NCT00938782已完成4 期
A Prospective, Randomized, Double-Blinded Study of the Effect on Improved Recovery Using the SEDLine TM for the Titration of Sevoflurane in Elderly Patients Undergoing Non-Cardiac Surgery After Beta-Adrenergic Blockade
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 3
- 主要终点
- Time to Extubation
研究概览
简要总结
Asses the effect of the use of Patient State Index (PSI) monitoring on difference in emergence profiles in the elderly (age >65 yrs) population to develop a cost-benefit profile.
Assess differences in Quality of Life using the QoR-40 (a validated 40-item questionnaire on quality of recovery from anesthesia) between the two treatment groups.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is male or female.
- •Patient is 65 years of age or older.
- •Patient has a physical status between ASA I and III. (Appendix C).
- •Patient scheduled for general anesthesia for non-cardiac surgery expected to last at least one hour.
- •Patient able to communicate in English.
- •Patient has signed an approved informed consent.
排除标准
- •Patient's age is less than 65 years
- •Anesthetic duration of less than one hour expected
- •Treatment of beta blockers contra-indicated
- •Not a candidate for general anesthesia
- •Patient requires regional anesthesia with general anesthesia.
- •ASA physical status of IV or V. (Appendix C)
- •Patient has known drug or alcohol abuse.
- •Patient has scalp or skull abnormalities such as psoriasis, eczema, angioma, scar tissue, burr holes, cranial implants (such as plates, shunts, etc.).
- •Patient has experienced a head injury with loss of consciousness within the last year.
- •Patient has known neurological and psychiatric disorder that interferes with the patient's level of consciousness.
- •Known concurrent chronic usage of psychoactive or anticonvulsive drugs within the last 90 days, or any use in the last 7 days (i.e. tricyclic antidepressants, MAO inhibitors, lithium, SSRIs, neuroleptics, anxiolytics or antipsychotics).
- •Patient has any medical condition which, in the judgment of the investigator, renders them inappropriate for participation in this study, such as Guillen Bare syndrome
- •Known hypersensitivity to the intended anesthetic agents including significant post-operative nausea or vomiting.
- •Uncontrolled hypertension (unresponsive to medication): Systolic BP > 180 mmHg or Diastolic BP > 105 mmHg
- •Pre-Op baseline heart rate < 45 beats per minute
- •Weight 50% greater than ideal body weight
- •Already monitored for EP or EEG, i.e., Spinal cord cases
- •Actual anesthetic duration < 1 hour (assessed after emergence).
结局指标
主要结局
Time to Extubation
时间窗: Measured from time of end anesthesia to time of tracheal extubation.
The exact time from end of last anesthetic drug to time of tracheal extubation.
次要结局
未报告次要终点
研究者
David R. Drover
Associate Professor
Stanford University
研究点 (3)
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