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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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The Effect of BIS-guided Propofol Induction on the Peroperative and Postoperative Hemodynamic Response in Patients With Cardiac Risk in Ear-nose-throat Surgery.

Conditions
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Anesthesia, General

Intervention / Treatment
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* Drug: Propofol
* Device: Bispectral Index Monitor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Drug: Propofol Device : Bispectral Index Monitor
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator<br>Active Comparator: Control Patients with cardiac disaese receive general anesthesia with Propofol Interventions: Drug: Propofol | Drug: Propofol<br>* Propofol<br>|
| Experimental: Experimental<br>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 | Drug: Propofol<br>* Propofol<br>Device: Bispectral Index Monitor<br>* Bispectral Index Monitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Propofol consumption | amount of Propofol consumption during the induction of anesthesia and perioperative period with or without BIS monitoring | 30 minutes-2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic alterations | to observe hemodynamic alterations during propofol induction with or without BIS monitoring . | 30 minutes- 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BIS, propofol, anesthesia