A Comparison of Esmolol and Remifentanil to Reduce Blood Loss
A Randomized Comparison of Esmolol and Remifentanil on Intraoperative Bleeding and Surgical Field Conditionsin Nasal Surgery
1 other identifier
interventional
60
1 country
2
Brief Summary
In this prospective randomized study we aimed to compare the effects of esmolol and remifentanil on intraoperative bleeding surgical field conditions in nasal surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2012
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 4, 2012
CompletedFirst Posted
Study publicly available on registry
December 19, 2012
CompletedDecember 19, 2012
December 1, 2012
5 months
December 4, 2012
December 17, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
the difference between group regarding blood loss
controlled hypotension in nasal surgery
intraoperative
Secondary Outcomes (1)
the difference between groups regarding side effects and treatments
intraoperative
Study Arms (2)
Remifentanyl
ACTIVE COMPARATORGroup R 0.1-0.3 mic/kg/ min remifentanil infusion other names: Ultiva
esmolol
EXPERIMENTALGrup E 500 micg/kg/min lading dose after 50-500 μcg/kg/dk esmolol infusion
Interventions
500 μcg/kg/dk esmolol iv lading dose after 50-500 μcg/kg/dk esmolol iv infusion
Eligibility Criteria
You may qualify if:
- ASA I-II,
- between age 20-60
You may not qualify if:
- patients having bleeding disorders,
- arrhythmia,
- hypertension,
- endocrine, liver or kidney disease and
- those who are on antihypertensive,
- anticoagulant drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, 06110, Turkey (Türkiye)
Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, 06610, Turkey (Türkiye)
Related Publications (2)
Degoute CS, Ray MJ, Manchon M, Dubreuil C, Banssillon V. Remifentanil and controlled hypotension; comparison with nitroprusside or esmolol during tympanoplasty. Can J Anaesth. 2001 Jan;48(1):20-7. doi: 10.1007/BF03019809.
PMID: 11212044BACKGROUNDShen PH, Weitzel EK, Lai JT, Wormald PJ, Ho CS. Intravenous esmolol infusion improves surgical fields during sevoflurane-anesthetized endoscopic sinus surgery: a double-blind, randomized, placebo-controlled trial. Am J Rhinol Allergy. 2011 Nov-Dec;25(6):e208-11. doi: 10.2500/ajra.2011.25.3701.
PMID: 22185726BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruveyda D Acıkgoz, Trainee
Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor Trainee in Anesthesiology and Reanimation
Study Record Dates
First Submitted
December 4, 2012
First Posted
December 19, 2012
Study Start
July 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
December 19, 2012
Record last verified: 2012-12