Phase 1
N=52
Nicardipine vs Esmolol Craniotomy Emergence
Brain Tumors
Bottom Line
View on ClinicalTrials.gov: NCT01951950 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Failure of Drug to Control Systolic Blood Pressure (SBP) < 140 mmHg — 1; 11 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Nicardipine (Drug); Esmolol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Failure of Drug to Control Systolic Blood Pressure (SBP) < 140 mmHg |
1; 11 | — |
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.
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
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.