Estimation of the ED50 of Propofol for Successful Colonoscope Insertion in Geriatric Patients: A Prospective Dose-finding Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- ED50
研究概览
简要总结
The aim of this prospective dose-finding study is to determine the ED50 of propofol required for successful colonoscope insertion in geriatric patients. The study is designed using Dixon's up-and-down sequential allocation method. Successful colonoscope insertion is defined as the absence of pain, movement, or vocal response, together with a MOAA/S score ≤2 at the second minute after induction, and maintained until the colonoscope pass the rectosigmoid junction. In cases of failure, an additional dose of propofol is administered, and the initial dose for the next patient was increased by 0.1 mg/kg. In cases of success, the initial dose for the next patient was decreased by 0.1 mg/kg.
The primary outcome is the determination of the ED50 of propofol for successful colonoscope insertion until passage of the rectosigmoid junction.
详细描述
The procedure is performed by an experienced endoscopist. If, during passage of the colonoscope through the rectosigmoid junction, the patient moves, experiences pain, vocalizes, or if the MOAA/S score is ≥3 at the second minute after induction, the insertion is defined as unsuccessful, and an additional rescue dose of 0.25-0.5 mg/kg propofol is titrated intravenously. The initial propofol dose for the next patient is then increased by 0.1 mg/kg.
If there is no movement during passage of the rectosigmoid junction, the patient reports no pain, and the MOAA/S score is ≤2 at the second minute after induction, the insertion is defined as successful, and the initial dose for the next patient is decreased by 0.1 mg/kg.
The conditions for colonoscope insertion are evaluated only at the initial attempt. If, after the start of the procedure, the patient experiences pain, moves, vocalizes, or the MOAA/S score is ≥3, an additional dose of 0.25-0.5 mg/kg propofol is titrated as required.
Throughout the procedure, the target is to maintain a MOAA/S score ≤2, which is systematically assessed at 2-minute intervals. Vital signs, procedure duration, and drug dosages are recorded for all patients.
At the end of the procedure, patients are awakened with verbal and tactile stimuli. After completion of colonoscopy, all patients are transferred to the post-anesthesia care unit for close monitoring until achieving a Modified Aldrete score of 10. Patients with a Modified Aldrete score of 10 are discharged.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients who provided informed consent to participate
- •Patients scheduled for colonoscopy
- •ASA physical status I-III
- •Male and female patients aged ≥65 years
排除标准
- •Patients who did not provide consent
- •Known allergy to propofol
- •Body weight <40 kg
- •Body mass index (BMI) >30 kg/m²
- •Presence of acute or chronic pain
- •Chronic alcohol consumption
- •Use of antipsychotic, antidepressant, or hypnotic medications
- •Patients with obstructive sleep apnea syndrome (STOP-Bang score ≥3)
- •Patients with known anorectal diseases such as hemorrhoids, anal fissure, or anal fistula
- •History of oncological disease
- •Uncontrolled hypertension (blood pressure >180/110 mmHg)
- •Severe hepatic or renal dysfunction
- •Acute respiratory tract infection or other chronic respiratory disorders
- •Patients with a history of colorectal surgery
研究组 & 干预措施
Group mono-Propofol
The study is designed using Dixon's up-and-down sequential allocation method. Successful colonoscope insertion is defined as the absence of pain, movement, or vocal response, together with a MOAA/S score ≤2 at the second minute after induction, and maintained until the colonoscope passes the rectosigmoid junction. In cases of failure, an additional dose of propofol is administered, and the initial dose for the next patient is increased by 0.1 mg/kg. In cases of success, the initial dose for the next patient is decreased by 0.1 mg/kg.
干预措施: Propofol (Drug)
结局指标
主要结局
ED50
时间窗: At 2 minutes after induction (during colonoscope insertion)
The median effective dose (ED50) of propofol required for successful colonoscope insertion in geriatric patients will be determined using the modified Dixon's up-and-down method. Successful insertion is defined as the absence of movement or vocalization and a MOAA/S score ≤2 within 2 minutes after induction, maintained until the colonoscope passes the rectosigmoid junction.
次要结局
- ED95(At 2 minutes after induction (during colonoscope insertion))
- Additional propofol dose(The cumulative amount of rescue propofol administered during the procedure will be recorded.)
- total propofol dose(The cumulative amount of total propofol administered during the procedure will be recorded.)
- Presence of pain during propofol injection(Immediately after first propofol administration)
- Heart rate(Baseline (before sedation), at colonoscope insertion, 2 minutes after insertion, and at the end of the procedure)
- mean arterial pressure(Baseline (before sedation), at colonoscope insertion, 2 minutes after insertion, and at the end of the procedure)
- SpO₂(Baseline (before sedation), at colonoscope insertion, 2 minutes after insertion, and at the end of the procedure)
- Procedure interruptions due to airway interventions(Throughout the colonoscopy procedure)
- Minimum SpO₂ value during the procedure(Throughout the colonoscopy procedure)
研究者
Bedirhan Günel
Principal Investigator
Kocaeli City Hospital