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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia; Otolaryngological Surgery
• Intervention / Treatment: Drug: Remifentanil; Drug: Remifentanil / Nicardipine

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayhan Kaydu; Phone Number: +90 505 556 7939; Email: akaydu@hotmail.com

Study Locations

• Turkey (Türkiye)
  • Eyalet/Yerleşke
    • Diyarbakır, Eyalet/Yerleşke, Turkey (Türkiye), 21070
      • Dicle University
      • Contact: Ayhan Kaydu; Phone Number: +90 505 556 7939; Email: akaydu@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients received Remifentanil	Drug: Remifentanil; Standard intravenous infusion of remifentanil to maintain controlled hypotension according to the routine anesthesia protocol.
Experimental: Patients received Remifentanil-Nikardipin	Drug: Remifentanil / Nicardipine; Co-administration of intravenous remifentanil and nicardipine infusions as part of a standardized protocol to induce and maintain controlled hypotension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Dicle University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acids, Acyclic; Carboxylic Acids; Piperidines; Propionates; Dihydropyridines; Remifentanil; Nicardipine
• Other Study ID Numbers: 82/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No