Arterial Pressure and Surgical Hemostasis in Elective Neurosurgery.

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Arterial Pressure and Surgical Hemostasis in Elective Neurosurgery.

Study Purpose

The objective of this observational study is to examine the impact of augmented arterial pressure during the hemostatic phase of elective supratentorial neurosurgery. The primary inquiries it seeks to address are as follows: 1. Does an increase in systolic arterial pressure prompt a hemostatic maneuver by the neurosurgeon, and does the concomitant mean arterial pressure value influence the frequency of such interventions? 2. How often do postoperative intracranial hemorrhages occur, and how severe are they in relation to the achieved mean arterial pressure value? Participants will be enrolled during the preoperative evaluation, where their arterial pressure values, medical histories, and medication statuses will be recorded. Throughout the induction and maintenance of anesthesia, we will monitor their blood pressure values and document any instances of hypotension or hypertension. During the hemostatic phase, we will elevate the arterial pressure using noradrenaline by up to 10 mmHg above the recorded pressure measured at the inpatient clinic. Subsequently, we will inquire whether the neurosurgeon had to employ any additional hemostatic maneuvers following the increase in arterial pressure. The arterial pressure values will be recorded at the end of the surgery, and the first postoperative CT scan will be examined to identify any cases of intracranial hemorrhage.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- All consecutive adult patients scheduled to undergo elective supratentorial neurosurgical surgery.

Exclusion criteria:

- Urgent or emergent surgery.

- Neurovascular surgery.

- Subtentorial surgery.

- Trans nasal approaches.

- Back surgery.

- Acute or chronic kidney injury as defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (Kellum & Lameire, 2013; Stevens & Levin, 2013) - Coagulation derangement (platelet count < 100*10^9/L, international normalized ratio (INR) or activated partial thromboplastin time (aPTT) > 1.5 times the normal laboratory range) or anticoagulant/antiplatelet treatment without appropriate withhold intervals, as per existing guidelines.

- Preoperative severe hemodynamic instability, according to the judgment of the attending physician.

- Age < 18 years.

- Pregnancy or breastfeeding.

- Absence of informed consent

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05874050
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Marco Fabio Gemma, Dr
Principal Investigator Affiliation	Fondazione IRCCS Istituto Neurologico Carlo Besta Milan, Italy
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neurosurgery, Intracranial Hemorrhages, Supratentorial Brain Tumor, Blood Pressure

Additional Details

During surgery to remove intracranial tumors, a patient's blood pressure is kept moderately low to facilitate the procedure. Subsequently, a surgical phase of hemostasis is performed. At this stage, the standard clinical practice requires the anesthesiologist to raise blood pressure to challenge the surgical hemostasis. Although this practice may be considered ubiquitous, it is not currently described in neuroanesthesia texts, and no studies are available that report the effect of this maneuver, either in terms of the optimal level of pressure elevation or in terms of the greater efficacy of a target of systolic arterial pressure (SAP) rather than mean arterial pressure (MAP). The most frequently sought increase in everyday clinical practice is about 10 mmHg higher than the first SAP measured in the patient's operating room. Because of the different profiles of brain autoregulation (Smith, 2015) and individual cardiovascular profiles, anticipatory and context anxiety accompanying the time of surgery, in line with the literature, the present study prefers to select the blood pressure value measured on the ward at the time of admission as the reference (Ackland et al., 2019; Ard & Kendale, 2016). The study aims first to observe the effects on the operative field of this increase.

- Primary objective: To verify how frequently the SAP-increasing maneuver prompts the Neurosurgeon to perform a hemostatic maneuver on the surgical field and to evaluate whether the concomitant MAP value reached affects this frequency.

- Secondary objective: To quantify the frequency and severity of any postoperative intracranial hemorrhage in relation to the achieved MAP value.

There are no pharmacological strategies to increase SAP and MAP selectively. However, it can be estimated that the increase mentioned above in SAP, achieved in our institute with an intravenous norepinephrine infusion, is not accompanied by a parallel increase in MAP in about 50 percent of cases (unpublished data).

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