Effect of Intravenous S-ketamine on Opioid Consumption and Postoperative Pain in Patients Undergoing Breast Cancer Surgery：a Multicenter, Randomised, Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 345
- 试验地点
- 1
- 主要终点
- consumption of sufentanil
研究概览
简要总结
Female patients with an American Society of Anesthesia (ASA) physical status I-II, scheduled for elective breast cancer surgery will be included in the study. Subjects will be randomly assigned to one of three groups: the placebo group, the low-dose S-ketamine group, and the high-dose S-ketamine group. The primary outcome is the consumption of sufentanil during the surgery.
详细描述
All patients will be scheduled to a propofol-remifentanil general anesthesia and receive non-steroid anti-inflammatory drug before incision. Bolus sufentanil will be administered according to the blood pressure, heart rate and bispectral index perioperatively. Patients unable to understand the study procedure or unable to give informed consent, with concurrent analgesic or sedative medication, with history of chronic pain, psychiatric disorders, or alcohol or drug abuse, with an allergy to the study medication, who are pregnant or breast feeding, with a BMI >30 and <18 kg/m2, with severe cardiac, pulmonary, hepatic or renal dysfunction, with intracranial hypertension will be excluded.
Subjects will be randomly assigned to one of three groups: the placebo group, the low-dose S-ketamine group, and the high-dose S-ketamine group. The study medication will be administered in a bolus injected over 30 s after induction, followed by continuous infusion, which started after the initial bolus. The placebo group will receive a bolus of 0.9% saline, followed by continuous infusion of 0.9% saline. The low-dose ketamine group will be administered a bolus of 0.5 mg/kg S-ketamine in saline, followed by 2μg/kg/min S-ketamine in saline, whereas the high-dose ketamine group will be administered a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 4μg/kg/min S-ketamine in saline. The syringes and infusions will be identical for all of the groups and will run at the same rate in all subjects to enable blinding of the investigators. Study medication will be terminated 30 min prior to the end of the surgery. After surgery and in the postanesthesia care unit, patients will be asked about their pain level on a numeric rating scale (NRS), and about the presence of intraoperative awareness, nausea, vomiting, and hallucinations. Rescue analgesia of sufentanil will be provided when NRS ≥ 4 or patients require. Pain level will also be assessed at 0.5, 2, 4, 6, 12 and 24 hour postoperatively as well as 3 and 6 month after the surgery. Depression scale will be evaluated before the surgery and in the 7th postoperative day.
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)
盲法说明
The syringes and infusions will be identical for all of the groups and will run at the same rate in all subjects to enable blinding of the investigators. Outcomes will be evaluated by anesthesiologists who are blinded to the treatment allocation. Patients, nurses, observers, and the statistician will be blinded to patient allocation throughout the study period.
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with an American Society of Anesthesia (ASA) physical status I-II
- •Scheduled for elective breast cancer surgery
排除标准
- •Patients unable to understand the study procedure or unable to give informed consent
- •with concurrent analgesic or sedative medication,
- •with history of chronic pain
- •with history of psychiatric disorders
- •with history of alcohol or drug abuse
- •with an allergy to the study medication
- •who are pregnant or breast feeding
- •with a BMI >30 and <18 kg/m^2
- •with severe cardiac, pulmonary, hepatic or renal dysfunction
- •with intracranial hypertension
研究组 & 干预措施
Placebo group
Patients in the placebo group will receive a bolus of 0.9% saline, followed by continuous infusion of 0.9% saline until 30 min prior to the end of the surgery.
干预措施: Placebo (Drug)
High-dose ketamine group
Patients in the low-dose ketamine group will receive a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 4 μg/kg/min S-ketamine in saline until 30 min prior to the end of the surgery.
干预措施: S-ketamine (high dose) (Drug)
Low-dose ketamine group
Patients in the low-dose ketamine group will receive a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 2 μg/kg/min S-ketamine in saline until 30 min prior to the end of the surgery.
干预措施: S-ketamine (low dose) (Drug)
结局指标
主要结局
consumption of sufentanil
时间窗: during the surgery
the consumption of sufentanil during the surgery.
次要结局
- sleep quality scale(sleep quality scale will be assessed in the morning (8:00 am）of first postoperative day)
- adverse effects(through 24 hours after the surgery)
- ambulation time(7 days after surgery)
- consumption of vasoactive agents(during the surgery)
- blood pressure(before anesthesia, prior to incision, 5, 10, 30, 60 and 120 minutes after incision, at the end of surgery and 30 minutes after surgery)
- heart rate(before anesthesia, prior to incision, 5, 10, 30, 60 and 120 minutes after incision, at the end of surgery and 30 minutes after surgery)
- bispectral index(before anesthesia, prior to incision, 5, 10, 30, 60 and 120 minutes after incision, at the end of surgery and 30 minutes after surgery)
- Edinburgh postnatal depression scale(before surgery, at the 7th day and 3 months after surgery)
- hospitalization postoperatively(two weeks after surgery)
- recovery time(at the time when patients waking up)
- postoperative pain assessment(at 0.5, 2, 4, 6, 12 and 24 hours respectively after surgery; Month 3 and Month 6 after surgery)
- consumption of analgesics(in the first 24 hour after surgery)
- Richmond Agitation-Sedation Scale (RASS)(30 minutes after surgery)
- consumption of remifentanil(during the surgery)
- length of anesthesia(at the end of anesthesia)
- consumption of propofol(during the surgery)
- length of surgery(at the end of surgery)
研究者
Yun Wu
Principal Investigator
The Second Hospital of Anhui Medical University