Phase 1 Completed N=52 Randomized Treatment

Nicardipine vs Esmolol Craniotomy Emergence

brain tumor

Source: ClinicalTrials.gov NCT01951950 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcomePrimary: Failure of Drug to Control Systolic Blood Pressure (SBP) < 140 mmHg — 1; 11 participants

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Failure of Drug to Control Systolic Blood Pressure (SBP) < 140 mmHg	1; 11	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01951950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.