Dicle University
Diyarbakır, Eyalet/Yerleşke, 21070, Turkey (Türkiye)
NCT Number: NCT07659496
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Diyarbakır, Eyalet/Yerleşke, 21070, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Co-administration of intravenous remifentanil and nicardipine infusions as part of a standardized protocol to induce and maintain controlled hypotension
Standard intravenous infusion of remifentanil to maintain controlled hypotension according to the routine anesthesia protocol.
Time frame: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation
Cardiac Index measured via MOSTCARE hemodynamic monitor through radial arterial line (L/min/m²)
Time frame: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation
Stroke Volume Index(SVI) measured via MOSTCARE hemodynamic monitor through radial arterial line (%)
Time frame: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation
assessed via MOSTCARE hemodynamic monitor through radial arterial line
Time frame: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation
assessed via MOSTCARE hemodynamic monitor through radial arterial line
Time frame: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation
Mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg)
Time frame: Intraoperative period, approximately up to 2 hours
Intraoperative surgical field visibility assessed by the surgeon using the Fromme-Boezaart scoring system (scale 0-5; higher scores indicate worse surgical field)
Time frame: Intraoperative and postoperative period, up to 24 hours
Incidence of bradycardia, hypotension, hypertension, nausea, vomiting, and other adverse events recorded by an independent blinded assessor
Contact information is provided by the study sponsor or research team.
Dicle University
Other
The Effects of Remifentanil Monotherapy Versus Remifentanil-Nicardipine Combination on Advanced Hemodynamic Parameters for Controlled Hypotension During Otolaryngological Surgery
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02376179
Otolaryngological Surgery
Columbus, Ohio, United States
View Trial DetailsNCT07718152
Anesthesia, Intraoperative Neurophysiological Monitoring
View Trial DetailsNCT07712783
Anesthesia, Neurologic Manifestations
Samsun, Turkey (Türkiye)
View Trial DetailsNCT07696221
Anesthesia, Brain Diseases
View Trial Details