Hypertension and Cerebrovascular Hemodynamics in General Anaesthesia
NCT06855407 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-03-13
Summary
During anesthesia, blood pressure-raising medications are often required to achieve an adequate blood pressure level. However, there is limited knowledge about what constitutes an adequate blood pressure to ensure sufficient blood flow to the brain. This project aims to map the relationship between blood pressure and brain blood flow using an MRI scanner. The results will contribute to a better understanding of this relationship and lead to improved management of brain blood flow during surgery on anesthetized patients.
How does the project work?
Day 1 Before planned surgery, participants will meet with an anesthesiologist for information and assessment. An MRI scan of the brain will be conducted while participants are awake. The MRI examination has no side effects or risks. The space inside the MRI scanner is tight, especially around the head. If discomfort is experienced, the examination will be stopped immediately. The machine is noisy, so hearing protection will be provided, and communication with staff will be possible throughout the examination. The scan takes approximately 30 minutes, during which participants only need to lie still and relax.
Day 2 After planned surgery, an anesthesiologist and an anesthesia nurse will transfer participants to the MRI scanner while still under anesthesia. Participants will not be woken up between surgery and the MRI scan; instead, transportation will occur while still anesthetized, following standard hospital procedures.
Participants will remain under the same anesthetic drugs as during the surgery. The same blood pressure-raising medication, norepinephrine, will be continuously used.
No additional drugs, beyond those necessary for normal anesthesia, will be administered before the MRI examination.
The entire project will take about 1.5 hours in addition to the surgery. If an arterial catheter (a blood pressure monitor via an artery in the wrist) is not already in place, one will be inserted while participants are asleep.
Before the MRI examination:
Baseline examination - If any abnormalities are detected, the scan will be stopped, and follow-up by a doctor will occur.
Blood pressure increase - Blood pressure will be raised by approximately 30% (equivalent to mild physical activity, such as jogging).
Follow-up scan at the higher blood pressure level. Blood pressure returns to normal. All blood pressure levels will remain within clinically acceptable ranges for anesthetized patients and will be regulated with the same medication as used during the surgery.
After the MRI:
Participants will be woken up in the anesthesia preparation room next to the MRI scanner.
The arterial catheter will be removed before awakening. Participants will be transported to the postoperative unit for monitoring. The surgeon responsible for care will determine the discharge time.
Possible Risks and Side Effects of Participation
Transporting an anesthetized patient for an MRI scan outside the operating room carries some risks. However, the hospital has established procedures for daily transportation of anesthetized patients and a structured division of responsibilities to manage unexpected situations. Monitoring will be conducted by an experienced anesthesiologist and anesthesia nurse throughout the procedure.
Routine monitoring includes blood pressure, heart rate, depth of anesthesia, and oxygen levels.
No long-term effects have been observed from MRI scans or short-term anesthesia for these examinations.
Most complications related to general anesthesia occur during induction or awakening, and these risks exist regardless of study participation.
Study participation may slightly increase the risk of IV lines or breathing tubes becoming dislodged due to movement while anesthetized.
A prolonged period under anesthesia may cause slight additional fatigue upon waking.
To ensure understanding of the information about this study, participants will take a simple cognitive test (5 minutes) before surgery.
If any unexpected complications arise during surgery, study participation will be discontinued. If the MRI scan reveals any abnormalities, referral to a neurologist or neurosurgeon for further evaluation will be provided.
What Happens to Collected Data?
The project will collect health information from medical records and MRI scans. All data will be pseudonymized (coded) so that it cannot be linked to individual participants.
The key to decoding this information will be stored securely by the research nurse at the Neuro-Head-Neck Center (NHHC).
Only authorized research personnel will have access to the pseudonymized data. Information will be protected in accordance with the General Data Protection Regulation (GDPR).
Conditions
- Anesthesia
- Cerebral Blood Flow
- Regional Cerebral Oxygen Saturation
- Blood Pressure
Interventions
- OTHER
-
Blood pressure elevation
Increasing systemic blood pressure for measurement of cerebral blood flow changes
Sponsors & Collaborators
-
Region Västerbotten
collaborator OTHER_GOV -
Umeå University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-12-06
- Primary Completion
- 2026-12-06
- Completion
- 2027-06-01
Countries
- Sweden
Study Locations
More Related Trials
-
The Effect of Blood Pressure on Cerebral Perfusion During Vascular Surgery
NCT02531139 ·Status: WITHDRAWN ·Phase: NA
-
Decision Support for Intraoperative Low Blood Pressure
NCT02726620 ·Status: COMPLETED ·Phase: NA
-
Predicting If the Blood Pressure Will Drop After Spinal Anesthesia Using Ultrasound of the Neck
NCT06711289 ·Status: COMPLETED
-
Ability of Carotid Sonography and Inferior Vena Cava Sonography for the Prediction of Post-induction Hypotension in Hypertensive Patients
NCT03986112 ·Status: UNKNOWN
-
Cerebral Perfusion Variation During Blood Pressure Changes in ICU
NCT05804773 ·Status: RECRUITING
-
Hypotensive Effect of Anaesthesia With TCI
NCT02733406 ·Status: COMPLETED ·Phase: NA
-
Cerebral Perfusion During Induction of General Anesthesia
NCT03769142 ·Status: COMPLETED
-
Cervical Cord Compression and Hypertension
NCT04345822 ·Status: UNKNOWN
-
Brain Autoregulation Research Study
NCT07221721 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Hemodynamic Changes of Upper and Lower Extremities After Spinal Anesthesia
NCT01003561 ·Status: UNKNOWN ·Phase: NA
-
Effect of High vs. Low MAP Levels on Clinical Outcomes in Elderly Patients During Noncardiothoracic Surgery
NCT02857153 ·Status: UNKNOWN ·Phase: NA
-
Quantification of Dynamic and Static Cerebral Autoregulation (CA) Under Anaesthesia
NCT03816072 ·Status: COMPLETED ·Phase: NA
-
Correlation Between Dorsalis Pedis and Radial Arterial Invasive Blood Pressures During Anesthesia Induction in Neurosurgical Patients
NCT04469751 ·Status: COMPLETED ·Phase: NA
-
Carotis cFT In Prediction Of Hypotension
NCT05896514 ·Status: COMPLETED
-
Parameters of Cerebral Perfusion
NCT02806492 ·Status: COMPLETED ·Phase: NA
-
Predictability of the Pulse Pressure Variation (PPV) During Spontaneous Ventilation on the Incidence of Hypotension During Induction of Anesthesia
NCT02208570 ·Status: UNKNOWN ·Phase: NA
-
Pre-warmed Intravenous Fluids and Monitored Anesthesia Care
NCT01722955 ·Status: COMPLETED ·Phase: NA
-
Norepinephrine Prevent Post-induction Hypotension in High-risk Patients
NCT06028256 ·Status: UNKNOWN ·Phase: PHASE4
-
Monitoring Hypertensive Patients's Cerebral Oxygen Saturation
NCT02147275 ·Status: COMPLETED
-
Effects of Continuous Noninvasive Arterial Pressure Measurement on Anaesthesia
NCT02519101 ·Status: COMPLETED ·Phase: NA
-
Vegetative Monitoring During Brainstem-associated Surgery
NCT03666507 ·Status: COMPLETED
-
Comparison of Blood Pressure Measurements in Upper and Lower Extremities in Children Under General Anesthesia
NCT03220906 ·Status: COMPLETED
-
Changes in the Microvascular Reactivity on Leg During Spinal Anesthesia
NCT04806997 ·Status: COMPLETED
-
Assessment of Cerebral Blood Flow Asymmetry in Cardiac Surgery Patients Undergoing Hypothermic Circulatory Arrest
NCT03215589 ·Status: TERMINATED
-
Ultrasound Assessment of the Subclavian Vein for Predicting Hypotension in Children After Anaesthesia Induction
NCT04573842 ·Status: COMPLETED