The Effect of Anesthesia Protocols Used in Gastrointestinal Endoscopy Procedures in Adolescents on the Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Intraoperative patient comfort assessed by Ramsey Sedation Scale
研究概览
简要总结
Gastrointestinal endoscopic procedures in adolescents require effective sedoanalgesia to ensure procedural comfort and prevent agitation. Pain control is an essential component of these procedures, and current practice commonly involves low-dose combinations of anesthetic agents. Sedoanalgesia protocols are selected according to patient characteristics and the anesthesiologist's clinical experience. This prospective observational study aims to compare the effects of ketodex and ketofol on intraoperative procedural comfort, postoperative recovery, and patient satisfaction in adolescents undergoing gastrointestinal endoscopy.
详细描述
Gastrointestinal endoscopic (GE) procedures require the use of sedoanalgesic agents to ensure patient comfort and procedural safety. In adolescent patients, deep sedation is often necessary to provide adequate procedural comfort and to prevent agitation. Additionally, GE procedures are inherently painful and require the use of analgesic medications as part of routine practice. The scientifically accepted approach involves the use of low-dose combinations of different anesthetic agents. The selection of the sedoanalgesia protocol during the procedure is shaped by patient characteristics as well as the experience and preference of the attending anesthesiologist.
The aim of this study is to evaluate the effects of routinely used sedoanalgesia protocols, specifically ketodex and ketofol, on intraoperative procedural comfort, postoperative recovery, and patient satisfaction in adolescent patients undergoing gastrointestinal endoscopy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-II, adolescents aged 10-18 years undergoing elective gastrointestinal endoscopic procedures
排除标准
- •Emergency cases
- •Children under 10 years of age
- •Children with mental retardation
- •Children whose parents refuse to participate in the study and children who do not consent to participate themselves
- •Children with known allergy, hypersensitivity, intolerance or contraindication to any of the sedoanalgesic drugs used
研究组 & 干预措施
Group D (Ketodex)
Patients receiving ketamine-dexmedetomidine sedation according to routine clinical practice.
干预措施: Ketodex (Drug)
Group P (Ketofol)
Patients receiving ketamine-propofol sedation according to routine clinical practice.
干预措施: Ketofol (Drug)
结局指标
主要结局
Intraoperative patient comfort assessed by Ramsey Sedation Scale
时间窗: During the intraoperative period
Intraoperative patient comfort was evaluated using the Ramsey Sedation Scale, a 6-point clinical scale assessing the level of sedation and patient responsiveness. The scale ranges from 1 to 6, where lower scores indicate agitation or anxiety and higher scores indicate deeper sedation and better patient comfort.
Intraoperative additional anesthetic drug requirement
时间窗: During the intraoperative period
The requirement for additional anesthetic medication administered during the intraoperative period was recorded. Additional anesthetic use was determined based on clinical signs of inadequate sedation or patient discomfort as judged by the attending anesthesiologist.
次要结局
- Postoperative recovery time assessed by recovery score(From the end of surgery until discharge from the postanesthesia care unit, assessed up to 24 hours postoperatively.)
- Emergence agitation assessed by emergence agitation score(From the end of anesthesia until discharge from the postanesthesia care unit, assessed up to 24 hours postoperatively.)
研究者
Dilek Yeniay
Anesthesiology and Reanimation physician
Giresun University