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NCT Number: NCT07660562

Remifentanil vs. Nicardipine for Controlled Hypotension in Elective Nasal Surgery

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.

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Key information

Conditions

Nasal Surgery Anesthesia Controlled Hypotension for Nasal Surgeries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Surgical Field Quality

    Time frame: Intraoperative period, approximately up to 3 hours

    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)

Secondary outcomes

  1. Extubation Time

    Time frame: End of surgery through extubation, approximately up to 30 minutes

    Time from discontinuation of anesthetic agents to successful extubation (minutes)

  2. Time Spent Within Target MAP Range

    Time frame: Intraoperative period, approximately up to 2 hours

    Duration of intraoperative period during which mean arterial pressure remained within the target range of 55-65 mmHg (minutes)

  3. Aldrete Recovery Score

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

    Postoperative recovery assessed using the Aldrete Score (scale 0-10; higher scores indicate better recovery; score ≥ 9 required for PACU discharge)

  4. Time to PACU Discharge

    Time frame: Post-extubation through PACU discharge, up to 2 hours

    Time from arrival to PACU to meeting discharge criteria (minutes)

  5. Heart Rate

    Time frame: Intraoperative period, approximately up to 2 hours

    Intraoperative heart rate monitored via standard ECG (beats per minute)

  6. Mean Arterial Pressure (MAP)

    Time frame: Intraoperative mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg)

    Intraoperative mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg)

Study contacts

Contact information is provided by the study sponsor or research team.

Fikret Salık

CONTACT

[email protected]

+905076214125

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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