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

In this prospective randomized study we aimed to compare the effects of esmolol and remifentanil on intraoperative bleeding surgical field conditions in nasal surgery

Study Overview

• Status: Unknown
• Conditions: Deviation Septum Nasal
• Intervention / Treatment: Drug: Remifentanil; Drug: Esmolol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ruveyda D Acikgoz, Trainee; Phone Number: 0903125962554
• Study Contact Backup: Name: Dilek Yazicioglu, Specialist; Phone Number: 0903125962553; Email: dilek.yazicioglu@hotmail.com

Study Locations

• Turkey
  • Ankara, Turkey, 06110
    • Completed
    • Diskapi Yildirim Beyazit Training and Research Hospital
  • Ankara, Turkey, 06610
    • Recruiting
    • Diskapi Yildirim Beyazit Training and Research Hospital
    • Contact: Murat Alper, Proffesor; Phone Number: 03125962242; Email: muratalper@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Remifentanyl; Group R 0.1-0.3 mic/kg/ min remifentanil infusion other names: Ultiva	Drug: Remifentanil; 0.1-0.3 micg/kg/min Remifentanil iv infusion; Other Names: Ultiva
Experimental: esmolol; Grup E 500 micg/kg/min lading dose after 50-500 μcg/kg/dk esmolol infusion	Drug: Esmolol; 500 μcg/kg/dk esmolol iv lading dose after 50-500 μcg/kg/dk esmolol iv infusion; Other Names: Brevibloc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the difference between group regarding blood loss	controlled hypotension in nasal surgery	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the difference between groups regarding side effects and treatments	side effects: more than 20% change in blood pressure and heart rate, treatment includes atropin, ephedrin, nitroglyserine	intraoperative

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital
• Investigators: Principal Investigator: Ruveyda D Acıkgoz, Trainee, Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.

Publications and helpful links

General 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. doi: 10.1007/BF03019809.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: December 4, 2012
• First Submitted That Met QC Criteria: December 17, 2012
• First Posted (Estimate): December 19, 2012

Study Record Updates

• Last Update Posted (Estimate): December 19, 2012
• Last Update Submitted That Met QC Criteria: December 17, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Adrenergic beta-1 Receptor Antagonists; Remifentanil; Esmolol
• Other Study ID Numbers: RAcikgozEsmolol