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NCT Number: NCT07659496

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • Chronic use of beta-blockers, calcium channel blockers, or any other medication affecting blood pressure
  • Pregnancy or breastfeeding
  • Morbid obesity
  • Emergency surgery requirement
  • Refusal to participate in the study

Treatment and study plan

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.

Primary outcomes

  1. Cardiac Index (CI)

    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)

  2. Stroke Volume Index(SVI)

    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 (%)

  3. Systemic Vascular Resistance Index (SVRI)

    Time frame: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation

    assessed via MOSTCARE hemodynamic monitor through radial arterial line

  4. Cardiac Power Index (CPI)

    Time frame: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation

    assessed via MOSTCARE hemodynamic monitor through radial arterial line

Secondary outcomes

  1. Heart Rate

    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)

  2. Surgical Field Quality

    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)

  3. Incidence of Perioperative Adverse Events

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Ayhan Kaydu

CONTACT

[email protected]

+90 505 556 7939

Sponsors and collaborators

Lead sponsor

Dicle University

Other

Registry information

Official study title

The Effects of Remifentanil Monotherapy Versus Remifentanil-Nicardipine Combination on Advanced Hemodynamic Parameters for Controlled Hypotension During Otolaryngological Surgery

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

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.

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