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Esmolol Versus Dexmedetomidine During Intracranial Procedures

Comparison of Esmolol and Dexmedetomidine on Sympathetic Control During Intracranial Procedures

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02563288
Enrollment
60
Registered
2015-09-30
Start date
2016-08-31
Completion date
2017-10-31
Last updated
2017-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Aneurysm, Intracranial Neoplasms

Keywords

esmolol, dexmedetomidine, opioids

Brief summary

Patients undergoing intracranial procedures may experience severe hypertension and tachycardia due to intracranial hypertension and to increased release of adrenaline. Preventing perioperative sympathetic activity is of great importance. A common technique is using b-blockers like esmolol, which effectively block perioperative hemodynamic changes during intracranial surgery. A2 agonists, like Dexmedetomidine-Dex are now being used as a component of a balanced anesthesia during neurosurgical procedures. This study aimed to evaluate whether esmolol or dex attenuates perioperative changes in patients undergoing elective craniotomy with fast track neuroanesthesia.

Detailed description

Patients scheduled for elective craniotomy are randomized to receive Dex 1γ/Kg over 10 minutes following by continuous infusion of Dex 0.7γ/Kg (group D) or esmolol 500mcg/Kg over 5 min following by continuous infusion of 300mcg/Kg/min (group E). Patients in both groups are subjected to a standardized anesthesia comprising of induction with propofol, fentanyl, rocuronium, and maintained with Oxygen-air: 1/1, sevoflurane and bolus fentanyl in order to access the same level of anesthesia (BIS 40-50). The hemodynamic variables at various stages of surgery (HR-heart rate, MAP-Mean arterial pressure) and recovery characteristics are also recorded. It is also performed monitoring of cerebral oximetry (INVOS).

Interventions

DRUGEsmolol

effect of esmolol on intraoperative sympathetic control and on extubation conditions.

DRUGDexmedetomidine

effect of dexmedetomidine on intraoperative sympathetic control and on extubation conditions.

Sponsors

George Papanicolaou Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients with ASA physical status 1-3 * Glasgow Coma Scale:13-15 * Hunt-Hess: 0-3

Exclusion criteria

* Patients with ASA physical status \>3, * Body Mass Index (BMI) over 30, * indication for rapid sequence induction, * any contraindication for receiving b-blocker, * Glasgow Coma Scale (GCS) \<13, * history of drug abuse, * neurologic deficit or preoperatively foreseen delayed extubation, * preoperative heart rate\<45.

Design outcomes

Primary

MeasureTime frameDescription
Systolic arterial pressure- mean arterial pressure (mmHg)every 15minutes, starting from the induction in anesthesia through surgery completion and up to first 24 postoperative hours.Status of patients during emerge from anaesthesia after intracranial surgery

Countries

Greece

Contacts

Primary ContactIrene Asouhidou, MD, PhD
iasouh@aol.com
Backup ContactDimitris Zosimidis, MD
d.zosimidis@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026