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Completed

NCT Number: NCT01951950

Nicardipine vs Esmolol Craniotomy Emergence

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult
  • non-pregnant patients
  • (age ≥ 18 years)
  • undergoing general anesthesia for elective supratentorial, infratentorial, or transsphenoidal craniotomy

Exclusion criteria

  • Patients under 18 years of age
  • non-English speaking, pregnancy
  • emergent craniotomy (including trauma)
  • awake craniotomy
  • active 3 vessel coronary artery disease or left main coronary artery disease
  • advanced heart block
  • severe aortic stenosis
  • chronic renal failure
  • known or suspected allergy or intolerance to a study drug or its components

Treatment and study plan

nicardipine

Drug

esmolol

Drug

Primary outcomes

  1. Failure of Drug to Control Systolic Blood Pressure (SBP) < 140 mmHg

    Time frame: 1 hour postoperatively

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Nicardipine Versus Esmolol for Management of Emergence Hypertension After Craniotomy

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 27, 2013
Registry last updated
Aug 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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