Remifentanil Monotherapy vs. Remifentanil-Nicardipine for Controlled Hypotension in Otolaryngological Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDicle University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged > 18 years

American Society of Anesthesiologists (ASA) physical status I-II

Scheduled to undergo otolaryngological surgery under general anesthesia

Provision of written informed consent

Disqualifiers

Aged < 18 years

ASA physical status III or higher

Known severe cardiovascular (coronary artery disease, heart failure, uncontrolled hypertension), respiratory, renal, or hepatic disease

Known allergy to the study drugs (remifentanil, nicardipine)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remifentanil / Nicardipine

    Drug

    Co-administration of intravenous remifentanil and nicardipine infusions as part of a standardized protocol to induce and maintain controlled hypotension

  • Remifentanil

    Drug

    Standard intravenous infusion of remifentanil to maintain controlled hypotension according to the routine anesthesia protocol.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Patients received RemifentanilActive comparator 1 intervention
Group B: Patients received Remifentanil-NikardipinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

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