Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Controlled hypotension is a widely employed technique in otolaryngological (ear, nose, and throat) surgery, primarily aimed at improving surgical field visibility and minimizing intraoperative blood loss. By maintaining mean arterial pressure within a targeted range, this approach facilitates a clearer operative field, reduces the need for blood transfusion, and shortens operative time, thereby contributing to improved surgical outcomes.
Among the pharmacological agents used to achieve controlled hypotension, remifentanil - an ultra-short-acting synthetic opioid - has gained widespread acceptance due to its rapid onset, predictable offset, and favorable hemodynamic profile. Nicardipine, a second-generation dihydropyridine calcium channel blocker, is also utilized for its potent vasodilatory properties and titratable antihypertensive effect. When used in combination, these two agents may offer complementary mechanisms of action; however, their combined impact on advanced hemodynamic parameters remains insufficiently characterized in the otolaryngological surgical setting.
The primary aim of this study is to compare the effects of remifentanil monotherapy versus remifentanil-nicardipine combination therapy on advanced hemodynamic parameters, cardiac physiology, and tissue perfusion in patients undergoing controlled hypotension during otolaryngological surgery. Advanced hemodynamic monitoring - including parameters such as cardiac output, stroke volume, systemic vascular resistance, and oxygen delivery indices - will provide a more comprehensive physiological assessment beyond conventional blood pressure measurements.
As secondary objectives, this study will evaluate and compare both regimens with respect to surgical field quality, surgeon satisfaction, intraoperative hemodynamic stability, and perioperative adverse effects. It is anticipated that a thorough comparative analysis of these two approaches will contribute to evidence-based anesthetic decision-making and help optimize patient safety and surgical outcomes in otolaryngological procedures.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients received Remifentanil | Active Comparator |
| |
| Patients received Remifentanil-Nikardipin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil / Nicardipine | Drug | Co-administration of intravenous remifentanil and nicardipine infusions as part of a standardized protocol to induce and maintain controlled hypotension |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Index (CI) | Cardiac Index measured via MOSTCARE hemodynamic monitor through radial arterial line (L/min/m²) | Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation |
| Stroke Volume Index(SVI) | Stroke Volume Index(SVI) measured via MOSTCARE hemodynamic monitor through radial arterial line (%) | Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation |
| Systemic Vascular Resistance Index (SVRI) | assessed via MOSTCARE hemodynamic monitor through radial arterial line | Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation |
| Cardiac Power Index (CPI) | assessed via MOSTCARE hemodynamic monitor through radial arterial line | Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg) | Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation |
| Surgical Field Quality |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ayhan Kaydu | Contact | +90 505 556 7939 | akaydu@hotmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dicle University | Diyarbakır | Eyalet/Yerleşke | 21070 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2495074 | Background | Yunus MB. Fibromyalgia syndrome: new research on an old malady. BMJ. 1989 Feb 25;298(6672):474-5. doi: 10.1136/bmj.298.6672.474. No abstract available. | |
| 28639533 | Background | Kim JY, Song SH, Cho JH, Cho HR. Comparison of clinical efficacy among remifentanil, nicardipine, and remifentanil plus nicardipine continuous infusion for hypotensive anesthesia during arthroscopic shoulder surgery. J Orthop Surg (Hong Kong). 2017 May-Aug;25(2):2309499017716251. doi: 10.1177/2309499017716251. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D009529 | Nicardipine |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Remifentanil | Drug | Standard intravenous infusion of remifentanil to maintain controlled hypotension according to the routine anesthesia protocol. |
|
Intraoperative surgical field visibility assessed by the surgeon using the Fromme-Boezaart scoring system (scale 0-5; higher scores indicate worse surgical field)
| Intraoperative period, approximately up to 2 hours |
| Incidence of Perioperative Adverse Events | Incidence of bradycardia, hypotension, hypertension, nausea, vomiting, and other adverse events recorded by an independent blinded assessor | Intraoperative and postoperative period, up to 24 hours |
| 11212044 | Background | 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. doi: 10.1007/BF03019809. |
| 21906322 | Background | Marik PE, Monnet X, Teboul JL. Hemodynamic parameters to guide fluid therapy. Ann Intensive Care. 2011 Mar 21;1(1):1. doi: 10.1186/2110-5820-1-1. |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |