HypotensionNCT05430724
The Effects of Nicardipine and Esmolol Applied for Controlled Hypotension
A study of Hypotension and Surgery-Complications, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effects of nicardipine and esmolol applied for controlled hypotension in rhinoplasty on hemodynamics and regional renal oxygenation will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypotension, Surgery-Complications, Oxygen Deficiency
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2022to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 18-60 years of age,
- ASA I-II,
- undergoing elective rhinoplasty surgery,
- it was decided to apply controlled hypotension,
- BMI (body mass index) between 18-25 kg/m2,
- informed about the subject and
- patients with written consent
Who cannot join
- ASA III-IV patients,
- hypertension disease,
- using anticoagulant medication,
- pregnancy,
- kidney failure,
- bleeding diathesis,
Show all 12Show fewer
- active infection,
- allergy to drugs to be used,
- BMI≥30,
- refusing to participate in the study,
- hypothermic,
- patients taking antibiotics, anticonvulsants, antiarrhythmics, cholinesterase inhibitors
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van yuzuncu Yıl University, Dursun Odabas Medical Center
Van, 65080
About this study
Official title: The Effects of Nicardipine and Esmolol Applied for Controlled Hypotension in Rhinoplasty Procedures on Hemodynamics and Regional Renal Oxygenation
In this study, the effects of nicardipine and esmolol applied for controlled hypotension in rhinoplasty on hemodynamics and regional renal oxygenation will be investigated.
Read the detailed description
The procedure to be applied to the cases to be included in the study:
Patients randomized by the sealed envelope method will be divided into 2 groups (40 patients in each group).
The sealed envelopes that determine which group the patient will belong to will be randomly selected by the patient.
Standard general anesthesia will be applied to all patients. Before starting the surgical procedure; Group N (Nicardipine infusion) will be administered at a dose of 5-15mg/h, and Group E (Esmolol infusion) at a dose of 50-300mcg/kg/min.
- General anesthesia will be applied to all groups. Patients will be administered controlled hypotension (mean arterial pressure 50-60 mmHg).
After the patients are taken to the operating table, standard electrocardiography (ECG), peripheral oxygen saturation (SpO2), heart rate (HR), blood pressure monitoring, and regional renal oxygenation will be provided with Near-infrared reflectance spectroscopy (NIRS) monitoring. .
Systolic arterial pressure (SAB), diastolic arterial pressure (DAP), mean arterial pressure (MAP), HR, SpO2, and NIRS values will be recorded.
- Demographic data of the patients [age, weight, height, body mass index (BMI), smoking], duration of operation, need for intraoperative muscle relaxants and/or opioids, surgical satisfaction and intraoperative blood loss will be recorded.
- General anesthesia procedure: After monitoring as standard, vascular access will be opened with 2 pieces of 18 gauge cannula. After adequate preoxygenation, induction will be achieved with 2mg/kg propofol, 2/µg fentanyl and 0.6mg rocuronium. In the maintenance of anesthesia, 40% O2, 60% medical air and 1 MAC value Desflurane inhaler will be used as anesthetic agent. Anesthesia puberty will be followed by BIS monitoring and BIS value will be kept between 40-60 in all patients.
For regional renal oxygenation, NIRS probes will be placed in both kidneys (at the level of the posterior axillary line, between the lumbar 6-7 range. After the initial value is recorded, recordings will be taken every 5 minutes throughout the operation. A 20% change in values will be considered significant.
At the end of the operation, after standard decurarization, extubation will be performed when appropriate conditions are met. After the recovery, the Mini Mental Test will be filled in the patient.
A surgical satisfaction questionnaire will be filled after the operation.
- Conditions
- Hypotension, Surgery-Complications, Oxygen Deficiency
- Being tested
- Controlled hypotention
- Keywords
- Controlled hypotension, rhinoplasty, esmolol, nicardipine, regional renal oxygenation
- Medical subject headings
- Hypotension, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled hypotentionProcedure or surgery
The procedure to be applied to the cases to be included in the study:
Patients randomized by the sealed envelope method will be divided into 2 groups (40 patients in each group).
The sealed envelopes that determine which group the patient will belong to will be randomly selected by the patient.
Standard general anesthesia will be applied to all patients. Before starting the surgical procedure; Group N (Nicardipine infusion) will be administered at a dose of 5-15mg/h, and Group E (Esmolol infusion) at a dose of 50-300mcg/kg/min.
