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A Comparison of Esmolol and Remifentanil to Reduce Blood Loss

D

Diskapi Teaching and Research Hospital

Status and phase

Unknown
Phase 4

Conditions

Deviation Septum Nasal

Treatments

Drug: Remifentanil
Drug: Esmolol

Study type

Interventional

Funder types

Other

Identifiers

NCT01752959
RAcikgozEsmolol

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No 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

Trial design

60 participants in 2 patient groups

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

Trial contacts and locations

2

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Central trial contact

Ruveyda D Acikgoz, Trainee; Dilek Yazicioglu, Specialist

Data sourced from clinicaltrials.gov

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