Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04266665 |
| Other study ID # |
DexProB |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
March 12, 2020 |
| Est. completion date |
December 15, 2021 |
Study information
| Verified date |
February 2022 |
| Source |
Aristotle University Of Thessaloniki |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Brain tumor surgery is commonly associated with different degrees of preoperative
intracranial hypertension and surrounding tumor edema, elicited by tumor underlying
pathophysiology. During craniotomy for brain tumor resection maintenance of hemodynamic
stability and intracranial homoeostasis is of paramount importance. Disordered hemodynamics
or adverse stress may activate the immune inflammation or neuroendocrine responses and lead
to a surge of inflammatory mediators and stress hormones, which are implicated in secondary
brain insults.
Adverse physiological responses caused by intraoperative disordered hemodynamics or
surgery-related damage, may lead to some secondary brain injury (such as cerebral edema or
cerebral hemorrhage), aggravating damage to brain tissue and affecting the recovery from
anesthesia, cognition and prognosis in patients.
Prevention of secondary brain injury is a key-endpoint to improve clinical outcomes in glioma
patients undergoing craniotomy.
Alpha2-adrenoceptor agonists have been widely used for sedation, analgesia and
anti-sympathetic actions for many years, but the definite evidence of their potential use as
neuroprotectants has so far been confined to animal studies, yet the findings are
inconsistent.
Dexmedetomidine (DEX) has been demonstrated to be a new type a2 adrenergic receptor (a2-AR)
agonist, which can selectively bind with the a1 and a2 adrenergic receptor, and playing a
dual role by restraining the activity of sympathetic nervous and stimulating the vagus nerve.
Dexmedetomidine (DEX) also plays an important role in in inhibiting inflammatory and
neuroendocrine responses. Animal experiments showed that the right must have a
dexmedetomidine neuro-protective effect. However, the brain-protective effect of
dexmedetomidine in anesthesia of craniotomy resection of glioma has not been reported.
Thus, the aim of this study was to explore the effect of dexmedetomidine on perioperative
brain protection, as well as cerebral oxygenation and metabolic status aiming to provide a
basis for clinical rational drug use in patients undergoing craniotomy resection of glioma.
Description:
Each participant will receive standard monitoring (ECG, SpO2, SBP, BIS, urine output,
temperature). More detailed hemodynamic monitoring will be obtained by Edwards Lifesciences
ClearSight system (CO, CI, SV, SVI, SVV, SVR, SVRI).
TCI Propofol and Remifentanil will be the agents of choice for induction and maintenance in
anesthesia and cisatracurium will be used for neuromuscular blockade for intubation.
Protective mechanical ventilation will be chosen (7ml/kg IBW) with a respiratory rate to
obtain a PaCO2 of 35-40 mmHg. PEEP will be changed for the best PaO2/FiO2 ratio and FiO2 of
choice will be 0.5.
The radial artery catheterization will be applied for direct blood pressure measurement and
arterial blood gas sampling (pH, PaO2, PaCO2, HCO3, BE, osmolality, lactic acid, Hb, glucose,
Na and K will be measured).
The jugular bulb ipsilateral to the craniotomy site will be catheterized for receiving blood
samples for blood gas analysis. The following oxygenation and metabolic parameters /
derivates will be measured or calculated: SjvO2, pH, PjvO2, PjvCO2, HCO3, BE, Osmolality,
Lactic acid jv, Hb, Glucose, Na, K, AjvDO2, AjvCO2, O2ERbr, eRQbr, AjvDL, and LOI.
Dexmedetomidine or normal saline (placebo) administration will start 10 minutes after
anesthesia induction and maintained throughout the surgical procedure.
Phases
- T0: 5 minutes before administration of either DEX or placebo
- T15: 10 minutes after administration of either DEX or placebo
- T30: 30 minutes after administration of either DEX or placebo
- T60: 60 minutes after administration of either DEX or placebo
- T120: 120 minutes after administration of either DEX or placebo
- T240: 240 minutes after administration of either DEX or placebo
- End of surgical procedure Blood samples for measuring S-100b, NSE, cortisol, TNF-a and
IL-6 will be obtained at phases T0, end of surgery and 24 hours after administration of
either DEX or placebo.
Neurocognitive testing will be performed before surgery, 1 week and 1 month later using
Karnofsky Performance Status (KFS), Mini Mental State Exam (MMSE), Μontreal Cognitive
Assessment (MoCA) and Addenbrooke's Cognitive Exam (ACE III).
Intraoperative consumption of propofol and remifentanil will also be recorded
