The Effect of BIS-guided Propofol Induction on Hemodynamic Response in Patients With Cardiac Risk.

Istanbul University - Cerrahpasa (IUC)

Status: Unknown

Conditions: Anesthesia, General

Treatments: Device: Bispectral Index Monitor; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT04729465

10/01/2020-5208

Details and patient eligibility

About

Anesthesia induction will be started by monitoring ECG, non-invasive artery monitoring, peripheral oxygen saturation and BIS for all patients who are taken to the operating room without sedation. The patients were divided into 2 groups: Group P; Propofol 2 mg / kg bolus (in 10 seconds), Group B; Propofol will be started as an infusion dose of 0,25 mg / kg / min and will be discontinued when the BIS reaches a minimum value of 60. Noninvasive arterial blood pressure and heart rate will be measured at 2-minute intervals during the first 10 minutes of induction and then at 15th , 20th ,30th and 60th minutes peroperatively. Hypotension; mean arterial pressure (MAP) <60 mmHg, bradycardia heart rate <60 / min, hypertension MAP> 120 mmHg and tachycardia heart rate> 100 / min were defined. The difference of changes, their duration, the difference between the maximal value and the baseline value, and the number of occurrences of hypotension, hypertension, and arrhythmias during the entire induction and perioperative period will be recorded. Noninvasive arterial blood pressure and heart rate measurements of the patients will be made in the postoperative period at 5th , 15th , 30th minutes and at 1st , 2nd , 4th , and 24th hours. At the end of the 1st month, it will be questioned whether the patients encounter a cardiovascular problem that will require treatment or hospitalization in the period following the surgery. All patients will be started with 5 ml / kg / hour IV crystalloid infusion. When the MAP falls below 60 mmHg during induction, the patient will be given the Trendelenburg position and the crystalloid infusion will be increased to 10 ml / kg / hour, and vasoconstrictor drug will be added if the hypotension does not improve within the following 10 minutes.

Full description

surgeries performed on patients participating in the study

minor elective ear nose throat surgery (microlaryngeal surgery, biyopsy for ENT malignancy, myringoplasty)

exclusion criteria;history of stroke, stupor, dementia, long-term use of central nervous system (CNS) activator drugs, benzodiazepines and/or opiates therapy, and pregnant females

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The patients with a cardiovascular problem requiring ENT surgery lasting less than 2 hours

Exclusion criteria

Patients having history of stroke, stupor, dementia, long-term use of central nervous system (CNS) activator drugs, benzodiazepines and/or opiates therapy, and pregnant females were excluded from the study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Active Comparator

Active Comparator group

Description:

Active Comparator: Control Patients with cardiac disaese receive general anesthesia with Propofol Interventions: Drug: Propofol

Treatment:

Drug: Propofol

Experimental

Experimental group

Description:

Experimental: Bispectral Index Monitor Patients with cardiac disease receive a general anesthesia with Propofol where the amount of anesthetics administered is decided taking into consideration the Bispectral Index Monitor. Interventions: Drug: Propofol Device: Bispectral Index Monitor

Treatment:

Device: Bispectral Index Monitor

Drug: Propofol