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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 Ac─▒kgoz, 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

Page last updated: August 23, 2015

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