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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicardipine Group | Experimental | 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 Group | Active Comparator | Remifentanil infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery. Standard institutional protocol applied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicardipine | Drug | Nicardipine infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery. Standard institutional protocol applied. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Intraoperative period, approximately up to 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Extubation Time | Time from discontinuation of anesthetic agents to successful extubation (minutes) | End of surgery through extubation, approximately up to 30 minutes |
| Time Spent Within Target MAP Range |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fikret Salık | Contact | +905076214125 | fikretsalik@gmail.com |
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| ID | Term |
|---|---|
| D009529 | Nicardipine |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Remifentanil | Drug | Remifentanil infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery. Standard institutional protocol applied. |
|
Duration of intraoperative period during which mean arterial pressure remained within the target range of 55-65 mmHg (minutes)
| 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) | 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) | Post-extubation through PACU discharge, up to 2 hours |
| Heart Rate | Intraoperative heart rate monitored via standard ECG (beats per minute) | Intraoperative period, approximately up to 2 hours |
| Mean Arterial Pressure (MAP) | Intraoperative mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg) | Intraoperative mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg) |
| D011422 |
| Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |