Anesthesia, Controlled Hypotension for Nasal Surgeries, Nasal Surgery
Conditions
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.
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
DRUGNicardipine
Nicardipine infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery. Standard institutional protocol applied.
DRUGRemifentanil
Remifentanil infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery. Standard institutional protocol applied.
Sponsors
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Field Quality | 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
| Measure | Time frame | Description |
|---|---|---|
| Extubation Time | End of surgery through extubation, approximately up to 30 minutes | Time from discontinuation of anesthetic agents to successful extubation (minutes) |
| Time Spent Within Target MAP Range | 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) |
| Aldrete Recovery Score | 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) |
| Time to PACU Discharge | Post-extubation through PACU discharge, up to 2 hours | Time from arrival to PACU to meeting discharge criteria (minutes) |
| Heart Rate | Intraoperative period, approximately up to 2 hours | Intraoperative heart rate monitored via standard ECG (beats per minute) |
| Mean Arterial Pressure (MAP) | Intraoperative mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg) | Intraoperative mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg) |
Contacts
CONTACTFikret Salık
Outcome results
None listed