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Not yet recruiting NCT07660562

Remifentanil vs. Nicardipine for Controlled Hypotension in Elective Nasal Surgery

No phase Interventional Nasal Surgery Anesthesia Controlled Hypotension for Nasal Surgeries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nicardipine, Remifentanil.
Who it may be relevant to
Registry conditions: Nasal Surgery, Anesthesia, Controlled Hypotension for Nasal Surgeries. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Surgical Field Quality [Time frame: Intraoperative period, approximately up to 3 hours]
Secondary outcome measures (6)
  • Extubation Time [Time frame: End of surgery through extubation, approximately up to 30 minutes]
  • Time Spent Within Target MAP Range [Time frame: Intraoperative period, approximately up to 2 hours]
  • Aldrete Recovery Score [Time frame: At 15 and 30 minutes post-extubation, up to 2 hours]
  • Time to PACU Discharge [Time frame: Post-extubation through PACU discharge, up to 2 hours]
  • Heart Rate [Time frame: Intraoperative period, approximately up to 2 hours]
  • Mean Arterial Pressure (MAP) [Time frame: Intraoperative mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07660562 · 83/2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