An interventional study of Remifentanil / Nicardipine and Remifentanil in Otolaryngological Surgery and Anesthesia, sponsored by Dicle University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Dicle University · Not applicable, Interventional, and Treatment
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.
Dicle University is the lead sponsor of 28 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Remifentanil
Drug: Remifentanil / Nicardipine
Drug pages: Remifentanil · Nicardipine
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.
Cardiac Index (CI)
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)
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
Systemic Vascular Resistance Index (SVRI)
assessed via MOSTCARE hemodynamic monitor through radial arterial line
Time frame: 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
Time frame: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation
Heart Rate
Mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg)
Time frame: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation
Surgical Field Quality
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 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
Time frame: Intraoperative and postoperative period, up to 24 hours
Plan to share: Yes
Start is estimated for Jun 2026; primary completion for Aug 2026, 1 month later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Remifentanil · Nicardipine
Dicle University