The Effects of Nicardipine and Esmolol Applied for Controlled Hypotension

NCT05430724 | Completed

• 1 other identifier: Controlled hypotension esmolol
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension; Surgery-Complications; Oxygen Deficiency

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Level of hypotension

  Measuring mean blood pressures

  1 year

• Monitoring of renal oxygen saturation

  Measurement of regional renal oxygenation

  1 year

Study Arms (2)

Grup E

ACTIVE COMPARATOR

Patients given esmolol infusion

Procedure: Controlled hypotention

Grup N

ACTIVE COMPARATOR

Patients given nicardipine infusion

Procedure: Controlled hypotention

Interventions

Controlled hypotention PROCEDURE

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).

Grup E; Grup N

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van yuzuncu Yıl University, Dursun Odabas Medical Center

Van, 65080, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 27542543 BACKGROUND

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

  PMID: 8869676 RESULT

• 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.

  PMID: 25480772 RESULT

MeSH Terms

Conditions

Hypotension; Hypoxia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nureddin Yuzkat

  Van Yuzuncu Yil University, Faculty of Medicine, Tusba, Van, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Professor

Model Details: 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).

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: June 24, 2022
• Study Start: May 12, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 30, 2022
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: One year
• Access Criteria: the access can be provided via the e-mail addresses below nyuzkat@gmail.com

Locations

TU (1)