This study compares remifentanil infusion versus nicardipine infusion for controlled hypotension during elective nasal surgery. Both agents are standard clinical methods. The study evaluates hemodynamic stability, surgical field quality (Fromme-Boezaart score), tissue perfusion, intraoperative blood loss, surgeon satisfaction, and perioperative adverse effects.
This is a prospective, randomized, controlled, parallel-group, single-blind (outcomes assessor-blinded) clinical study. Forty-four patients (ASA I-II, age \>18) undergoing elective nasal surgery will be randomized 1:1 using a computer-based random number generator with sealed envelope allocation. The intervention group will receive nicardipine infusion; the control group will receive remifentanil infusion. Both are standard controlled hypotension methods used routinely at our institution. Hemodynamic parameters will be recorded at seven predefined time points. All perioperative measurements will be recorded by an independent blinded assessor. Statistical analysis: SPSS v24.0, p ≤ 0.05.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
44
Nicardipine infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery. Standard institutional protocol applied.
Remifentanil infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery. Standard institutional protocol applied.
Surgical Field Quality
Intraoperative surgical field visibility assessed by the surgeon using the Fromme-Boezaart Bleeding Scale (scale 0-5; 0 = no bleeding, cadaveric field; 5 = severe bleeding, surgery not possible; lower scores indicate better surgical field)
Time frame: Intraoperative period, approximately up to 3 hours
Extubation Time
Time from discontinuation of anesthetic agents to successful extubation (minutes)
Time frame: End of surgery through extubation, approximately up to 30 minutes
Time Spent Within Target MAP Range
Duration of intraoperative period during which mean arterial pressure remained within the target range of 55-65 mmHg (minutes)
Time frame: Intraoperative period, approximately up to 2 hours
Aldrete Recovery Score
Postoperative recovery assessed using the Aldrete Score (scale 0-10; higher scores indicate better recovery; score ≥ 9 required for PACU discharge)
Time frame: At 15 and 30 minutes post-extubation, up to 2 hours
Time to PACU Discharge
Time from arrival to PACU to meeting discharge criteria (minutes)
Time frame: Post-extubation through PACU discharge, up to 2 hours
Heart Rate
Intraoperative heart rate monitored via standard ECG (beats per minute)
Time frame: Intraoperative period, approximately up to 2 hours
Mean Arterial Pressure (MAP)
Intraoperative mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg)
Time frame: Intraoperative mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg)
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