A Comparison of Esmolol and Remifentanil to Reduce Blood Loss

Phase 4

• Conditions: Deviation Septum Nasal
• Interventions: Drug: Remifentanil; Drug: Esmolol

• Registration Number: NCT01752959
• Lead Sponsor: Diskapi Teaching and Research Hospital

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

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 Timeline

• Study Start: 2012-07
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2012-12-04
• Study First Submitted QC: 2012-12-17
• Last Update Submitted: 2012-12-17
• Study First Posted: 2012-12-19
• Last Update Posted: 2012-12-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remifentanyl	Remifentanil	Group R 0.1-0.3 mic/kg/ min remifentanil infusion other names: Ultiva
esmolol	Esmolol	Grup E 500 micg/kg/min lading dose after 50-500 μcg/kg/dk esmolol infusion

Primary Outcome Measures

Name	Time	Method
the difference between group regarding blood loss	intraoperative	controlled hypotension in nasal surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Diskapi Yildirim Beyazit Training and Research Hospital; 🇹🇷 Ankara, Turkey