Efficacy and Safety of Propofol in Combination With Different Esketamine Doses for Anesthesia During Loop Electrosurgical Excision Procedure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Respiratory Rate
研究概览
简要总结
The goal of this prospective, randomized controlled study study is to investigate the efficacy and safety of propofol combined with different doses of esketamine (ESK) for anesthesia during loop electrosurgical excision procedure (LEEP).Ninety female patients undergoing LEEP were randomly allocated to three groups.It aims to answer :1.The effect of esketamine combined with propofol in respiration, circulation, etc,during LEEP. 2.The appropriate dosage of esketamine when combined with propofol in LEEP anesthesia.
详细描述
To investigate the efficacy and safety of propofol combined with different doses of esketamine (ESK) for anesthesia during loop electrosurgical excision procedure (LEEP). Ninety female patients undergoing LEEP were randomly allocated to three groups: group P (2 mg/kg propofol + saline), group propofol + esketamine(PK)1 (1.5 mg/kg propofol + 0.5 mg/kg ESK), and group PK2 (1.5 mg/kg propofol + 0.25 mg/kg ESK). Parameters including mean arterial pressure (MAP), heart rate (HR), respiratory rate (RR), oxygen saturation (SPO2), and venous carbon dioxide (PvCO2) were recorded. Additionally, the need for supplemental propofol, jaw thrust maneuver or ventilation, postoperative awakening time, and adverse reactions were assessed.
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
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Patients who refused to participate
- •History of hypertension, hyperthyroidism, or neurological or mental disorder
- •Currently taking or has taken opioids and non-steroidal anti-inflammatory drugs within 48 h before surgery
- •Participated in other drug clinical trials within 4 weeks
- •Allergy to esketamine or propofol
- •History of opioid or esketamine addiction
研究组 & 干预措施
group PK1
Intravenous injection of 0.5 mg/kg esketamine followed by 1.5 mg/kg of propofol
干预措施: intravenous injection of propofol +esketamine (Drug)
group P
Intravenous injection of an equivalent dose of normal saline followed by 2 mg/kg of propofol
干预措施: intravenous injection of propofol only (Drug)
group PK2
Intravenous injection of 0.25 mg/kg esketamine followed by 1.5 mg/kg of propofol
干预措施: intravenous injection of propofol +esketamine (Drug)
结局指标
主要结局
Respiratory Rate
时间窗: Immediately upon entering the operating room , 1 and 5 minutes after injection of anesthetics
The respiratory rate (RR) was monitored from 3-lead ECG
Heart Rate
时间窗: Immediately upon entering the operating room , 1 and 5 minutes after injection of anesthetics
The heart rate (HR) was monitored using 3-lead ECG
Mean Arterial Pressure
时间窗: Immediately upon entering the operating room, 1 and 5 minutes after injection of anesthetics
The mean arterial pressure (MAP) was monitored using Noninvasive blood pressure monitor
Venous Carbon Dioxide
时间窗: Immediately upon entering the operating room and 5 minutes after injection of anesthetics
The venous carbon dioxide (PvCO2) was monitored using blood-gas analyzer
次要结局
- number of jaw thrust maneuver or face mask ventilation(On the day of surgery, from the instant the anesthesia induction is completed to the instant completion of surgery,up to 10 minutes)
- incidences of postoperative vertigo, nausea, agitation and delirium(On the day of surgery,from the moment the patient wakes up (when MOAA score >4) to the moment the patient leaving the recovery room,up to 30minutes)
- number of additional propofol usage(On the day of surgery, from the instant the anesthesia induction is completed to the instant completion of surgery,up to 10 minutes)
- postoperative awakening time(On the day of surgery, from the instant completion of surgery to the moment the patient wakes up (when MOAA score >4),up to 10 minutes)
研究者
Qian Wu
Principal Investigator
First Affiliated Hospital of Chongqing Medical University