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

In this study, the effects of nicardipine and esmolol applied for controlled hypotension in rhinoplasty on hemodynamics and regional renal oxygenation will be investigated.

Study Overview

• Status: Completed
• Conditions: Hypotension; Oxygen Deficiency; Surgery-Complications
• Intervention / Treatment: Procedure: Controlled hypotention

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Van, Turkey, 65080
    • Van Yüzüncü Yıl University, Dursun Odabaş Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Grup E; Patients given esmolol infusion	Procedure: Controlled 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).
Active Comparator: Grup N; Patients given nicardipine infusion	Procedure: Controlled 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of hypotension	Measuring mean blood pressures	1 year
Monitoring of renal oxygen saturation	Measurement of regional renal oxygenation	1 year

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University
• Investigators: Principal Investigator: Nureddin Yuzkat, Van Yuzuncu Yil University, Faculty of Medicine, Tusba, Van, Turkey

Publications and helpful links

General 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.
• Pilli G, Guzeldemir ME, Bayhan N. Esmolol for hypotensive anesthesia in middle ear surgery. Acta Anaesthesiol Belg. 1996;47(2):85-91.
• Steppan 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: June 18, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: rhinoplasty; nicardipine; esmolol; Controlled hypotension; regional renal oxygenation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Signs and Symptoms, Respiratory; Hypotension; Hypoxia
• Other Study ID Numbers: Controlled hypotension esmolol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol and statistical analysis plan wil be share other researchers
• IPD Sharing Time Frame: One year
• IPD Sharing Access Criteria: the access can be provided via the e-mail addresses below nyuzkat@gmail.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No