Anesthesia: Anesthesia is characterized by unconsciousness resulting from the administration of a general anesthetic, to facilitate very painful procedures. Apart from the loss of consciousness, also pain perception, defensive reflexes as well as muscle tension are thereby inactivated throughout the body.
Anesthetic: A drug which effects anesthesia/narcosis.
ASA classification: The ASA physical status classification system is a system for assessing the fitness of cases before surgery. In 1963 the American Society of Anesthesiologists(ASA) adopted the five-category physical status classification system; a sixth category was later added. These are:
1. Healthy person 2. Mild systemic disease 3. Severe systemic disease 4. Severe systemic disease that is a constant threat to life 5. A moribund person who is not expected to survive without the operation 6. A declared brain-dead person whose organs are being removed for donor purposes.
Clinical Phase I: In clinical Phase I studies, drug candidates are explored in healthy volunteers (so-called probands). The main focus of these studies is usually safety and tolerability. Moreover, the concentration of the substance in the blood is typically being determined, among other parameters. Interaction with other drugs is also frequently studied. Potential participants freely decide about inclusion in Phase I studies after being informed about scope, risks and the study protocol.
Clinical Phase II: In clinical Phase II studies, drug candidates are for the first time therapeutically evaluated in patients. A successful Phase II thus is considered a major step forward regarding the commercial valuation of the drug and the company developing it. Phase II studies mainly focus on finding the right dose for effective therapy. While statistical significance usually is achieved through larger scale Phase III studies, Phase II studies often give important indications whether the drug candidate can meet expectations. In most cases, if major side effects exist, they will be discovered in Phase II. Potential participants or their relatives, respectively, freely decide about inclusion in Phase II studies after being informed about scope, risks and the study protocol.
Clinical Phase III: Clinical Phase III studies concentrate on showing efficacy in a statistically significant manner with an acceptable safety profile. In Phase III and sometimes already in Phase II, studies are normally carried out as doubleblind, placebo-controlled trials. “Placebo control" refers to the fact that one sub-group of patients receives only an inactive substance (placebo). As neither the patient nor the physician knows who received drug candidate or placebo, these studies are dubbed “double-blind". Through this study design, one can rule out that measured effects are due to other factors than the drug candidate. Potential participants or their relatives, respectively, freely decide about inclusion in Phase III studies after being informed about scope, risks and the study protocol. After successful completion of Phase III, the next step is usually filing for regulatory approval.
Clinical studies: Well-controlled assessment of the effects of drug candidates or new medical devices.
General anesthesia: General anesthesia leads to loss of consciousness and loss of sensation of patients through the administration of anesthetics in combination with opioid analgesics. This enables medical procedures such as major surgery, that would otherwise be unbearable, to be carried out with minimal discomfort or added risk.
GGF2 Glial Growth Factor 2; known to stimulate the growth and differentiation of a variety of cells including glial cells, the support cells of the nervous system. These glial cells form the myelin sheath that insulates nerve cells and is essential for their survival and proper functioning. In demyelinating diseases such as multiple sclerosis, the myelin sheath is damaged, leading to the degeneration of nerve cells.
INN (international non-proprietary name): The non-proprietary or generic name given to a pharmaceutical substance by the World Health Organisation (WHO). Whereas many substances are distributed under different trade names, INNs are internationally uniform and thereby facilitate a clear distinction. In contrast to internal substance names used by companies (eg CNS 7056), it is custom to use the INN in scientific publications (ie Remimazolam).
Morphine-6-Glucuronide (M6G): A highly potent opiate which may offer therapeutic advantages over morphine, the current gold standard for the treatment of moderate to severe post-operative pain, in having an equivalent analgesic effect, but with a reduced tendency to cause side-effects such as nausea and vomiting.
Narcotic: A drug which effects anesthesia/narcosis.
Opiate: Any of various sedative narcotics containing opium or one or more of its natural or synthetic derivatives.
Peri-operative pain: Pain experienced during and/or after an operation, originating from the surgery.
Placebo Inactive substance: In clinical studies, one patient group receives an inactive substance (placebo) instead of the drug candidate in order to rule out that effects are caused by other factors than the drug.
Pre-clinical research: Laboratory tests of a new drug candidate or a new medical device on animals or cell cultures. These tests are conducted to explore the mode of action as well as to detect potential risks prior to testing in humans.
Proband: Volunteer (Phase I studies)
Procedural sedation: Procedural sedation is a technique of administering sedatives or dissociative agents, with or without analgesics, to induce a state that allows the patient to tolerate unpleasant procedures such as colonoscopy while maintaining cardiorespiratory function.
Remimazolam: Remimazolam is an ultra short-acting intravenous sedative and anesthetic in Phase III clinical development. It is a member of the class of substances known as benzodiazepines. In the human body, Remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases, and not metabolized by hepatic or renal pathways. Like other benzodiazepines, Remimazolam can be reversed with flumazenil.
Sedation: Reduction of anxiety, stress, irritability, or excitement by administration of a sedative to facilitate a medical procedure.
Sedative: A drug which generally promotes sedation.