Efficacy of Propofol Combination With Either Ketamine, Dexmedetomidine or Midazolam for Sedation During Upper Gastrointestinal Endoscopic Procedures: A Prospective, Randomized, Comparative Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Induction time
研究概览
简要总结
The investigators are comparing the efficacy of three different sedative agents in gastrointestinal endoscopic procedures.
详细描述
The investigators aim to compare the efficacy of ketamine-propofol, dexmedetomidine-propofol, and midazolam-propofol combinations as procedural sedative agents for adult patients undergoing elective upper gastrointestinal endoscopic procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both male and female patients aged between 18 and 65 years
- •Patients who are scheduled for elective upper gastrointestinal endoscopic procedures with sedation
- •Patients who are classified as ASA (American Society of Anesthesiologists) I and II
排除标准
- •Patient's refusal to participate
- •Respiratory compromise as patients with respiratory failure or with active chest conditions, e.g., bronchial asthma or pneumonia
- •Cardiovascular compromise including heart failure and shocked patients
- •Severe uncontrolled hematemesis with shock or risk of aspiration.
- •Patients who are allergic or have any contraindications to any of the used drugs.
- •Patients who have a chronic neuropsychiatric disorder or are on a neuropsychiatric drug.
- •Patients on long-term sedative medication have a history of drug or alcohol abuse.
- •Pregnancy and lactation
研究组 & 干预措施
Group 1
Dexmedetomidine (200 µg/2ml vial) + Propofol (1% 20 mls ampoule)
干预措施: Dexmedetomidine and propofol (Drug)
Group 2
Ketamine (50mg/1ml vial) + Propofol (1% 20 mls ampoule)
干预措施: ketamine and propofol (Drug)
Group 3
Midazolam (5mg/1ml ampoule) + Propofol (1% 20 mls ampoule)
干预措施: Midazolam and propofol (Drug)
结局指标
主要结局
Induction time
时间窗: Preoperatively - before the surgery
The time to reach a sedation level of ≥ 4 on Ramsay's sedation score.
Recovery time
时间窗: From end of drug infusion until recovery (defined as modified Aldrete score ≥9), assessed up to 24 hours postoperatively.
The time from the stoppage of the drug infusions till achieving a score of≥9 according to the modified Aldrete score.
Recovery time
时间窗: From end of drug infusion until recovery (defined as modified Aldrete score ≥9), assessed up to 24 hours postoperatively.
The time from the stoppage of the drug infusions till achieving a score of≥9 according to the modified Aldrete score.
Induction time
时间窗: Preoperatively - before the surgery
The time to reach a sedation level of ≥ 4 on Ramsay's sedation score.
次要结局
- Mean arterial pressure (MAP)(mmHg)(perioperatively)
- Ramsay Sedation Scale(Every 5 minutes from the start of the procedure until its completion, assessed up to 4 hours.)
- Endoscopist satisfaction(Perioperatively)
- Endoscopy procedure time(Peri- operatively)
- Rescue propofol total doses (mg)(Perioperatively)
- Sedation-related adverse effects (SRAEs) and complications(Perioperatively)
- Heart rate(Perioperatively)
- Peripheral oxygen saturation (SPO2)(Perioperatively)
- Mean arterial pressure (MAP)(mmHg)(perioperatively)
- Ramsay Sedation Scale(Every 5 minutes from the start of the procedure until its completion, assessed up to 4 hours.)
- Endoscopist satisfaction(Perioperatively)
- Endoscopy procedure time(Peri- operatively)
- Rescue propofol total doses (mg)(Perioperatively)
- Sedation-related adverse effects (SRAEs) and complications(Perioperatively)
- Heart rate(Perioperatively)
- Peripheral oxygen saturation (SPO2)(Perioperatively)