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

NCT07659496 | Not Yet Recruiting

• 1 other identifier: 82/2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Otolaryngological Surgery; Anesthesia

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Heart Rate

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

• Surgical Field Quality

  Intraoperative period, approximately up to 2 hours

• Incidence of Perioperative Adverse Events

  Intraoperative and postoperative period, up to 24 hours

Study Arms (2)

Patients received Remifentanil

ACTIVE COMPARATOR

Drug: Remifentanil

Patients received Remifentanil-Nikardipin

EXPERIMENTAL

Drug: Remifentanil / Nicardipine

Interventions

Remifentanil / Nicardipine DRUG

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

Patients received Remifentanil-Nikardipin

Remifentanil DRUG

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

Patients received Remifentanil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dicle University: lead

Study Sites (1)

Dicle University

Diyarbakır, Eyalet/Yerleşke, 21070, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 2495074 BACKGROUND

• 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.

  PMID: 28639533 BACKGROUND

• 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.

  PMID: 11212044 BACKGROUND

• 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.

  PMID: 21906322 BACKGROUND

MeSH Terms

Interventions

Remifentanil; Nicardipine

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines

Central Study Contacts

Ayhan Kaydu

CONTACT

+90 505 556 7939; akaydu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medicine Doctor Associate Professor in Anesthesiology

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 22, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)