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Unconsciousness clinical trials

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NCT ID: NCT02747680 Completed - Healthy Clinical Trials

Cerebral Responses to Insulin Induced Hypoglycemia

1018
Start date: January 2004
Phase: N/A
Study type: Interventional

This research study is designed to investigate the effect of hypoglycemia (low blood sugar) on blood flow to and biochemistry in the brain.

NCT ID: NCT02700048 Terminated - Type 1 Diabetes Clinical Trials

Intra-nasal Naloxone for Treatment of Impaired Awareness of Hypoglycemia

Start date: June 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single center, single-blind randomized cross over design trial that will compare the impact of intra-nasal naloxone vs. intra-nasal saline administration during experimental hypoglycemia on day one on responses to experimental hypoglycemia on day two. Investigators intend to enroll 18 individuals to obtain the complete data sets from 15 participants. Expected duration of subject participation is 10-12 weeks. This study will consist of two 2-day intervention visits separated by approximately 8 weeks.

NCT ID: NCT02624401 Completed - Anesthesia Clinical Trials

The Neural Mechanisms of Anesthesia and Human Consciousness (Part 6)

Start date: January 2016
Phase: Phase 4
Study type: Interventional

Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI) and electroencephalography (EEG) studies will be carried out to reveal the neural correlates of consciousness. Consciousness of the subjects will be manipulated with anesthetic agents dexmedetomidine, propofol, S-ketamine and sevoflurane. One-hundred-and-sixty (160) healthy male subjects will be recruited to receive EC50 concentration of the anesthetic (40 dexmedetomidine, 40 propofol, 20 S-ketamine, 40 sevoflurane) or placebo (20) while being imaged for cerebral metabolic rate of glucose (CMRglu). Also genetic, immunological and metabolomics samples will be taken and analysed to find possible genetic factors explaining the variability in drug response and to find chemical fingerprints of acute drug effect.

NCT ID: NCT02589223 Terminated - Clinical trials for Traumatic Brain Injury With Prolonged Loss of Consciousness

A Trial to Determine the Feasibility and Effectiveness of Early Multisensory Stimulation Intervention in Patients in the Trauma-Neurosurgical Intensive Care Unit (TNICU) Following Severe Acquired Brain Injury

Start date: February 16, 2017
Phase: N/A
Study type: Interventional

St. Michael's Hospital (SMH) provides service to individuals with some of the most severe brain injuries and intensive care needs in Canada. These patients often require prolonged intensive care admissions, lengthy hospital stays, involvement of many health professionals, and long-term support for ongoing care requirements. Many hospitals face resource limitations, specifically involving the health disciplines and their ability to provide frequent intervention. It has been proposed that multisensory stimulation (i.e. exposing the patient to various sights, sounds, smells, etc.) in the early stages of brain injury recovery may result in improved responsiveness/cognitive function. Previous research has indicated a potential benefit for early multisensory stimulation intervention for patients with severe brain injury. However there is still not enough conclusive evidence to confirm whether the intervention is truly effective. The investigators are proposing a pilot randomized controlled study (placebo-controlled, double-blinded) to determine the feasibility and examine the effectiveness of early multisensory stimulation with patients following severe brain injury who remain in a coma, vegetative state, or minimally conscious state. Eligible patients will be randomized to a control group (standard care + family/caregiver education) or an intervention group (standard care + family/caregiver education + early sensory intervention). Data regarding number of patients enrolled, amount of intervention completed, percentage of outcome data collected, patient's level of responsiveness and cognitive function will be collected before and after the intervention period, using several outcome measures. The investigators hope to determine the feasibility of conducting this type of study within this clinical setting and the effectiveness of multisensory stimulation with this patient population.

NCT ID: NCT02536690 Completed - Anesthesia Clinical Trials

Remifentanil and Midazolam on Propofol for Loss of Consciousness

Start date: August 2015
Phase: N/A
Study type: Interventional

Propofol in combination with remifentanil or midazolam can result in synergistic or additive effect. The patients who are scheduled to undergo general anesthesia are enrolled in this study. 120 patients will be randomly allocated to 3 groups(P, PR, PMR). The patients in group P will receive general anesthesia only with propofol and group PR and PMR will receive 0.25 mcg/kg/min remifentanil infusion prior to propofol. The patients in group PMR will receive 0.03 mg/kg bolus dose of midazolam 1 min after start of the remifentanil infusion. 'Success' is defined as loss of both verbal response and eyelash reflex in 2 min after propofol administration. When 'success', the next patient will receive the same dose(in 18/19 probability) or 0.25 mg/kg lower dose(in 1/19 probability) of propofol. When 'failure', the next patient will receive 0.25 mg/kg higher dose of propofol at induction period.

NCT ID: NCT02520947 Completed - Unconscious State Clinical Trials

The Effect of BIS Monitorization to Intraoperative Anesthetic Consumption During Coronary Artery Surgery

Start date: January 2014
Phase: N/A
Study type: Interventional

213 patients undergoing elective on-pump coronary artery bypass grafting (CABG) were enrolled into this prospective-clinical trial.After hundred and sixty three patients were excluded due to various reasons, 50 patients were randomized to BIS (bispectral index) and MAC (minimum alveolar concentration) groups. In BIS group (Group B, n=25), desflurane was titrated within 40 to 60 BIS values and in MAC group (Group M, n=25) within 0.7 to 1.3 MAC. Primary end point of the study was to investigate the difference of desflurane consumption between groups.

NCT ID: NCT02429960 Completed - Anesthesia Clinical Trials

Comparison of Different Analgesia-Monitors in Tracing Unconscious Pain Sensations

AMUPS
Start date: April 2015
Phase: N/A
Study type: Interventional

Until today there is no standard-monitoring to specifically reflect the analgesic component of general anesthesia. Quality and safety of general anesthesia are of major clinical importance and can be improved by limiting the administration of opioid analgesics to the minimum dose needed. This study therefore examines the quality of three different monitoring techniques (PhysioDoloris, MetroDoloris, Lille, France, SPI (Surgical Plethysmographic Index), GE Healthcare, Helsinki, Finland and AlgiScan, IDMed, Marseille, France) in assessing the level of analgesia during general anesthesia. Therefore a standardized painful stimulus is applied under different levels of analgesic drugs. The monitor's indices are compared to clinical signs such as an increase in heart rate and blood pressure.

NCT ID: NCT02308293 Completed - Clinical trials for Type 1 Diabetes Mellitus

The Role of Endogenous Lactate in Brain Preservation and Counterregulatory Defenses Against Hypoglycemia

Start date: January 2015
Phase: N/A
Study type: Interventional

Iatrogenic hypoglycemia is the most frequent acute complication of insulin therapy in people with type 1 diabetes (T1DM). Recurrent hypoglycemic events initiate a process of habituation, characterized by suppression of hypoglycemic symptoms, eventually leading to hypoglycemia unawareness, which creates a particularly high risk of severe hypoglycemia. Recent evidence suggest a pivotal role for (brain) lactate in the pathogenesis of hypoglycemia unawareness. Indeed, exogenous lactate administration may preserve brain function and attenuate counterregulatory responses to and symptomatic awareness of hypoglycemia. It is unknown whether endogenous elevation of plasma lactate produces the same effects and whether such effects differ between patients with T1DM with and without hypoglycemia unawareness and healthy controls. Objective: To investigate the effect of elevated levels of endogenous lactate on brain lactate accumulation and on counterregulatory responses to, symptomatic awareness of and cognitive function during hypoglycemia in patients with T1DM with and without hypoglycemia unawareness and normal controls. Hypothesis: The investigators hypothesize first that endogenous lactate, when raised through high intensity exercise, preserves neuronal metabolism during subsequent hypoglycemia, which in turn will attenuate counterregulatory hormone responses, appearance of symptoms and deterioration of cognitive function. Second, the investigators posit that these effects will be augmented in patients with hypoglycemia unawareness compared to healthy subjects and T1DM patients with normal awareness as a consequence of greater transport capacity of lactate into the brain.

NCT ID: NCT02287181 Completed - Clinical trials for Induction of Anaesthesia

A Phase IV Study Investigating the Effects of Remifentanil Concentrations on Propofol Requirements for Loss of Consciousness, Response to Painful Stimuli, Bispectral Index and Associated Haemodynamic Changes

Start date: February 2015
Phase: Phase 4
Study type: Interventional

A prospective, randomised, phase IV trial including 150 patients. To evaluate the effects of varied concentrations of remifentanil on the proposal requirements for the loss of consciousness and response to pain and to evaluate the haemodynamic changes and processed EEG (BIS) during induction of anaesthesia.

NCT ID: NCT02282254 Completed - Type 1 Diabetes Clinical Trials

Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Type 1 Diabètes Adults With Hypoglycemia Unawareness and Documented Nocturnal Hypoglycemia

Start date: October 2014
Phase: Phase 2
Study type: Interventional

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop strategy would regulate glucose levels through the infusion of two hormones: insulin and glucagon. The main objective of this project is to compare the efficacy of single-hormone and dual-hormone closed-loop strategy to regulate overnight glucose levels in a in-patient study in type 1 diabetes adults with hypoglycemia unawareness and documented nocturnal hypoglycemia. The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating overnight glucose levels compared to single-hormone closed-loop strategy.