Brain Tumors Clinical Trial
Official title:
Nicardipine Versus Esmolol for Management of Emergence Hypertension After Craniotomy
Emergence hypertension is a common occurrence in patients emerging from general anesthesia.
This elevation of arterial pressure is particularly concerning in patients undergoing
craniotomy due to increased risk of morbidity and mortality in patients with altered
intracranial elastance. Thus, identifying better methods to attenuate the hemodynamic
changes associated with emergence from anesthesia can improve patient safety, especially in
the neurosurgical patient.
Study Hypothesis: Nicardipine is more effective than esmolol as a sole agent in maintaining
blood pressure within goal range in the setting of emergence hypertension after craniotomy.
Emergence hypertension following craniotomy is a well-described, albeit poorly understood,
phenomenon. Strict control of blood pressure is of utmost importance during and after
neurosurgical procedures; failure to prevent acute rises in arterial blood pressure places
patients at increased risk of intracranial bleeding, cerebral edema, increased intracranial
pressure, and prolonged hospital stays. Emergence hypertension after craniotomy seems to be
the result of an acute and transient increase in catecholamine release, peripheral
vasoconstriction, and reduced baroreceptor sensitivity. Prior investigations have
demonstrated that treatment with antihypertensive agents is required in 60 to 90% of
neurosurgical patients postoperatively. Given the common occurrence of emergence
hypertension after craniotomy and the increased risk of potentially devastating events that
may occur in the setting of acute increases in arterial blood pressure, it is important to
identify how best to manage these hemodynamic changes.
An ideal drug for the management of emergence hypertension would be a short-acting,
parenteral drug that is easily and rapidly titratable. Medications commonly utilized include
nicardipine, labetolol, and esmolol. When given as a bolus, nicardipine, a calcium channel
blocker, demonstrates a maximal response in <2 minutes and a mean half-life of approximately
40 minutes. Nicardipine is also frequently administered as an infusion; however, time to
onset is increased if no bolus is administered and duration of action may be 4-6 hours after
prolonged infusion. Labetolol, a non-selective beta-blocker, demonstrates onset in 10-20
seconds with peak activity at 5 minutes. Esmolol is an ultra-short-acting, B1-beta-blocker
that has rapid onset and is quickly metabolized by nonspecific red blood cell esterases;
however, esmolol primarily results in decreased heart rate and demonstrates less effect on
blood pressure.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02846038 -
Understanding Communication in Healthcare to Achieve Trust (U-CHAT)
|
||
Completed |
NCT02537106 -
A Comparison of the Effect of 1.5 Versus 3% NaCl on Brain Relaxation and Microcirculation
|
N/A | |
Completed |
NCT01222780 -
To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer
|
Phase 1 | |
Completed |
NCT00873184 -
Study of Massage Therapy Within a Brain Tumor Setting
|
N/A | |
Active, not recruiting |
NCT01115777 -
Prospective Assessment of Quality of Life (QOL) in Pediatric Patients Treated With Radiation Therapy for Brain Tumors and Non-central Nervous System (Non-CNS) Malignancies
|
||
Completed |
NCT00003935 -
Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma
|
Phase 1 | |
Completed |
NCT00724191 -
Evaluation of Human Brain Tumor Therapy Response by Magnetic Resonance (MR)
|
||
Recruiting |
NCT04128306 -
Brain Areas of Time-To-Contact Perception: an Awake Surgery Study
|
N/A | |
Recruiting |
NCT05202899 -
Effect of Sugammadex for Reversal of Rocuronium-induced Neuromuscular Block on Perioperative Management of Awake Craniotomy
|
Phase 4 | |
Completed |
NCT00707343 -
[F-18] Fluorothymidine (FLT) Imaging on Patients With Primary Brain Tumors
|
Phase 1 | |
Completed |
NCT00850278 -
Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors
|
N/A | |
Terminated |
NCT00107471 -
Topotecan, G-CSF, and Radiation Therapy in Treating Young Patients With Newly Diagnosed Brain Stem Glioma
|
Phase 1/Phase 2 | |
Completed |
NCT00528437 -
Temozolomide,Thiotepa and Carboplatin With Autologous Stem Cell Rescue Followed by 13-cis-retinoic Acid in Patients With Recurrent/Refractory Malignant Brain Tumors
|
Phase 2 | |
Completed |
NCT00187174 -
Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors
|
Phase 1 | |
Completed |
NCT00135876 -
Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients
|
Phase 3 | |
Completed |
NCT00062478 -
Study of Karenitecin (BNP1350) in Patients With Brain Tumors
|
Phase 2 | |
Completed |
NCT00241670 -
Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid
|
Phase 3 | |
Not yet recruiting |
NCT01445691 -
More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery
|
Phase 2 | |
Terminated |
NCT01018290 -
Navigated Transcranial Magnetic Stimulation in Tumor Surgery
|
N/A | |
Completed |
NCT00003573 -
Etoposide Plus Radiation Therapy Followed by Combination Chemotherapy in Treating Children With Newly Diagnosed Advanced Medulloblastoma
|
Phase 2 |