Inhaled Sevofluran vs Endovenous Propofol for Sedation Maintenance in Patients Submitted to Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Heart rate
研究概览
简要总结
To compare the anesthetic efficacy of the inhalation versus intravenous technique for maintenance of sedation in patients undergoing endoscopy.
A longitudinal, randomized clinical study of 32 patients of both sexes ASA I-III, aged 18-80 years undergoing diagnostic colonoscopy, which was randomly divided into 2 groups. In both, intravenous induction with propofol (2-2.5 mg / kg) was performed, Group A remained sedated with propofol infusion (1-2 mg / kg / min); Group B by inhalation with sevoflurane at a concentration of 2 vol% through a nasal cannula with an oxygen flow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years
- •physical status I, II and III according to the criteria of the American Society of Anesthesiology (ASA)
- •patients who are going to undergo diagnostic colonoscopies
- •patients who signed the informed consent
排除标准
- •Allergy or hypersensitivity to some of the reference drugs in the study
- •patients with proven liver disease
- •suspicion or confirmation of pregnancy
- •antecedent or risk of malignant hyperthermia
- •fasting less than 8 hours
- •patients with psychic disorders or mental incapacity that make it difficult to understand their participation in the study
- •patients who have acute illnesses that compromise their health for which the study cannot be performed
研究组 & 干预措施
Group Propofol
propofol infusion
干预措施: Propofol (Drug)
Group Sevoflurane
inhalation with sevoflurane
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Heart rate
时间窗: During the colonoscopy - an estimated mean time of 20 minutes
heart rate per minute
The Recovery Time
时间窗: 30 min
Every 5 minutes till a score of 10/10 achieved on Aldrete Score
Propofol dosage
时间窗: During the colonoscopy - an estimated mean time of 20 minutes
propofol rescate bolus administered
arterial pressure
时间窗: During the colonoscopy - an estimated mean time of 20 minutes
non invasive arterial pressure every 5 minutes
oxygen saturation
时间窗: During the colonoscopy - an estimated mean time of 20 minutes
pulse oximetry
次要结局
- Qualitatively assess patient comfort after sedation.(Up to 1 hour after completing the study.)
- adverse reactions in patients(1 day (postoperative))
- Endoscopist Satisfaction(60 min)
研究者
Leopoldo Wulff
Principal Investigator, anesthesiologist.
Centro Medico Docente la Trinidad