Low Pressure Pneumoperitoneum and Deep Neuromuscular Blockade Versus Standard Laparoscopy During RARP to Improve the Quality of Recovery and Immune Homeostasis; Study Protocol for a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Quality of Recovery - 40 Items Questionnaire Score (QoR-40)
研究概览
简要总结
Intra-abdominal pressure (IAP) needed to create sufficient workspace during laparoscopic surgery affects the surrounding organs with ischemia-reperfusion injury and a systemic immune response. This effect is related to postoperative recovery, pain scores, opioid consumption, bowel function recovery, morbidity and possibly mortality. In clinical practice standard pressures of 12-16mmHg are applied instead of the lowest possible IAP, but accumulating evidence shows lower pressure pneumoperitoneum (PNP) (6-8mmHg) to be non-compromising for sufficient workspace, when combined with deep neuromuscular blockade (NMB) in a vast majority of patients. Therefore, low impact laparoscopy, meaning low pressure PNP facilitated by deep NMB, could be a valuable addition to Enhanced Recovery After Surgery (ERAS) Protocols.
The use of low pressure PNP may also reduce hypoxic injury and the release of DAMPs and thereby contributing to a better preservation of innate immune function which may help to reduce the risk of infectious complications.
The participants will be randomly assigned to one of the experimental groups with low impact laparoscopy or one of the control groups with standard laparoscopy.
详细描述
Intra-abdominal pressure (IAP) needed to create sufficient workspace during laparoscopic surgery affects the surrounding organs with ischemia-reperfusion injury and a systemic immune response. This effect is related to postoperative recovery, pain scores, opioid consumption, bowel function recovery, morbidity and possibly mortality. Therefore, low impact laparoscopy, meaning low pressure PNP facilitated by deep NMB, could be a valuable addition to Enhanced Recovery After Surgery (ERAS) Protocols.
The use of low pressure PNP may also reduce hypoxic injury and the release of DAMPs and thereby contributing to a better preservation of innate immune function which may help to reduce the risk of infectious complications.
The participants will be randomly assigned to the experimental group 1: low impact laparoscopy (low pressure (8 mmHg) and deep NMB (PTC 1-2)); 8 mmHg IAP after trocar introduction for perfusion measurement or the experimental group 2: low impact laparoscopy (low pressure (8 mmHg) and deep NMB (PTC 1-2)); 12 mmHg IAP after trocar introduction for perfusion measurement, or control group 1: standard laparoscopy (standard pressure (12 mmHg) and moderate NMB (TOF 1-2)); 8 mmHg IAP after trocar introduction for perfusion measurement, or control group 2: standard laparoscopy (standard pressure (12 mmHg) and moderate NMB (TOF 1-2)); 12 mmHg IAP after trocar introduction for perfusion measurement.
ICG injection will take place with starting pressure to quantify parietal peritoneum perfusion, and a parietal peritoneal biopsy will be taken. At the end of surgery, a second parietal peritoneum biopsy will be taken.
NB: After introduction of the camera trocar, insufflation of carbon dioxide is titrated to an IAP of 8mmHg in group A and C, and 14 mmHg in group B and D. After placement of the last trocar the injection of ICG and video registration of peritoneum will take place, and a peritoneal biopsy will be taken. There after surgery will take place with an IAP of 14mmHg in the control groups (C and D), and an IAP of 8mmHg in the experimental groups (A and B). In the control groups (C and D)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Age ≥ 18 years
- •Undergoing elective robot assisted radical prostatectomy (RARP)
- •Obtained informed consent
排除标准
- •Laparoscopic radical prostatectomy without robot assistance
- •Insufficient control of the Dutch language to read the patient information and to fill out de questionnaires
- •Neo-adjuvant chemotherapy
- •Chronic use of analgesics or psychotropic drugs
- •Use of NSAID's shorter than 5 days before surgery
- •Severe liver- or renal disease
- •Neuromuscular disease
- •Hyperthyroidism or thyroid adenomas
- •Deficiency of vitamin K dependent clotting factors or coagulopathy
- •Planned diagnostics or treatment with radioactive iodine < 1 week after surgery
- •Indication for rapid sequence induction
- •BMI >35kg/m2
- •Known of suspected hypersensitivity to ICG, sodium iodide, iodine, rocuronium or sugammadex
- •Use of medication interfering with ICG absorption as listed in the summary of product characteristics (SPC); anticonvulsants, bisulphite compounds, haloperidol, heroin, meperidine, metamizol, methadone, morphium, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, cyclopropane, probencid
结局指标
主要结局
Quality of Recovery - 40 Items Questionnaire Score (QoR-40)
时间窗: Pre-operative
40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)
次要结局
- Health Status With Short Form Survey (SF-36)(Measure pre-operative, on day 12 and at 3 months after surgery)
- Operating Conditions(During operation for up to 8 hours)
- Pain Score With NRS(Preset timepoints during hospital stay (1hr, 6hrs, 12hrs, day1), up to 3 days maximum. No measurements after discharge to home.)
- Postoperative Nausea and Vomiting (PONV)(During hospital stay up to 3 days)
- Analgesia Use(During hospital stay up to 3 days)
- Hospital Stay(from admission up to 3 days)
- Complications(Day of surgery untill 30days after surgery)
- Immune Response Represented by IL-10(Pre-operative, postoperative day 1 and 12)
- Immune Response Represented by IL-6(Pre-operative, postoperative day 1 and 12)
- Chronic Pain With McGill Pain Questionnaire (MPQ)(3 months after surgery)
- Perfusion Index of the Parietal Peritoneum(From ICG injection, up to 20 seconds)