Comparison of the Analgesic Effect of Oliceridine Versus Morphine or Sufentanil for Postoperative Analgesia in Lumbar Surgeries: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The VAS pain scores at rest and during exercise of the three groups of patients after the operation
研究概览
简要总结
Objective: This study aimed to compare the efficacy and safety of oliceridine versus morphine and sufentanil for postoperative analgesia following elective lumbar spine surgery.
Methods: In this randomized, controlled trial, 90 patients scheduled for lumbar spine surgery were allocated in a 1:1:1 ratio to receive postoperative intravenous patient-controlled analgesia (PCIA) with either oliceridine (Group O，1.5mg oliceridine for loading dose， 0.5mg/kg oliceridine for PICA), morphine (Group M，4mg morphine for loading dose，1.5mg/kg morphine for PICA), or sufentanil (Group S，4ug sufentanil for loading dose，1.5ug/kg sufentanil for PICA). The primary outcome was the movement Visual Analogue Scale (VAS) score at 6 hours postoperatively. Secondary outcomes included resting and movement VAS scores, ramsay sation score at 0.5, 2, 6, 12, 24, and 48 hours postoperatively (excluding the motor VAS score at 6 hours postoperatively); number of PCIA demands and rescue analgesic requirements within 48 hours; hemodynamic parameters at 5, 10, 15, 30, and 60 minutes after administration of the initial loading dose. The incidence of adverse events within 48 hours postoperatively, such as nausea and vomiting, somnolence, respiratory depression, or pruritus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lumbar spine surgery with ASA grades I-III
- •Aged 18-65 years
- •Ethically, the patient voluntarily accepted this trial and signed the informed consent form
排除标准
- •Severe respiratory and circulatory system diseases
- •Nervous system disease
- •Mental and psychological disorders
- •Abnormal liver and kidney functions
- •Participated in another drug clinical research within the past 30 days
研究组 & 干预措施
The sufentanil group(S)
A loading dose of 4ug of sufentanil was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03ug.kg-1.h-1 was connected. Sufentanil was mixed with normal saline to 100ml at a rate of 2ml per hour
干预措施: Sufentanil (Drug)
The morphine group(M)
A loading dose of 4mg of morphine was intravenously injected. Ten minutes later, an intravenous analgesic pump was connected to 0.03mg.kg-1.h-1 morphine mixed with normal saline to 100ml at a rate of 2ml per hour
干预措施: Morphine (Drug)
结局指标
主要结局
The VAS pain scores at rest and during exercise of the three groups of patients after the operation
时间窗: at 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours and 48 hours after the operation
次要结局
未报告次要终点