A Comparison of Esmolol and Remifentanil to Reduce Blood Loss
Information source: Diskapi Teaching and Research Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Deviation Septum Nasal
Intervention: Remifentanil (Drug); Esmolol (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Diskapi Teaching and Research Hospital Official(s) and/or principal investigator(s): Ruveyda D Acıkgoz, Trainee, Principal Investigator, Affiliation: Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.
Overall contact: Ruveyda D Acikgoz, Trainee, Phone: 0903125962554
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
Clinical Details
Official title: A Randomized Comparison of Esmolol and Remifentanil on Intraoperative Bleeding and Surgical Field Conditionsin Nasal Surgery
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: the difference between group regarding blood loss
Secondary outcome: the difference between groups regarding side effects and treatments
Detailed description:
60 patients with ASA I-IIphysical status assigned for septoplasty will be enrolled in this
prospective randomized trial. A standardized anesthesia induction and intubation with
propofol and rocuronium will be used. Patients will be randomized in two groups. Group
Esmolol (Group E n=30) will receive esmolol 500 mic kg-1 loading dose and a 50-500 mic kg-1
min-1 infusion and Group Remifentanil (Group R n=30) will receive remifentanil 0. 1-0. 3 mic
kg-1 min-1 infusion to induce controlled hypotension. A 50-60 mmHg mean arterial pressure
and a minimum 50 beat min-1 heart rate is targeted. Heart rate, blood pressures, peripheral
oxygen saturation and bispectral index spectrum (BIS) will be recorded. Anesthesia
maintenance will be provided with O2/N2O and desflurane-propofol balanced anesthesia and a
BIS value 40-60 is targeted. The quality of the surgical field will be assessed by the
surgeon by using a 10 point visual analog scale (B1) and a 6 point scale (B2) during surgery
with 5 minute intervals. The amount of bleeding will be calculated at the end of surgery
from the amount of blood and irrigation fluid collected in the suction tube. All
complications and side effects will be recorded.
Eligibility
Minimum age: 20 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- ASA I-II,
- between age 20-60
Exclusion Criteria:
- patients having bleeding disorders,
- arrhythmia,
- hypertension,
- endocrine, liver or kidney disease and
- those who are on antihypertensive,
- anticoagulant drugs
Locations and Contacts
Ruveyda D Acikgoz, Trainee, Phone: 0903125962554
Diskapi Yildirim Beyazit Training and Research Hospital, Ankara 06110, Turkey; Completed
Diskapi Yildirim Beyazit Training and Research Hospital, Ankara 06610, Turkey; Recruiting Murat Alper, Proffesor, Phone: 03125962242, Email: muratalper@hotmail.com
Additional Information
Related publications: 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. Shen 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.
Starting date: July 2012
Last updated: December 17, 2012
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