A Comparison of Esmolol and Remifentanil to Reduce Blood Loss
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Remifentanyl Group R 0.1-0.3 mic/kg/ min remifentanil infusion other names: Ultiva |
Drug: Remifentanil
0.1-0.3 micg/kg/min Remifentanil iv infusion
Other Names:
|
| Experimental: esmolol Grup E 500 micg/kg/min lading dose after 50-500 μcg/kg/dk esmolol infusion |
Drug: Esmolol
500 μcg/kg/dk esmolol iv lading dose after 50-500 μcg/kg/dk esmolol iv infusion
Other Names:
|
Outcome Measures
Primary Outcome Measures
- the difference between group regarding blood loss [intraoperative]
controlled hypotension in nasal surgery
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
ASA I-II,
-
between age 20-60
Exclusion Criteria:
-
patients having bleeding disorders,
-
arrhythmia,
-
hypertension,
-
endocrine, liver or kidney disease and
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those who are on antihypertensive,
-
anticoagulant drugs
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Diskapi Yildirim Beyazit Training and Research Hospital | Ankara | Turkey | 06110 | |
| 2 | Diskapi Yildirim Beyazit Training and Research Hospital | Ankara | Turkey | 06610 |
Sponsors and Collaborators
- Diskapi Teaching and Research Hospital
Investigators
- Principal Investigator: Ruveyda D Acıkgoz, Trainee, Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.
Study Documents (Full-Text)
None provided.More Information
Publications
- Degoute CS, Ray MJ, Manchon M, Dubreuil C, Banssillon V. Remifentanil and controlled hypotension; comparison with nitroprusside or esmolol during tympanoplasty. Can J Anaesth. 2001 Jan;48(1):20-7.
- Shen PH, Weitzel EK, Lai JT, Wormald PJ, Ho CS. Intravenous esmolol infusion improves surgical fields during sevoflurane-anesthetized endoscopic sinus surgery: a double-blind, randomized, placebo-controlled trial. Am J Rhinol Allergy. 2011 Nov-Dec;25(6):e208-11. doi: 10.2500/ajra.2011.25.3701.
- RAcikgozEsmolol