2023-505941-21-00招募中3 期
Effekten av intrathekalt morfin eller intravenöst lidokain på postoperativ återhämtning efter robotassisterad övre urologisk kirurgi. Randomiserad assessor-blindad multicenterstudie.
Region Oestergoetland3 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2023年10月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 3
- 主要终点
- QoR-15 score at postoperative day 1
研究概览
简要总结
To study whether the addition of spinal analgesia with bupivacaine and morphine in patients having robotic-assisted laparoscopic upper urinary tract surgery in general anesthesia improves recovery after surgery as quantified by the patient-centered outcome scale "Quality of Recovery 15"
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •The patient 1) is scheduled for elective robotic-assisted upper urinary tract surgery at one of the participating hospitals; 2) gives oral and written informed consent after having received oral and written information about the study
排除标准
- •The patient has a ASA-class of IV or above; the patient is a minor or declared incompetent, has severe psychiatric disease or is expected not to be able to understand the study information due to severe restrictions in vision, hearing, cognition, reading- or Swedish language abilities; the patient is pregnant or lactating or a fertile female (i.e. age < 45 and not sterilised) not using adequate contraception or not recently having had a negative pregnancy test; emergency surgery; research staff not available; significant simultaneous surgery on another organ; the anesthesiologist in charge has planned spinal or epidural analgesia; the patient has clear contraindications to spinal analgesia, e.g. severe coagulopathy, severe aortic stenosis, previous back surgery with rods, or spinal analgesia can be expected to be technically challenging (severe obesity, severe scoliosis); the patient has contraindications to lidocaine infusion: proven allergy to local anesthetics, myasthenia gravis, renal failure ( eGFR < 30), hepatic failure caused by acute hepatitis or cirrhosis (Child-Pugh B or higher), severe cardiac arrythmias or insufficiency (NYHA IIIb or higher); previous participation in the trial.
结局指标
主要结局
QoR-15 score at postoperative day 1
QoR-15 score at postoperative day 1
次要结局
- QoR-15 score preoperatively
- QoR-15 score at postoperative day 2
- pain (NRS) in rest and during motion 2hrs after arrival to the PACU/ICU/HDU
- pain (NRS) on POD 1-3
- pain (NRS) in rest and during motion at POD 7
- Time from arrival in the OR to start of surgery
- Time from end of surgery until leaving the OR
- Incidence of unplanned termination of the lidocaine infusion
- Amount of remifentanil in patients given remifentanil
- amount of intraoperative opiods in patients not receiving remifentantil
- length of stay at the PACU/ICU/HDU
- amount of opioids administered at the PACU/ICU/HDU during the first 24 hrs from the end of surgery
- PONV requiring treatment at 0-6hrs and 6-24 hrs postoperatively as well as during the whole postoperative stay
- "Time out-of-bed" on POD 1-3
- Amount of opioids administered during the first 24 hrs after end of surgery at the PACU/ICU/HDU and ward
- First POD passing gases
- First POD passing stool
- incidence of pruritus
- Length of stay and DAOH30
- Postoperative complications untill POD 30
- Requirement for opioids after discharge
- Incidence of respiratory depression leading to the use of a mu-antagonist within 48 hrs of induction of anesthesia
- Intraoperative fluid balance
- Time with low blood pressure during anesthesia
- Lowest MAP within 10 minutes after induction of anesthesia
- Highest MAP within 10 minutes of start of abdominal insufflation
- Fraction of patients needing norepinephrine before start of surgery 15 minutes after start of insufflation
- Intraoperative Cardiac Index
- Fraction of patients needing norepinephrine intraoperatively (later than 15 minutes after start of insufflation)
- Average infusion rate of norepinephrine, in patients receiving norepinephrine, before 15 minutes after start of insufflation
- Average infusion rate of norepinephrine, in patients receiving norepinephrine, after 15 minutes after start of insufflation
- Intraoperative Stroke Volume Index
- Intraoperative Cardiac Power Index and dPmx
- Intraoperative Pulse Pressure Variation and Stroke Volume Variation
- Intraoperative Systemic Vascular Resistance Index
- Intraoperative heart rate
- biochemical markers of inflammation
研究者
Hans Bahlmann
Scientific
Region Oestergoetland
研究点 (3)
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