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The Effects of Nicardipine and Esmolol Applied for Controlled Hypotension

Primary Purpose

Hypotension, Surgery-Complications, Oxygen Deficiency

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Controlled hypotention
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension focused on measuring Controlled hypotension, rhinoplasty, esmolol, nicardipine, regional renal oxygenation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Van yuzuncu Yıl University, Dursun Odabas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Grup E

Grup N

Arm Description

Patients given esmolol infusion

Patients given nicardipine infusion

Outcomes

Primary Outcome Measures

Level of hypotension
Measuring mean blood pressures
Monitoring of renal oxygen saturation
Measurement of regional renal oxygenation

Secondary Outcome Measures

Full Information

First Posted
May 12, 2022
Last Updated
September 23, 2022
Sponsor
Yuzuncu Yıl University
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1. Study Identification

Unique Protocol Identification Number
NCT05430724
Brief Title
The Effects of Nicardipine and Esmolol Applied for Controlled Hypotension
Official Title
The Effects of Nicardipine and Esmolol Applied for Controlled Hypotension in Rhinoplasty Procedures on Hemodynamics and Regional Renal Oxygenation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Surgery-Complications, Oxygen Deficiency
Keywords
Controlled hypotension, rhinoplasty, esmolol, nicardipine, regional renal oxygenation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Grup E
Arm Type
Active Comparator
Arm Description
Patients given esmolol infusion
Arm Title
Grup N
Arm Type
Active Comparator
Arm Description
Patients given nicardipine infusion
Intervention Type
Procedure
Intervention Name(s)
Controlled hypotention
Intervention 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).
Primary Outcome Measure Information:
Title
Level of hypotension
Description
Measuring mean blood pressures
Time Frame
1 year
Title
Monitoring of renal oxygen saturation
Description
Measurement of regional renal oxygenation
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nureddin Yuzkat
Organizational Affiliation
Van Yuzuncu Yil University, Faculty of Medicine, Tusba, Van, Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Van yuzuncu Yıl University, Dursun Odabas Medical Center
City
Van
ZIP/Postal Code
65080
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
27542543
Citation
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.
Results Reference
background
PubMed Identifier
8869676
Citation
Pilli G, Guzeldemir ME, Bayhan N. Esmolol for hypotensive anesthesia in middle ear surgery. Acta Anaesthesiol Belg. 1996;47(2):85-91.
Results Reference
result
PubMed Identifier
25480772
Citation
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.
Results Reference
result

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The Effects of Nicardipine and Esmolol Applied for Controlled Hypotension

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