Efficacy and Safety of Fospropofol Disodium Sedation for Same-day Bidirectional Endoscopy in Elderly Patients: a Prospective, Single-center, Randomized, Double-blind, Non-inferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 256
- 主要终点
- The success rate of same-day bidirectional endoscopy
研究概览
简要总结
Introduction: Fospropofol disodium is a novel prodrug that has improved pharmacokinetic and pharmacodynamic properties compared with propofol. This trial aims to compare the efficacy and safety of fospropofol versus propofol sedation for same-day bidirectional endoscopy in elderly patients.
Methods and analysis: This is a prospective, single-center, double-blind, randomized, propofol-controlled, non-inferiority trial. A total of 256 adult patients scheduled for same-day bidirectional endoscopy under sedation will be randomly allocated, in a 1:1 ratio, to a fospropofol group or a propofol group (n=128 in each group). All patients will receive analgesic pretreatment with sufentanil 5 μg. Two minutes later, an initial bolus dose of fospropofol 6.5 mg/kg or 1.5 mg/kg propofol and supplemental doses of fospropofol 1.6 mg/kg or 0.5 mg/kg propofol will be titrated as needed to the target sedation levels during the procedures. The primary outcome is the success rate of same-day bidirectional endoscopy. Secondary outcomes include the time to successful induction of sedation, duration, time to being fully alert, time to patient discharge, endoscopist satisfaction, patient satisfaction, and the top-up frequency and dosage of sedative medications. The safety endpoints consist of adverse events (AEs) concerning cough reflex, gag reflexes, body movement, muscular tremor, pain on injection. Sedation-related AEs, including episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia, will be also recorded. Data will be analyzed on the intention-to-treat basis.
Discussion: The investigators hypothesize that the efficacy and safety of fospropofol sedation for elderly patients undergoing same-visit bidirectional endoscopy will not be inferior to that of propofol. The findings will provide daily practice of sedation regimens for same-day bidirectional endoscopy in elderly patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •65 years or older
- •American Society of Anesthesiologists (ASA) physical status I to III
- •Body mass index (BMI) 18-30 kg/m2
- •Scheduled for same-day bidirectional endoscopy under sedation
排除标准
- •Severe cardiovascular, pulmonary, renal, or liver diseases
- •Previous hypotension (systolic blood pressure ≤90 mmHg), bradycardia (heart rate <50 beats/min), or hypoxemia (SpO2 <90%)
- •Neurocognitive or psychiatric disorders
- •Contraindications to gastroscopy (gastric retention, long-term aspirin administration, etc.)
- •Hypersensitivity to study medications
- •Drug or alcohol misuse
- •Definite upper respiratory tract infection
- •Refusal for participation
研究组 & 干预措施
fospropofol
干预措施: fospropofol sedation (Drug)
propofol
干预措施: Propofol (Drug)
结局指标
主要结局
The success rate of same-day bidirectional endoscopy
时间窗: Immediate time after sedation emergence
The success rate of the gastrointestinal endoscopy was assessed according to the following criteria : 1) completion of the gastrointestinal endoscopy; 2) no need for rescue sedative/anesthetic, which means the top-up doses of the experimental drugs were administered no more than five times within any 15-min window from the initial administration to the end of the procedure.
次要结局
- Incidence of adverse events (AEs) at timepoint 2(Intraoperative (during sedation))
- Incidence of adverse events (AEs) at timepoint 3(Intraoperative (the timepoint of sedation emergence))
- Incidence of adverse events (AEs) at timepoint 6(Immediate time of hospital discharge)
- The time to successful induction of sedation(Immediate time after sedation emergence)
- Time to being fully alert(Immediate time after sedation emergence)
- Time to patient discharge(Immediate time of hospital discharge)
- Endoscopist's satisfaction questionnaire(Immediate time after sedation procedure completion)
- Patient's satisfaction questionnaire(Immediate time of hospital discharge)
- The top-up frequency and dosage of sedative medications(Immediate time after sedation emergence)
- Incidence of adverse events (AEs) at timepoint 1(baseline (Prior to sedation))
- Incidence of adverse events (AEs) at timepoint 4(15 min in post-anesthesia care unit)
- Incidence of adverse events (AEs) at timepoint 5(30 min in post-anesthesia care unit)
研究者
Xiaofeng WANG
Principal investigator
Shanghai 6th People's Hospital