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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01752959

Enrollment

Registered

2012-12-19

Start date

2012-07-31

Completion date

2012-12-31

Last updated

2012-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deviation Septum Nasal

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.

Interventions

DRUGRemifentanil

0.1-0.3 micg/kg/min Remifentanil iv infusion

DRUGEsmolol

500 μcg/kg/dk esmolol iv lading dose after 50-500 μcg/kg/dk esmolol iv infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Turkey (Türkiye)

Contacts

Primary ContactRuveyda D Acikgoz, Trainee

0903125962554

Backup ContactDilek Yazicioglu, Specialist

dilek.yazicioglu@hotmail.com0903125962553

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026