Nasal SurgeryNCT07660562
Remifentanil vs. Nicardipine for Controlled Hypotension in Elective Nasal Surgery
A study testing Nicardipine and Remifentanil in people with Nasal Surgery and Anesthesia, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Surgery, Anesthesia, Controlled Hypotension for Nasal Surgeries
- What is being tested?
- Nicardipine and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2026to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Not pregnant or breastfeeding
- BMI ≤ 35 kg/m²
- No emergency surgical indication
- Written informed consent obtained
Who cannot join
- 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
Show all 9Show fewer
- Morbid obesity (BMI > 35 kg/m²)
- Emergency surgery
- Refusal to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Remifentanil and Nicardipine Infusions for Controlled Hypotension in Elective Nasal Surgery Where Bleeding Control is Critical: A Randomized Controlled 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.
Read the 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.
- Being tested
- Nicardipine, Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicardipineDrug
Nicardipine infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery. Standard institutional protocol applied.
RemifentanilDrug
Remifentanil infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery. Standard institutional protocol applied.
| Study group | Role | What they receive |
|---|---|---|
| Nicardipine Group | Experimental | Nicardipine infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery. Standard institutional protocol applied. Receives: Drug: Nicardipine |
| Remifentanil Group | Active comparator | Remifentanil infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery. Standard institutional protocol applied. Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Intraoperative period, approximately up to 3 hours
Secondary outcomes (6)
Extubation Time
Time from discontinuation of anesthetic agents to successful extubation (minutes)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Post-extubation through PACU discharge, up to 2 hours
Heart Rate
Intraoperative heart rate monitored via standard ECG (beats per minute)
Measured: Intraoperative period, approximately up to 2 hours
Mean Arterial Pressure (MAP)
Intraoperative mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg)
Measured: Intraoperative mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start25 Jun 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fikret Salık, Dicle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660562
- Sponsor's protocol ID
- 83/2026
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Remifentanil and Nicardipine Infusions for Controlled Hypotension in Elective Nasal Surgery Where Bleeding Control is Critical: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07660562
- Acronym / sponsor ID
- 83/2026
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 25 Jun 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicardipine Group | Experimental | Drug: NicardipineNicardipine infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery. Standard institutional protocol applied. |
| Remifentanil Group | Active comparator | Drug: RemifentanilRemifentanil infusion administered to achieve controlled hypotension (target MAP 55-65 mmHg) under general anesthesia prior to elective nasal surgery. Standard institutional protocol applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicardipineNicardipine 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 Group |
| RemifentanilRemifentanil 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 Group |
Primary outcome
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)
6 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Nicardipine and Remifentanil in people with Nasal Surgery and Anesthesia, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fikret Salık (+905076214125, fikretsalik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Field Quality (time frame: Intraoperative period, approximately up to 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.