Remifentanil vs. Nicardipine for Controlled Hypotension in Elective Nasal Surgery

Comparison of Remifentanil and Nicardipine Infusions for Controlled Hypotension in Elective Nasal Surgery Where Bleeding Control is Critical: A Randomized Controlled Trial

This study compares remifentanil infusion versus nicardipine infusion for controlled hypotension during elective nasal surgery. Both agents are standard clinical methods. The study evaluates hemodynamic stability, surgical field quality (Fromme-Boezaart score), tissue perfusion, intraoperative blood loss, surgeon satisfaction, and perioperative adverse effects.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia; Nasal Surgery; Controlled Hypotension for Nasal Surgeries
• Intervention / Treatment: Drug: Nicardipine; Drug: Remifentanil

Detailed Description

This is a prospective, randomized, controlled, parallel-group, single-blind (outcomes assessor-blinded) clinical study. Forty-four patients (ASA I-II, age >18) undergoing elective nasal surgery will be randomized 1:1 using a computer-based random number generator with sealed envelope allocation. The intervention group will receive nicardipine infusion; the control group will receive remifentanil infusion. Both are standard controlled hypotension methods used routinely at our institution. Hemodynamic parameters will be recorded at seven predefined time points. All perioperative measurements will be recorded by an independent blinded assessor. Statistical analysis: SPSS v24.0, p ≤ 0.05.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fikret Salık; Phone Number: +905076214125; Email: fikretsalik@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age > 18 years
• ASA physical status I-II
• Scheduled for elective nasal surgery
• No known serious cardiovascular, respiratory, renal, or hepatic disease
• No known allergy to remifentanil or nicardipine
• No chronic use of beta-blockers, calcium channel blockers, or antihypertensive agents
• Not pregnant or breastfeeding
• BMI ≤ 35 kg/m²
• No emergency surgical indication
• Written informed consent obtained

Exclusion Criteria:

• Age < 18 years
• ASA III or above
• Known serious cardiovascular, respiratory, renal, or hepatic disease
• Known allergy to remifentanil or nicardipine
• Chronic use of beta-blockers, calcium channel blockers, or antihypertensive agents
• Pregnancy or breastfeeding
• Morbid obesity (BMI > 35 kg/m²)
• Emergency surgery
• Refusal to participate

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
Experimental: Nicardipine Group; Nicardipine infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery. Standard institutional protocol applied.	Drug: Nicardipine; Nicardipine infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery. Standard institutional protocol applied.
Active Comparator: Remifentanil Group; Remifentanil infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery. Standard institutional protocol applied.	Drug: Remifentanil; Remifentanil infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery. Standard institutional protocol applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Field Quality	Intraoperative surgical field visibility assessed by the surgeon using the Fromme-Boezaart Bleeding Scale (scale 0-5; 0 = no bleeding, cadaveric field; 5 = severe bleeding, surgery not possible; lower scores indicate better surgical field)	Intraoperative period, approximately up to 3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extubation Time	Time from discontinuation of anesthetic agents to successful extubation (minutes)	End of surgery through extubation, approximately up to 30 minutes
Time Spent Within Target MAP Range	Duration of intraoperative period during which mean arterial pressure remained within the target range of 55-65 mmHg (minutes)	Intraoperative period, approximately up to 2 hours
Aldrete Recovery Score	Postoperative recovery assessed using the Aldrete Score (scale 0-10; higher scores indicate better recovery; score ≥ 9 required for PACU discharge)	At 15 and 30 minutes post-extubation, up to 2 hours
Time to PACU Discharge	Time from arrival to PACU to meeting discharge criteria (minutes)	Post-extubation through PACU discharge, up to 2 hours
Heart Rate	Intraoperative heart rate monitored via standard ECG (beats per minute)	Intraoperative period, approximately up to 2 hours
Mean Arterial Pressure (MAP)	Intraoperative mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg)	Intraoperative mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg)

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 25, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 15, 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: 83/2026

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