAS (score from 0 to 10/10, with higher score indicating higher empowerment), based on the Health Education Impact Questionnaire (heiQ)

Assessed with a questionnaire (Big Five Short Form; BFI-10). 5 scales (extraversion, agreeableness, conscientiousness, neuroticism, openness to experience) with score range 1-5, with higher score indicating a stronger presence of this personality trait.

Assessed with a questionnaire designed by our team investigating the previous imaginative experiences of the participant. 25 true/false items. Total score ranging from 0 to 25, with higher score indicating higher level of fantasy proneness.

Assessed with 2 VAS (score range from 0 to 10/10, with higher score indicating higher motivation and higher expectations)

Assessed with a questionnaire (Memory Characteristics Questionnaire; MCQ). Score range from 8 to 104, with higher score indicating higher degree of details about the memory.

Assessed with a questionnaire (Revised Mystical Characteristics Questionnaire; MEQ-30). 4 scales (mystical, score range 0-75, with higher score indicating a more mystical experience ; Positive mood, score range 0-30, with higher score indicating more positive mood during the episode ; Transcendence of time and space, score range 0-30, with higher score indicating stronger trenscendence ; Ineffability, score range 0-15, with higher score indicating higher ineffability)

Assessed with a questionnaire designed by our team to assess the feeling of presence in the imaginative environment linked to the intense memory reported (hypnosis, trance, meditation or personal memory). 2 scales (Presence in the suggested environment and Interaction with others, score range for each dimension 6-42, with higher score indicating higer presence/interaction).

Assessed with a VAS (score range from 0 to 10/10, with higher score indicating better relationship quality).

Assessed with an electroencephalogram (EEG), during resting state and during hypnosis, trance or meditation, according to the chosen intervention. During the EEG, we will also measure the heart rate (with an electrocardiogram), the body temperature, the body movements (with an electromyogram) and the respiration amplitude.

During the EEG, heart rate will be measured (with an electrocardiogram).

During the EEG, body movements will be measured (with an electromyogram).

During the EEG, body temperature will be measured (with a dedicated electrode put on the chest).

During the EEG, respiration (amplitude, effort) will be measured (with a dedicated belts put on the torso)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Propofol-remifentanyl Versus Dexmedetomidine in Awake Craniotomy: Impact on Electroclinical Seizure Activity	NCT05103735	Craniotomy Seizures Dexmedetomidine Propofol Remifentanil Cerebral Tumor Neurophysiology	Propofol	18 Years -	Azienda Sanitaria-Universitaria Integrata di Udine
Cognitive Trance, Hypnosis and Meditation in Oncology	NCT04873661	Cancer Distress, Emoti... Pain Fatigue Sleep Disturban... Cognitive Impai...	Hypnosis group ... Cognitive tranc... Meditation grou...	18 Years -	University of Liege
Propofol-remifentanyl Versus Dexmedetomidine in Awake Craniotomy: Impact on Electroclinical Seizure Activity	NCT05103735	Craniotomy Seizures Dexmedetomidine Propofol Remifentanil Cerebral Tumor Neurophysiology	Propofol	18 Years -	Azienda Sanitaria-Universitaria Integrata di Udine
Cognitive Trance, Hypnosis and Meditation in Oncology	NCT04873661	Cancer Distress, Emoti... Pain Fatigue Sleep Disturban... Cognitive Impai...	Hypnosis group ... Cognitive tranc... Meditation grou...	18 Years -	University of Liege

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