Prospective Study to Evaluate the Central Venous Oxygen Saturation and the Regional Cerebral Oxygen Saturation Monitoring at Different Stages of Neuromuscular Blockade in High-risk Patients Scheduled for Colorectal Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- the central venous oxygen saturation (ScvO2)
研究概览
简要总结
Anesthesia favouring deep/intense neuromuscular blockade during laparoscopy may restore hemodynamics. However, no studies has been performed comparing oxygenation parameters during laparoscopy in colorectal surgery in either moderate or intense neuromuscular blockade.
The investigators aim to investigate whether the intense neuromuscular blockade produces a better oxygenation profile measured by the central venous oxygen saturation than the moderate neuromuscular blockade.
This is a one centre, prospective clinical trial to compare oxygenation data at different stages of neuromuscular blockade in high-risk patients scheduled for colorectal surgery. Data recording will be blinded to the anesthesiologist in charge of the patient, who will manage patients by a determined protocol, based on stroke volume data to direct fluidotherapy. Data analyzer will be not be involved in the study design or in writing reports from the study. Inclusion criteria: Be a candidate to a colorectal surgical resection procedure and one of these conditions: ≥ 70 y.o, or respiratory co-morbidity, or cardiac co-morbidity or haemoglobin level < 11g/dl. The primary outcome is the absolute number of the central venous oxygen saturation, measured at the following points: basal, after tracheal intubation, before pneumoperitoneum or abdominal incision, after pneumoperitoneum or abdominal incision, 5 and 10 minutes before administration of rocuronio to produce intense blockade, continuously during profound neuromuscular blockade until the end of surgery, before sugammadex administration, after sugammadex administration, after tracheal extubation, for the 24 hours post surgical. Data of the regional cerebral oxygen saturation will be measured at the same points.
The investigators hypothesize that oxygenation data will be favourable by applying the intense neuromuscular blockade in comparison with moderate neuromuscular blockade. Also, the investigators hypothesize that oxygenation data obtained during the whole procedure including the first 24-hours post-surgery, measured by the regional cerebral oxygen saturation are comparable to data obtained by the central venous oxygen saturation. The investigators want to obtain information about influence in the outcome of producing profound neuromuscular blockade during laparoscopy colorectal by comparison of outcome data with matched historical control.
详细描述
The primary objective are to determine changes in the central venous oxygen saturation (ScvO2) and in the regional cerebral oxygen saturation (rSO2), measured at the following points: basal, after tracheal intubation, before pneumoperitoneum or abdominal incision, after pneumoperitoneum or abdominal incision, 5 and 10 minutes with moderate neuromuscular blockade and before administration of rocuronium to produce intense neuromuscular blockade, 5 and 10 minutes after the intense neuromuscular blockade is produced, at the end of surgery before sugammadex administration, after sugammadex administration, and after tracheal extubation.
Primary end-points:
The absolute number of ScvO2 values at the previously described points and at any fluid and drug administration related to Goal-therapy protocol
Secondary end-points:
The absolute number of rSO2 values at the previously described points and at any fluid and drug administration related to Goal-therapy protocol Any decrease of ScvO2 or rSO2 > 10% of the referee value The stroke volume value measured at same points. Plasmatic values of hemoglobin, creatinine, arterial oxygen pressure, arterial carbon dioxide pressure, Bicarbonate, pH, potassium, Sodium, glucose, lactate. Abdominal and pneumoperitoneum pressures at the previously determined points. Outcome variables and daily cost of patient
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients scheduled for elective colorectal surgery
- •With one of these following conditions: ≥ 70 year old; Respiratory co-morbidity defined as: obstructive pulmonary disease diagnosed by abnormal spirometry test, alveolar-arterial oxygen differences >15 mmHg, Sleep apnea syndrom by Eporhw criteria; Cardiac co-morbidity determined by New York functional Class II-IV; Plasmatic Hemoglobin level < 11g/dl
排除标准
- •< 70 y.o. without respiratory or cardiac disease
- •Known history of thromboembolic events in 30 days
- •Known or suspected pregnancy
- •Known or suspected allergy to any drug or related products used to provide anesthesia.
- •Known presence of congenital disorder.
- •Patients treated with aspirin, warfarin and other anti haemostatic drugs
- •Contraindications to dobutamine
- •Patient reluctant to participate in the trial
结局指标
主要结局
the central venous oxygen saturation (ScvO2)
时间窗: intraoperative and 24 hours postoperative period
The primary objective is to study the central venous oxygen saturation (ScvO2) measured at the following points: basal, after tracheal intubation, before pneumoperitoneun or abdominal incision, after pneumoperitoneun or abdominal incision, 5 and 10 minutes before administration of rocuronium to produce intense neuromuscular blockade, continuously during profound neuromuscular blockade until the end of surgery, before sugammadex administration, after sugammadex administration, after tracheal extubation, first 24 hour postsurgery.
次要结局
- the central venous oxygen saturation (ScvO2)the regional cerebral oxygen saturation (rSO2)(intraoperative and 24 hours postoperative period)
- the regional cerebral oxygen saturation (rSO2)(intraoperative and 24 hours postoperative period)
- Fluidotherapy and Blood components transfusion(intraoperative and 24 hours postoperative period)
- pneumoperitoneum and abdominal pressures(intraoperative and 24 hours postoperative period)
- Stroke volume(intraoperative and 24 hours postoperative period)
- postoperative outcome(90 days-postsurgery)
研究者
Antoni Sabate
Professor
Hospital Universitari de Bellvitge