Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT01752959
Status:
UNKNOWN
Last Update Posted:
2012-12-19
First Post:
2012-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Esmolol and Remifentanil to Reduce Blood Loss
Sponsor:
Diskapi Teaching and Research Hospital
Organization:
Study Overview
Official Title:
A Randomized Comparison of Esmolol and Remifentanil on Intraoperative Bleeding and Surgical Field Conditionsin Nasal Surgery
Status:
UNKNOWN
Status Verified Date:
2012-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: