A Comparison of Esmolol and Remifentanil to Reduce Blood Loss

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

Detailed Description
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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.

Official Title
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A Randomized Comparison of Esmolol and Remifentanil on Intraoperative Bleeding and Surgical Field Conditionsin Nasal Surgery

Conditions
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Deviation Septum Nasal

Intervention / Treatment
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* Drug: Remifentanil
* Drug: Esmolol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |