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| ID | Type | Description | Link |
|---|---|---|---|
| 2022088 | Other Grant/Funding Number | South-Eastern Norway Regional Health Authority |
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| Name | Class |
|---|---|
| University of Oslo | OTHER |
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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.
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:
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.
Cognitive tests of reaction time and problem-solving abilities will be administered a few days before and one day after surgery.
Receiving information about an illness, undergoing a surgical procedure, receiving general anesthesia, peroperative CO2 levels, body position during robotic surgery, and postoperative pain medication all affect the body physically and may trigger stress and anxiety. The investigators want to assess this impact using a well-established method that tests reaction time through five exercises on an iPad. The method has been developed for use in patients. Those participating in the study will be asked to perform this test at the outpatient clinic a few days before surgery and one day after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypercapnia | Other | PaCO2: 6.4-7.0 kPa |
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| Normocapnia | Other | PaCO2: 5.0-5.5 kPa |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventilation strategy | Other | The selected PaCO2 targets are: Normocapnia: PaCO2: 5.0-5.5 kPa Hypercapnia: PaCO2: 6.4-7.0 kPa The adjustments on the ventilator needed to achieve these targets will be administered by the anesthetic nurse and attending anesthesiologist and held within the following limitations: Tidal volume: 4 - 8ml ml/kg IBW Inspiratory pressure 5-30 cm H2O Respiration rate 10-18 per minute PEEP 5-10 mmHg *IBW: 50 + 0.91 (height in centimeters - 152.4) Peep, I:E ratio, and FiO2 will be administered at the anesthetic nurse's and the anesthesiologist's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| ICA flow | Changes in cerebral blood flow (ml/s) during surgery | day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive performance | Measurements of cognitive performance by CANTAB tests (Cambridge Cognition, England) | 5 days pre-surgery and 1 day post-surgery |
| Cerebral perfusion pressure | Estimated ICP (mmHg) minus Mean arterial pressure (mmHg). |
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Inclusion Criteria: Males 55-80 years old, accepted by surgeon and attending anesthesiologist for RALP surgery.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Signe Søvik, Professor, MD, PhD | University Hospital, Akershus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital | Lørenskog | 1478 | Norway |
Any sharing of patient-level data from this study would have to be pre-approved by the Regional Committee for Medical and Health Research Ethics in South-Eastern Norway as well as by the Personal Data Protection Officer at Akershus University Hospital
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Clinical double blinded randomized interventional study
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The participant and investigator are blinded. The anesthesia providers are not blinded.
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| Day of surgery |
| Cardiac index (L/min) | Measured by LidCO arterial pulse contour analysis | Day of surgery |
| ID | Term |
|---|---|
| D000079690 | Postoperative Cognitive Complications |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D060825 | Cognitive Dysfunction |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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