A Comparison of Post-operative Recovery Between Remifentanil-propofol and Remifentanil-desflurane Anesthesia Guided by Bispectral Index Monitoring
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Extubation Time
研究概览
简要总结
Bispectral monitoring anesthesia with remifentanil-desflurane has a better post-operative recovery than remifentanil-propofol.
详细描述
It is a randomized, double blind study, involving 40 adult female patients submitted to general anesthesia. The patients were distributed into 2 groups: remifentanil-propofol-based anesthesia and remifentanil-desflurane-based anesthesia groups. Bispectral index (BIS) monitoring guided the anesthesia by setting target BIS range value between 40 and 60. Anesthetics were adjusted to reached that. Primary outcome was: extubation time (time from anesthetic discontinuation to endotracheal tube cuff). Secondary measured outcomes: intra-operative cardiovascular drug use; time to follow command before extubation; protective airway reflex recovery time after extubation. Protective airway reflex test recovery was performed at predetermined time intervals (2, 6, 14, 22 and 30 minutes) from the time to follow a standard command until the first demonstrated ability to swallow 20 ml of water in an upright position.Post-anesthesia care unit recovery data were also recorded: Ramsay sedation scale; vital signs, post-operative pain; morphine consumption.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients over 18 years old classified by the American Society of Anesthesiologists as physical status I or II, undergoing elective breast surgery with general anesthesia.
排除标准
- •History of: illegal drug and alcohol abuse
- •Pregnancy on course or suspicion of
- •Neuromuscular disorders
- •Cerebral vascular disease
- •Dysphagia
- •Dysphonia
- •Gastroesophageal reflux disease
- •Previous larynx and/or upper gastrointestinal tract surgery
- •Allergy to any drug to be used and malignant hyperthermia.
- •Patients who develop hemodynamic instability in the surgery and need blood transfusion were excluded from the study.
- •Patients unable to swallow 20 ml of water in an upright position were also excluded.
研究组 & 干预措施
REM-PRO
Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models.
干预措施: Propofol (Drug)
REM-DES
Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane.
干预措施: Desflurane (Drug)
结局指标
主要结局
Extubation Time
时间窗: Time from anesthetic discontinuation to endotracheal tube cuff deflation
Time from anesthetic discontinuation to endotracheal tube cuff deflation
次要结局
未报告次要终点
研究者
Renato Santiago Gomez
Head of surgery department of the Medical School of the Federal University of Minas Gerais
Federal University of Minas Gerais