The Effects of Nicardipine and Esmolol Applied for Controlled Hypotension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-12

Study Completion Date

2022-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Controlled Hypotension on Cerebral Oxygen Saturation

NCT02967029

Hypotension Drug-Induced Cerebral Oxygen Saturation

COMPLETED PHASE4

Noradrenaline Versus Standard Blood Pressure Management for Perioperative Hypotension in Non-cardiac Surgery

NCT06885268

Blood Pressure Management Intraoperative Hypotension Non-cardiac Surgery

RECRUITING PHASE3

Norepinephrine Prevent Post-induction Hypotension in High-risk Patients

NCT06028256

Anesthesia Blood Pressure Norepinephrine

UNKNOWN PHASE4

The Choice of Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-Cardiac Surgery

NCT06802224

Anesthesia Surgery With General Anesthesia Noncardiac Surgery +4 more

RECRUITING PHASE4

Therapeutic Study Evaluating the Efficacy of Noradrenaline in the Prevention of Hypotension Related to Intubation for Cardiac or Thoracic Surgery

NCT05335954

Cardiac Disorder Hypotension

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypotension Surgery-Complications Oxygen Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Grup E

Patients given esmolol infusion

Group Type ACTIVE_COMPARATOR

Controlled hypotention

Intervention Type 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 N

Patients given nicardipine infusion

Group Type ACTIVE_COMPARATOR

Controlled hypotention

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No