- General anesthesia will be applied to all groups. Patients will be administered controlled hypotension (mean arterial pressure 50-60 mmHg).
| Study group | Role | What they receive |
|---|---|---|
| Grup E | Active comparator | Patients given esmolol infusion Receives: Procedure: Controlled hypotention |
| Grup N | Active comparator | Patients given nicardipine infusion Receives: Procedure: Controlled hypotention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of hypotension
Measuring mean blood pressures
Measured: 1 year
Monitoring of renal oxygen saturation
Measurement of regional renal oxygenation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start12 May 2022
- Primary completion1 Aug 2022
- Study completion30 Aug 2022
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 HypotensionStudies 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
- Model description
- The patients included in the study will be divided into 2 groups according to the closed envelope system. Patients given esmolol infusion will be named Group E (n:40), patients given nicardipine infusion will be named Group N (n:40).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nureddin YUZKAT, Yuzuncu Yil University
- Investigators
- Nureddin Yuzkat, Principal investigator, Van Yuzuncu Yil University, Faculty of Medicine, Tusba, Van, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430724
- Sponsor's protocol ID
- Controlled hypotension esmolol
- Status last verified
- Sep 2022
- First submitted
- 12 May 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and statistical analysis plan wil be share other researchers
Publications
Lin S, McKenna SJ, Yao CF, Chen YR, Chen C. Effects of Hypotensive Anesthesia on Reducing Intraoperative Blood Loss, Duration of Operation, and Quality of Surgical Field During Orthognathic Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Oral Maxillofac Surg. 2017 Jan;75(1):73-86. doi: 10.1016/j.joms.2016.07.012. Epub 2016 Jul 25.
PubMed 27542543Pilli G, Guzeldemir ME, Bayhan N. Esmolol for hypotensive anesthesia in middle ear surgery. Acta Anaesthesiol Belg. 1996;47(2):85-91.
PubMed 8869676Steppan J, Hogue CW Jr. Cerebral and tissue oximetry. Best Pract Res Clin Anaesthesiol. 2014 Dec;28(4):429-39. doi: 10.1016/j.bpa.2014.09.002. Epub 2014 Sep 28.
PubMed 25480772Cintan K, Yuzkat N, Demir CY, Tuncdemir YE. Effects of nicardipine and esmolol on regional renal oxygenation and hemodynamics during controlled hypotension in rhinoplasty: A prospective, randomized clinical trial. Medicine (Baltimore). 2026 Jul 24;105(30):e49888. doi: 10.1097/MD.0000000000049888.
PubMed 42499028
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Nicardipine and Esmolol Applied for Controlled Hypotension in Rhinoplasty Procedures on Hemodynamics and Regional Renal Oxygenation
- ClinicalTrials.gov ID
- NCT05430724
- Acronym / sponsor ID
- Controlled hypotension esmolol
- Conditions
- Hypotension, Surgery-Complications, Oxygen Deficiency
- Keywords
- Controlled hypotension, rhinoplasty, esmolol, nicardipine, regional renal oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 24 Jun 2022 (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.
In this study, the effects of nicardipine and esmolol applied for controlled hypotension in rhinoplasty on hemodynamics and regional renal oxygenation will be investigated.
Detailed description
The procedure to be applied to the cases to be included in the study:
Patients randomized by the sealed envelope method will be divided into 2 groups (40 patients in each group).
The sealed envelopes that determine which group the patient will belong to will be randomly selected by the patient.
Standard general anesthesia will be applied to all patients. Before starting the surgical procedure; Group N (Nicardipine infusion) will be administered at a dose of 5-15mg/h, and Group E (Esmolol infusion) at a dose of 50-300mcg/kg/min.
- General anesthesia will be applied to all groups. Patients will be administered controlled hypotension (mean arterial pressure 50-60 mmHg).
After the patients are taken to the operating table, standard electrocardiography (ECG), peripheral oxygen saturation (SpO2), heart rate (HR), blood pressure monitoring, and regional renal oxygenation will be provided with Near-infrared reflectance spectroscopy (NIRS) monitoring. .
Systolic arterial pressure (SAB), diastolic arterial pressure (DAP), mean arterial pressure (MAP), HR, SpO2, and NIRS values will be recorded.
- Demographic data of the patients [age, weight, height, body mass index (BMI), smoking], duration of operation, need for intraoperative muscle relaxants and/or opioids, surgical satisfaction and intraoperative blood loss will be recorded.
