Clinical trial · Observational
Arterial Pressure and Surgical Hemostasis in Elective Neurosurgery.
The Effect of Arterial Pressure on Surgical Hemostasis During Elective Supratentorial Neurosurgery: a Prospective Observational Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blood Pressure | — | UNRESOLVED | — |
| Intracranial Hemorrhages | — | UNRESOLVED | — |
| Neurosurgery | — | UNRESOLVED | — |
| Supratentorial Brain Tumor | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Frequency of need for hemostatic maneuver in the neurosurgical field
- timeFrame
- During surgery
- description
- The investigators document the frequency with which the primary operators indicate the need for additional maneuvers once the target systolic arterial pressure (SAP) exceeds a 10 mmHg (millimetres of mercury ) increase from the baseline relative to the achieved mean arterial pressure (MAP) value.
- measure
- Number of postoperative neurosurgical site hemorrhage requiring treatment
- timeFrame
- In the 24 hours after surgery
- description
- In relation to the MAP value achieved, the investigators register the number of times the presence of a neurosurgical site hemorrhage calls for a novel surgical treatment or significant therapy adjustments.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available