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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02563288 |
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Date of registration:
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19/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Esmolol Versus Dexmedetomidine During Intracranial Procedures
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Scientific title:
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Comparison of Esmolol and Dexmedetomidine on Sympathetic Control During Intracranial Procedures |
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Date of first enrolment:
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August 2016 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02563288 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Greece
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Contacts
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Name:
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Irene Asouhidou, MD, PhD |
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Address:
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Telephone:
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Email:
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iasouh@aol.com |
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Affiliation:
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Name:
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Irene Asouhidou, MD, PhD |
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Address:
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Telephone:
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00302310452560 |
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Email:
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iasouh@aol.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Intracranial Aneurysm
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Intracranial Neoplasms
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Intervention(s)
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Drug: Esmolol
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Drug: Dexmedetomidine
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Primary Outcome(s)
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Systolic arterial pressure- mean arterial pressure (mmHg)
[Time Frame: every 15minutes, starting from the induction in anesthesia through surgery completion and up to first 24 postoperative hours.]
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Secondary ID(s)
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GeorgePapanikolaouHospital
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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