A Randomized Comparison of Esmolol and Remifentanil on Intraoperative Bleeding and Surgical Field Conditionsin Nasal Surgery
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
Grup E 500 micg/kg/min lading dose after 50-500 μcg/kg/dk esmolol infusion
Intervention: Esmolol (Drug)
Remifentanyl
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
Dondu Ruveyda Acikgoz
Medical Doctor Trainee in Anesthesiology and Reanimation
Diskapi Teaching and Research Hospital
