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

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

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia, General
• Intervention / Treatment: Drug: Propofol; Device: Bispectral Index Monitor

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator; Active Comparator: Control Patients with cardiac disaese receive general anesthesia with Propofol Interventions: Drug: Propofol	Drug: Propofol; Propofol
Experimental: Experimental; 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; Propofol; Device: Bispectral Index Monitor; Bispectral Index Monitor

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (Anticipated): February 8, 2021
• Primary Completion (Anticipated): July 10, 2021
• Study Completion (Anticipated): August 10, 2021

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: January 30, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: BIS, propofol, anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: 10/01/2020-5208

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No