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Elective Surgery clinical trials

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NCT ID: NCT00948597 Completed - Obesity Clinical Trials

Development of PK/PD Model for Individualized Propofol Dosing

Start date: July 2009
Phase: N/A
Study type: Observational

The U.S. National Health and Nutrition Examination Survey of 1994 indicated that 59% of American men and 49% of women have body mass indexes (BMIs) over 25. Extreme obesity, defined as a BMI of 40 or more, was found in 2% of the men and 4% of the women [http://www.cdc.gov/nchs/nhanes.htm]. The newest survey in 2007 indicates an alarming increase in BMI; 63% of Americans are overweight, with 26% now in the obese category. With extreme obesity as high as 26-30% in adults, obesity percentages in children are also sharply on the rise. These alarming numbers pose a major clinical problem in terms of the safe and effective use of drugs in children. Obesity may alter the disposition and/or clearance of drugs in the body as well as the response, which should be considered when using anesthetics in these patients. Total intravenous anesthesia (TIVA) with propofol is widely used in children, adolescents and adults undergoing surgery, because of rapid onset of action, ease of titration and rapid offset of action. While extensive research on optimal propofol dosing has been performed in non-obese adults, including in critically ill mechanically ventilated adult patients by the investigators' collaborators, there is no evidence on required dosages in morbidly obese adult or pediatric patients of this highly lipophilic agent. As a consequence, serious problems do arise due to under- and overdosing, increasing the risk of inadequate effects and adverse events, respectively. Crucial additional information is needed on the pharmacokinetics of drugs used in morbidly obese children to improve safety and efficacy. This proposal will test a novel approach by identifying pharmacokinetic/pharmacodynamic (PK/PD) factors that are associated with response to therapy and adverse events. If successful, this study will provide proof of concept data for PK/PD model-based dosing strategy that can be implemented into daily clinical care to allow tailoring of dose to individual needs. Propofol is a versatile anesthetic agent which if dosed to individual needs based on a patient's characteristics and specific PK/PD parameters, will allow individualized dosing, thereby greatly reducing related toxicities. The prospective identification of predictive factors in these morbidly obese high-risk patients represents a new approach to an increasingly common clinical problem. The investigators expect that this study will generate the PK/PD data necessary to continue with a well powered prospective clinical trial.

NCT ID: NCT00875134 Completed - Clinical trials for Respiratory Depression

Testing of the Apnea Prevention Device

Start date: March 2009
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed to test the ability of a computer-based algorithm to detect and intervene in cases of narcotic-induced respiratory depression.

NCT ID: NCT00795392 Completed - Elective Surgery Clinical Trials

Preoperative Psychological Evaluation as Predictor of Outcomes

PEPO
Start date: November 2008
Phase: N/A
Study type: Observational

Perioperative psychological care is increasingly recognized as an essential part in the surgical environment. Previous studies have developed a strategy to evaluate the psychological influence after operations and found that postoperative psychological states significantly associated with the outcomes of patients. However, preoperative evaluation of patients the physicians do thus far is mainly the physical status assessment following the scale of American Society of Anesthesiologists (ASA). Whether a full-scale evaluation of preoperative psychological status to surgical patients could be a predictor to postoperative outcomes or not is not still completely understood. The investigators hypothesized that the preoperative psychological assessment would be an important predictor to outcomes.

NCT ID: NCT00776880 Completed - Elective Surgery Clinical Trials

Does American Society of Anesthesiologists (ASA) Physical Status Scale Enough in Patients Assessment

ASAINPA
Start date: January 2009
Phase: N/A
Study type: Observational

American Society of Anesthesiologists (ASA) physical status scale has been used worldwide for assessing the status of patients before operation. However, merely the value of ASA scale did not give enough information of patients to determine their prognosis and improvement of outcomes. Since 1948, World Health Organization (WHO) defined health as the state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. Therefore, the investigators hypothesized that the ASA scale only was needed to be modified and should be replaced by a comprehensive gauge to evaluate the status of patients in depth. Based on this thought, the investigators used a new system, i.e., physical-psycho-social (PPS) scale, to assess the overall state before surgical procedures.

NCT ID: NCT00290108 Completed - Healthy Clinical Trials

The Influence of Injection Rate on EEG Propofol Peak Effect as Measured by Bispectral Index

Start date: March 2003
Phase: N/A
Study type: Interventional

The aim of the present study was to investigate whether injection rate of propofol has an influence on its maximum effect.

NCT ID: NCT00205244 Completed - Anxiety Clinical Trials

Preoperative Preparation for Children

Start date: February 17, 2004
Phase: N/A
Study type: Interventional

Children scheduled for elective surgery are randomized into a control and intervention group. Children in the intervention group receive a CD and booklet of relaxation and distraction stories to listen to/read during the preoperative period. Preoperative anxiety is assessed by the child life specialist in the preoperative holding area. Ease of induction and emergence from anesthesia are rated by the anesthesia care provider. Post-hospital behaviors are reported by the parents one week after discharge. It is hypothesized that children receiving the intervention will have less anxiety, easier induction and emergence from anesthesia, and fewer changes in post-hospital behaviors than children in the control group.