- General anesthesia procedure: After monitoring as standard, vascular access will be opened with 2 pieces of 18 gauge cannula. After adequate preoxygenation, induction will be achieved with 2mg/kg propofol, 2/µg fentanyl and 0.6mg rocuronium. In the maintenance of anesthesia, 40% O2, 60% medical air and 1 MAC value Desflurane inhaler will be used as anesthetic agent. Anesthesia puberty will be followed by BIS monitoring and BIS value will be kept between 40-60 in all patients.
For regional renal oxygenation, NIRS probes will be placed in both kidneys (at the level of the posterior axillary line, between the lumbar 6-7 range. After the initial value is recorded, recordings will be taken every 5 minutes throughout the operation. A 20% change in values will be considered significant.
At the end of the operation, after standard decurarization, extubation will be performed when appropriate conditions are met. After the recovery, the Mini Mental Test will be filled in the patient.
A surgical satisfaction questionnaire will be filled after the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The patients included in the study will be divided into 2 groups according to the closed envelope system. Patients given esmolol infusion will be named Group E (n:40), patients given nicardipine infusion will be named Group N (n:40).
| Arm | Type | Receives |
|---|---|---|
| Grup E | Active comparator | Procedure: Controlled hypotentionPatients given esmolol infusion |
| Grup N | Active comparator | Procedure: Controlled hypotentionPatients given nicardipine infusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Between 18-60 years of age,
- ASA I-II,
- undergoing elective rhinoplasty surgery,
- it was decided to apply controlled hypotension,
- BMI (body mass index) between 18-25 kg/m2,
Key exclusion criteria (12 listed)
- ASA III-IV patients,
- hypertension disease,
- using anticoagulant medication,
- pregnancy,
- kidney failure,
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 |
|---|---|---|
| Controlled hypotentionThe procedure to be applied to the cases to be included in the study: Patients randomized by the sealed envelope method will be divided into 2 groups (40 patients in each group). The sealed envelopes that determine which group the patient will belong to will be randomly selected by the patient. Standard general anesthesia will be applied to all patients. Before starting the surgical procedure; Group N (Nicardipine infusion) will be administered at a dose of 5-15mg/h, and Group E (Esmolol infusion) at a dose of 50-300mcg/kg/min. 2) General anesthesia will be applied to all groups. Patients will be administered controlled hypotension (mean arterial pressure 50-60 mmHg). | Procedure or surgery | Grup E, Grup N |
Primary outcome
Level of hypotension
Time frame: 1 year
Measuring mean blood pressures
Monitoring of renal oxygen saturation
Time frame: 1 year
Measurement of regional renal oxygenation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Background: PubMed 27542543Lin S, McKenna SJ, Yao CF, Chen YR, Chen C. Effects of Hypotensive Anesthesia on Reducing Intraoperative Blood Loss, Duration of Operation, and Quality of Surgical Field During Orthognathic Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Oral Maxillofac Surg. 2017 Jan;75(1):73-86. doi: 10.1016/j.joms.2016.07.012. Epub 2016 Jul 25.
- Results publication: PubMed 8869676Pilli G, Guzeldemir ME, Bayhan N. Esmolol for hypotensive anesthesia in middle ear surgery. Acta Anaesthesiol Belg. 1996;47(2):85-91.
- Results publication: PubMed 25480772Steppan J, Hogue CW Jr. Cerebral and tissue oximetry. Best Pract Res Clin Anaesthesiol. 2014 Dec;28(4):429-39. doi: 10.1016/j.bpa.2014.09.002. Epub 2014 Sep 28.
- Derived from this study: PubMed 42499028Cintan K, Yuzkat N, Demir CY, Tuncdemir YE. Effects of nicardipine and esmolol on regional renal oxygenation and hemodynamics during controlled hypotension in rhinoplasty: A prospective, randomized clinical trial. Medicine (Baltimore). 2026 Jul 24;105(30):e49888. doi: 10.1097/MD.0000000000049888.
- Individual participant dataSharing planned: Yes. Study protocol and statistical analysis plan wil be share other researchers
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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. This study is not recruiting at the moment.
Nureddin Yuzkat principal investigator
Van Yuzuncu Yil University, Faculty of Medicine, Tusba, Van, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hypotension and Surgery-Complications, run by Yuzuncu Yil 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 7 inclusion and 12 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: finished, as of the sponsor's last update on 27 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of hypotension (time frame: 1 year). The study lists 2 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 NCT05430724, 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 27 Sep 2022.