An interventional study of Nicardipine and Remifentanil in Nasal Surgery, Anesthesia and Controlled Hypotension for Nasal Surgeries, sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Not applicable, Interventional, and Treatment
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.
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.
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital is the lead sponsor of 56 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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
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 infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery. Standard institutional protocol applied.
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)
Time frame: Intraoperative period, approximately up to 3 hours
Extubation Time
Time from discontinuation of anesthetic agents to successful extubation (minutes)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Post-extubation through PACU discharge, up to 2 hours
Heart Rate
Intraoperative heart rate monitored via standard ECG (beats per minute)
Time frame: Intraoperative period, approximately up to 2 hours
Mean Arterial Pressure (MAP)
Intraoperative mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg)
Time frame: Intraoperative mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg)
No study locations are listed for this record.
Plan to share: Yes
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital