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Remifentanil vs. Nicardipine for Controlled Hypotension in Elective Nasal Surgery

ConditionsNasal SurgeryAnesthesiaControlled Hypotension for Nasal Surgeries
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSaglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

ASA physical status I-II

Scheduled for elective nasal surgery

No known serious cardiovascular, respiratory, renal, or hepatic disease

Disqualifiers

Age < 18 years

ASA III or above

Known serious cardiovascular, respiratory, renal, or hepatic disease

Known allergy to remifentanil or nicardipine

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Nicardipine GroupExperimental treatment 1 intervention
Group B: Remifentanil GroupActive comparator 1 intervention

Trial outcomes

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)

Time frame
Intraoperative period, approximately up to 3 hours

Secondary outcomes

1

Extubation Time

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

Time frame
End of surgery through extubation, approximately up to 30 minutes
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Lead sponsor

Dicle University

Sponsor institution

Source ClinicalTrials.gov

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