The Impact of Low-Dose Esketamine Combined With Ciprofol on the Quality of Early Postoperative Recovery Among Elderly Patients Undergoing Painless Gastroscopy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 376
- 试验地点
- 1
- 主要终点
- postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score
研究概览
简要总结
To explore the impact of esketamine combined with ciprofol on the quality of early postoperative recovery in elderly patients undergoing painless gastroscopy, as well as the effectiveness and safety of this regimen.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Scheduled painless gastroscopy examination and treatment
- •Age 60-75 years old
- •ASA grade Ⅰ-Ⅱ
- •The respiratory tract is unobstructed and there is no difficult airway
- •No history of allergy to etomidate and cyclopropofol
- •Participants with normal heart, liver, lung, and kidney functions
- •Able to complete the QoR-15, MMSE, and HADS scale assessments
- •lnformed consent, voluntary participation in the trial, and signed by the patient informed consent
排除标准
- •Participants with concurrent dysfunction of major organs.
- •Participants with a history of mental illness and abuse of sedative drugs
- •Participants with allergies or contraindications to the study drugs
- •Participants with severe visual, auditory, or speech communication impairments
- •Participants with acute gastrointestinal inflammation or obstruction
- •History of uncontrolled diabetes, hypertension, and hypotension
- •Participants with malignant tumors, severe hyperkalemia, bronchial asthma, or excessive obesity (BMI > 30kg/m2)
- •Participants with aneurysmal vascular diseases of the thoracic and abdominal aorta, intracranial and peripheral arterial vessels.
- •Unable to cooperate with the QoR-15, MMSE, and HADS scale assessments
研究组 & 干预措施
Ciprofol group (C group)
Ciprofol group will be started with ciprofol 0.2-0.4 mg/kg.
干预措施: Ciprofol (Drug)
The group of remifentanil 0.5ug/kg combined with ciprofol(R group)
R group will be started with remifentanil 0.5ug/kg and ciprofol 0.2-0.4 mg/kg.
干预措施: Remifentanil and ciprofol (Drug)
The group of esketamine 0.3mg/kg combined with ciprofol(E1 group)
E1 group will be started with esketamine 0.3mg/kg and ciprofol 0.2-0.4 mg/kg.
干预措施: esketamine 0.3mg/kg and ciprofol (Drug)
The group of esketamine 0.5mg/kg combined with ciprofol(E2 group)
E2 group will be started with esketamine 0.5mg/kg and ciprofol 0.2-0.4 mg/kg.
干预措施: esketamine 0.5mg/kg and ciprofol (Drug)
结局指标
主要结局
postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score
时间窗: Baseline (30 min before surgery), postoperative day 1
Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1(minimum value : 0, maximum value : 150, the higher the score, the better the result)
次要结局
- postoperative day 3(POD3) Quality of Recovery(QoR)-15 questionnaire score(Postoperative day 3 and 7)
- Cognitive function assessment(Baseline (30 min before surgery), postoperative day 1,3 and 7)
- Hospital anxiety and depression scale ( HADS ) score.(Baseline (30 min before surgery), postoperative day 1,3 and 7)
- Dosage of ciprofol(During endoscopic examination)
- Heart rate (HR)(Baseline，during surgery and arrived at PACU (up to 30 minutes after surgery))
- Pulse oxygen saturation (SpO2)(Baseline, during surgery and arrived at PACU (up to 30 minutes after surgery))
- Mean blood pressure (MBP)(Baseline, during surgery and arrived at PACU (up to 30 minutes after surgery))
- Patient satisfaction levels(30 minutes at recovery room.)
研究者
Ju Gao
Study Director
Northern Jiangsu People's Hospital