Otolaryngological SurgeryNCT07659496
Remifentanil Monotherapy vs. Remifentanil-Nicardipine for Controlled Hypotension in Otolaryngological Surgery
A study testing Remifentanil / Nicardipine and Remifentanil in people with Otolaryngological Surgery and Anesthesia, run by Dicle University at 1 site in Turkey (Türkiye).
Trial summary
Controlled hypotension is a widely employed technique in otolaryngological (ear, nose, and throat) surgery, primarily aimed at improving surgical field visibility and minimizing intraoperative blood loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Otolaryngological Surgery, Anesthesia
- What is being tested?
- Remifentanil / Nicardipine and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2026to 30 Aug 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
- Patients aged > 18 years
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled to undergo otolaryngological surgery under general anesthesia
- Provision of written informed consent
Who cannot join
- Aged < 18 years
- ASA physical status III or higher
- Known severe cardiovascular (coronary artery disease, heart failure, uncontrolled hypertension), respiratory, renal, or hepatic disease
- Known allergy to the study drugs (remifentanil, nicardipine)
- Chronic use of beta-blockers, calcium channel blockers, or any other medication affecting blood pressure
- Pregnancy or breastfeeding
Show all 9Show fewer
- Morbid obesity
- Emergency surgery requirement
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Dicle University
Diyarbakır, Eyalet/Yerleşke, 21070
Ayhan Kaydu, +90 505 556 7939, akaydu@hotmail.com
About this study
Official title: The Effects of Remifentanil Monotherapy Versus Remifentanil-Nicardipine Combination on Advanced Hemodynamic Parameters for Controlled Hypotension During Otolaryngological Surgery
Controlled hypotension is a widely employed technique in otolaryngological (ear, nose, and throat) surgery, primarily aimed at improving surgical field visibility and minimizing intraoperative blood loss. By maintaining mean arterial pressure within a targeted range, this approach facilitates a clearer operative field, reduces the need for blood transfusion, and shortens operative time, thereby contributing to improved surgical outcomes.
Among the pharmacological agents used to achieve controlled hypotension, remifentanil - an ultra-short-acting synthetic opioid - has gained widespread acceptance due to its rapid onset, predictable offset, and favorable hemodynamic profile. Nicardipine, a second-generation dihydropyridine calcium channel blocker, is also utilized for its potent vasodilatory properties and titratable antihypertensive effect. When used in combination, these two agents may offer complementary mechanisms of action; however, their combined impact on advanced hemodynamic parameters remains insufficiently characterized in the otolaryngological surgical setting.
Read more
The primary aim of this study is to compare the effects of remifentanil monotherapy versus remifentanil-nicardipine combination therapy on advanced hemodynamic parameters, cardiac physiology, and tissue perfusion in patients undergoing controlled hypotension during otolaryngological surgery. Advanced hemodynamic monitoring - including parameters such as cardiac output, stroke volume, systemic vascular resistance, and oxygen delivery indices - will provide a more comprehensive physiological assessment beyond conventional blood pressure measurements.
As secondary objectives, this study will evaluate and compare both regimens with respect to surgical field quality, surgeon satisfaction, intraoperative hemodynamic stability, and perioperative adverse effects. It is anticipated that a thorough comparative analysis of these two approaches will contribute to evidence-based anesthetic decision-making and help optimize patient safety and surgical outcomes in otolaryngological procedures.
- Conditions
- Otolaryngological Surgery, Anesthesia
- Being tested
- Remifentanil / Nicardipine, Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil / NicardipineDrug
Co-administration of intravenous remifentanil and nicardipine infusions as part of a standardized protocol to induce and maintain controlled hypotension
RemifentanilDrug
Standard intravenous infusion of remifentanil to maintain controlled hypotension according to the routine anesthesia protocol.
