The Effects of Nicardipine and Esmolol Applied for Controlled Hypotension

Not Applicable

Completed

• Conditions: Surgery-Complications; Oxygen Deficiency; Hypotension
• Interventions: Procedure: Controlled hypotention

• Registration Number: NCT05430724
• Lead Sponsor: Yuzuncu Yıl University

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.

Study Timeline

• Study Start: 2022-05-12
• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-06-18
• Study First Posted: 2022-06-24
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-23
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Grup E	Controlled hypotention	Patients given esmolol infusion
Grup N	Controlled hypotention	Patients given nicardipine infusion

Primary Outcome Measures

Name	Time	Method
Level of hypotension	1 year	Measuring mean blood pressures
Monitoring of renal oxygen saturation	1 year	Measurement of regional renal oxygenation

Trial Locations

Locations (1)

Van yuzuncu Yıl University, Dursun Odabas Medical Center; 🇹🇷 Van, Turkey