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

Official title

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

Overview

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.

Interventions

• Drug Remifentanil / Nicardipine
  Co-administration of intravenous remifentanil and nicardipine infusions as part of a standardized protocol to induce and maintain controlled hypotension
• Drug Remifentanil
  Standard intravenous infusion of remifentanil to maintain controlled hypotension according to the routine anesthesia protocol.

Primary outcome measures

• Cardiac Index (CI) [Time frame: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation]
• Stroke Volume Index(SVI) [Time frame: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation]
• Systemic Vascular Resistance Index (SVRI) [Time frame: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation]
• Cardiac Power Index (CPI) [Time frame: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation]

Secondary outcome measures (3)

• Heart Rate [Time frame: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation]
• Surgical Field Quality [Time frame: Intraoperative period, approximately up to 2 hours]
• Incidence of Perioperative Adverse Events [Time frame: Intraoperative and postoperative period, up to 24 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Dicle University — Diyarbakır

Publications

• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07659496 · 82/2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