| Study group | Role | What they receive |
|---|---|---|
| Patients received Remifentanil | Active comparator | Not described Receives: Drug: Remifentanil |
| Patients received Remifentanil-Nikardipin | Experimental | Not described Receives: Drug: Remifentanil / Nicardipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Index (CI)
Cardiac Index measured via MOSTCARE hemodynamic monitor through radial arterial line (L/min/m²)
Measured: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation
Stroke Volume Index(SVI)
Stroke Volume Index(SVI) measured via MOSTCARE hemodynamic monitor through radial arterial line (%)
Measured: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation
Systemic Vascular Resistance Index (SVRI)
assessed via MOSTCARE hemodynamic monitor through radial arterial line
Measured: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation
Cardiac Power Index (CPI)
assessed via MOSTCARE hemodynamic monitor through radial arterial line
Measured: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation
Secondary outcomes (3)
Heart Rate
Mean arterial pressure monitored via non-invasive blood pressure measurement (mmHg)
Measured: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation
Surgical Field Quality
Intraoperative surgical field visibility assessed by the surgeon using the Fromme-Boezaart scoring system (scale 0-5; higher scores indicate worse surgical field)
Measured: Intraoperative period, approximately up to 2 hours
Incidence of Perioperative Adverse Events
Incidence of bradycardia, hypotension, hypertension, nausea, vomiting, and other adverse events recorded by an independent blinded assessor
Measured: Intraoperative and postoperative period, up to 24 hours
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 start30 Jun 2026 (estimated)
- Primary completion15 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Otolaryngological 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
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dicle University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayhan Kaydu, Dicle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659496
- Sponsor's protocol ID
- 82/2026
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Yunus MB. Fibromyalgia syndrome: new research on an old malady. BMJ. 1989 Feb 25;298(6672):474-5. doi: 10.1136/bmj.298.6672.474. No abstract available.
PubMed 2495074Kim JY, Song SH, Cho JH, Cho HR. Comparison of clinical efficacy among remifentanil, nicardipine, and remifentanil plus nicardipine continuous infusion for hypotensive anesthesia during arthroscopic shoulder surgery. J Orthop Surg (Hong Kong). 2017 May-Aug;25(2):2309499017716251. doi: 10.1177/2309499017716251.
PubMed 28639533Degoute CS, Ray MJ, Manchon M, Dubreuil C, Banssillon V. Remifentanil and controlled hypotension; comparison with nitroprusside or esmolol during tympanoplasty. Can J Anaesth. 2001 Jan;48(1):20-7. doi: 10.1007/BF03019809.
PubMed 11212044Marik PE, Monnet X, Teboul JL. Hemodynamic parameters to guide fluid therapy. Ann Intensive Care. 2011 Mar 21;1(1):1. doi: 10.1186/2110-5820-1-1.
PubMed 21906322
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
- The Effects of Remifentanil Monotherapy Versus Remifentanil-Nicardipine Combination on Advanced Hemodynamic Parameters for Controlled Hypotension During Otolaryngological Surgery
- ClinicalTrials.gov ID
- NCT07659496
- Acronym / sponsor ID
- 82/2026
- Conditions
- Otolaryngological Surgery, Anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dicle UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 30 Aug 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.
Controlled hypotension is a widely employed technique in otolaryngological (ear, nose, and throat) surgery, primarily aimed at improving surgical field visibility and minimizing intraoperative blood loss. By maintaining mean arterial pressure within a targeted range, this approach facilitates a clearer operative field, reduces the need for blood transfusion, and shortens operative time, thereby contributing to improved surgical outcomes.
Among the pharmacological agents used to achieve controlled hypotension, remifentanil - an ultra-short-acting synthetic opioid - has gained widespread acceptance due to its rapid onset, predictable offset, and favorable hemodynamic profile. Nicardipine, a second-generation dihydropyridine calcium channel blocker, is also utilized for its potent vasodilatory properties and titratable antihypertensive effect. When used in combination, these two agents may offer complementary mechanisms of action; however, their combined impact on advanced hemodynamic parameters remains insufficiently characterized in the otolaryngological surgical setting.
The primary aim of this study is to compare the effects of remifentanil monotherapy versus remifentanil-nicardipine combination therapy on advanced hemodynamic parameters, cardiac physiology, and tissue perfusion in patients undergoing controlled hypotension during otolaryngological surgery. Advanced hemodynamic monitoring - including parameters such as cardiac output, stroke volume, systemic vascular resistance, and oxygen delivery indices - will provide a more comprehensive physiological assessment beyond conventional blood pressure measurements.
