Remifentanil vs. Nicardipine for Controlled Hypotension in Elective Nasal Surgery

NCT07660562 | Not Yet Recruiting

• 1 other identifier: 83/2026
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Nasal Surgery; Anesthesia; Controlled Hypotension for Nasal Surgeries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Extubation Time

  End of surgery through extubation, approximately up to 30 minutes

• Time Spent Within Target MAP Range

  Intraoperative period, approximately up to 2 hours

• Aldrete Recovery Score

  At 15 and 30 minutes post-extubation, up to 2 hours

• Time to PACU Discharge

  Post-extubation through PACU discharge, up to 2 hours

• Heart Rate

  Intraoperative period, approximately up to 2 hours

Study Arms (2)

Nicardipine Group

EXPERIMENTAL

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

Remifentanil Group

ACTIVE COMPARATOR

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

Interventions

Nicardipine DRUG

Nicardipine infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery. Standard institutional protocol applied.

Nicardipine Group

Remifentanil DRUG

Remifentanil infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery. Standard institutional protocol applied.

Remifentanil Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Interventions

Nicardipine; Remifentanil

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Fikret Salık

CONTACT

+905076214125; fikretsalik@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• 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 25, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 15, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share