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The Effects of Nicardipine and Esmolol Applied for Controlled Hypotension

The Effects of Nicardipine and Esmolol Applied for Controlled Hypotension in Rhinoplasty Procedures on Hemodynamics and Regional Renal Oxygenation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05430724
Enrollment
80
Registered
2022-06-24
Start date
2022-05-12
Completion date
2022-08-30
Last updated
2022-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension, Oxygen Deficiency, Surgery-Complications

Keywords

Controlled hypotension, rhinoplasty, esmolol, nicardipine, regional renal oxygenation

Brief 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.

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. 2\) 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. 3\) 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. 4\) 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.

Interventions

PROCEDUREControlled hypotention

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. 2\) General anesthesia will be applied to all groups. Patients will be administered controlled hypotension (mean arterial pressure 50-60 mmHg).

Sponsors

Yuzuncu Yil University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention 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).

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* ASA III-IV patients, * hypertension disease, * using anticoagulant medication, * pregnancy, * kidney failure, * bleeding diathesis, * active infection, * allergy to drugs to be used, * BMI≥30, * refusing to participate in the study, * hypothermic, * patients taking antibiotics, anticonvulsants, antiarrhythmics, cholinesterase inhibitors

Design outcomes

Primary

MeasureTime frameDescription
Level of hypotension1 yearMeasuring mean blood pressures
Monitoring of renal oxygen saturation1 yearMeasurement of regional renal oxygenation

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 26, 2026