As secondary objectives, this study will evaluate and compare both regimens with respect to surgical field quality, surgeon satisfaction, intraoperative hemodynamic stability, and perioperative adverse effects. It is anticipated that a thorough comparative analysis of these two approaches will contribute to evidence-based anesthetic decision-making and help optimize patient safety and surgical outcomes in otolaryngological procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients received Remifentanil | Active comparator | Drug: Remifentanil |
| Patients received Remifentanil-Nikardipin | Experimental | Drug: Remifentanil / Nicardipine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged > 18 years
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled to undergo otolaryngological surgery under general anesthesia
- Provision of written informed consent
Key exclusion criteria (9 listed)
- Aged < 18 years
- ASA physical status III or higher
- Known severe cardiovascular (coronary artery disease, heart failure, uncontrolled hypertension), respiratory, renal, or hepatic disease
- Known allergy to the study drugs (remifentanil, nicardipine)
- Chronic use of beta-blockers, calcium channel blockers, or any other medication affecting blood pressure
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 |
|---|---|---|
| Remifentanil / NicardipineCo-administration of intravenous remifentanil and nicardipine infusions as part of a standardized protocol to induce and maintain controlled hypotension | Drug | Patients received Remifentanil-Nikardipin |
| RemifentanilStandard intravenous infusion of remifentanil to maintain controlled hypotension according to the routine anesthesia protocol. | Drug | Patients received Remifentanil |
Primary outcome
Cardiac Index (CI)
Time frame: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation
Cardiac Index measured via MOSTCARE hemodynamic monitor through radial arterial line (L/min/m²)
Stroke Volume Index(SVI)
Time frame: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation
Stroke Volume Index(SVI) measured via MOSTCARE hemodynamic monitor through radial arterial line (%)
Systemic Vascular Resistance Index (SVRI)
Time frame: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation
assessed via MOSTCARE hemodynamic monitor through radial arterial line
Cardiac Power Index (CPI)
Time frame: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation
assessed via MOSTCARE hemodynamic monitor through radial arterial line
3 secondary outcomes
Heart Rate
Time frame: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation
Surgical Field Quality
Time frame: Intraoperative period, approximately up to 2 hours
Incidence of Perioperative Adverse Events
Time frame: Intraoperative and postoperative period, up to 24 hours
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.
- Background: PubMed 2495074Yunus MB. Fibromyalgia syndrome: new research on an old malady. BMJ. 1989 Feb 25;298(6672):474-5. doi: 10.1136/bmj.298.6672.474. No abstract available.
- Background: PubMed 28639533Kim JY, Song SH, Cho JH, Cho HR. Comparison of clinical efficacy among remifentanil, nicardipine, and remifentanil plus nicardipine continuous infusion for hypotensive anesthesia during arthroscopic shoulder surgery. J Orthop Surg (Hong Kong). 2017 May-Aug;25(2):2309499017716251. doi: 10.1177/2309499017716251.
- Background: PubMed 11212044Degoute CS, Ray MJ, Manchon M, Dubreuil C, Banssillon V. Remifentanil and controlled hypotension; comparison with nitroprusside or esmolol during tympanoplasty. Can J Anaesth. 2001 Jan;48(1):20-7. doi: 10.1007/BF03019809.
- Background: PubMed 21906322Marik PE, Monnet X, Teboul JL. Hemodynamic parameters to guide fluid therapy. Ann Intensive Care. 2011 Mar 21;1(1):1. doi: 10.1186/2110-5820-1-1.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil / Nicardipine and Remifentanil in people with Otolaryngological Surgery and Anesthesia, run by Dicle University at 1 site in Turkey (Türkiye).
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 4 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.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ayhan Kaydu (+90 505 556 7939, akaydu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Index (CI) (time frame: Perioperative period, approximately up to 3 hours (baseline through 5 minutes post-extubation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07659496, which also lists 4 linked publications.
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.