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Clinical Trials/NCT01752959
NCT01752959UnknownPhase 4

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

Diskapi Teaching and Research Hospital1 site in 1 country60 target enrollmentStarted: July 2012Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Enrollment
60
Locations
1
Primary Endpoint
the difference between group regarding blood loss

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
None

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

esmolol

Experimental

Grup E 500 micg/kg/min lading dose after 50-500 μcg/kg/dk esmolol infusion

Intervention: Esmolol (Drug)

Remifentanyl

Active Comparator

Group R 0.1-0.3 mic/kg/ min remifentanil infusion other names: Ultiva

Intervention: Remifentanil (Drug)

Outcomes

Primary Outcomes

the difference between group regarding blood loss

Time Frame: intraoperative

controlled hypotension in nasal surgery

Secondary Outcomes

  • the difference between groups regarding side effects and treatments(intraoperative)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dondu Ruveyda Acikgoz

Medical Doctor Trainee in Anesthesiology and Reanimation

Diskapi Teaching and Research Hospital

Study Sites (1)

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