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临床试验/NCT06865027
NCT06865027已完成不适用

Effect of Arterial Carbon Dioxide Levels on Cerebral Blood Flow and Cerebral Autoregulation in Steep Trendelenburg Position During Robot-assisted Prostatectomy, and Its Effect on Postoperative Cognition - A Clinical Blinded Randomized Trial

University Hospital, Akershus2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年1月24日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
2
主要终点
ICA flow

研究概览

简要总结

Patients scheduled for robot-assisted prostatectomy will be randomized to either high or low concentrations of carbon dioxide in the blood. This will be managed by applying different ventilation strategies during anesthesia.The levels will be distinctly different.

The investigators will assess whether different concentrations of carbon dioxide in blood results in different brain blood flow levels and different intracranial pressure during laparascopic surgery in the head-down tilted position. The investigators also will assess if different carbon dioxide level will manifest in different cognitive abilities in the two study groups, measured on day 1 post-surgery.

详细描述

Detailed Description: The carotid artery carries blood into the brain. Therefore, blood flow levels in the carotid artery may be used to assess brain perfusion. Brain perfusion is carefully regulated by the body, to ensure that the brain always receives enough oxygen and nutrients. During prostate surgery using laparoscopic techniques, the patient lies tilted on the operating table, with their head markedly lower than their legs. The investigators aim to study the effect on cerebral blood flow of a head-down tilted body position in combination with anesthesia and laparoscopic surgery, and particularly how cerebral blood flow is influenced by the participants' breathing pattern. The study aims to achieve insights that may be used to improve the treatment of vulnerable surgical patients, such as those with cerebrovascular disease or severe heart disease.

Anesthesia and surgery will proceed as usual, with the exception that the respiratory support the participants receive during the surgery will be adjusted as described below. The participants will receive standard monitoring of heart rate, blood pressure, and blood oxygen levels. Before surgery, the anesthesia team will per routine insert two plastic cannulas into the left arm for administering medication, and a plastic cannula into the participant's left wrist for close monitoring of the participant's blood pressure.

Study participants will undergo four additional steps:

  1. Before surgery, an anesthesiologist will insert a thin plastic cannula into a superficial vein on the side of the neck. The cannula is the same type as the ones used on the arm and has a diameter of 1.1 mm. The purpose of this cannula is to measure the pressure of the blood returning from the brain to the heart. The procedure involves brief, moderate pain associated with the needle insertion. The plastic cannula will be removed before the participant wakes up from anesthesia.
  2. Just before and during surgery, a trained anesthesiologist will perform ultrasound measurements on the right side of the participant's neck, temple, and the outside of the eyelid. Each measurement lasts 4-5 minutes. This will not prolong the time spent in the operating room. The measurements will cause no discomfort.
  3. All patients undergoing prostate removal with robotic surgery receive respiratory support with a ventilator during anesthesia. In this study, the investigators will adjust the ventilator to control the carbon dioxide (CO2) levels towards either the lower or upper normal range for CO2. A blinded randomization will determine the group assignment. Regardless of which group a participant is assigned to, their CO2 level will be maintained within a range routinely used during anesthesia and considered completely safe.

In the project, the investigators will collect and record participant information. The investigators will store recordings of the participants' pulse, blood pressure, breathing depth and rhythm, levels of oxygen and CO2 in the participants' blood, medication doses used during surgery, and results of blood tests taken during surgery. From the participants' medical records, the investigators will retrieve and record the participants' age, gender, height, weight, whether the participants have chronic diseases, and which regular medications the participants use.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

The participant and investigator are blinded. The anesthesia providers are not blinded.

入排标准

年龄范围
55 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Males 55-80 years old, accepted by surgeon and attending anesthesiologist for RALP surgery.

排除标准

  • Poorly controlled hypertension (resting BP >165/90 on pre-study consult).
  • Emphysema of the lung.
  • Previous spontaneous pneumothorax.
  • Cerebrovascular disease. Including but not limited to previous SAH, EDH, SDH, hemorrhage from AVM, known AVM and stenosis in carotid or cerebral arteries.
  • Intracranial malignancy or metastases from primary cancer.
  • Significant cardiovascular disease (NYHA class III or IV).
  • Renal failure grade 4 or 5 (estimated GFR <30).
  • Anatomical hinders for performing ultrasound of the right carotid artery or middle cerebral artery.
  • Primary language other than Scandinavian.
  • Diagnosed dementia of any subtype.

研究组 & 干预措施

Hypercapnia

Other

PaCO2: 6.4-7.0 kPa

干预措施: Ventilation strategy (Other)

Normocapnia

Other

PaCO2: 5.0-5.5 kPa

干预措施: Ventilation strategy (Other)

结局指标

主要结局

ICA flow

时间窗: day of surgery

Changes in cerebral blood flow (ml/s) during surgery

ICA flow

时间窗: day of surgery

Changes in cerebral blood flow (ml/s) during surgery

次要结局

  • Cerebral perfusion pressure(Day of surgery)
  • Cardiac index (L/min)(Day of surgery)
  • Cognitive performance(5 days pre-surgery and 1 day post-surgery)
  • Cerebral perfusion pressure(Day of surgery)
  • Cardiac index (L/min)(Day of surgery)

研究者

发起方
University Hospital, Akershus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Signe Søvik

Professor, Senior Consultant, PhD

University Hospital, Akershus

研究点 (2)

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