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

NCT04729465 | Unknown

• 1 other identifier: 10/01/2020-5208
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anesthesia, General

Keywords

BIS, propofol, anesthesia

Outcome Measures

Primary Outcomes (1)

• Propofol consumption

  amount of Propofol consumption during the induction of anesthesia and perioperative period with or without BIS monitoring

  30 minutes-2 hours

Secondary Outcomes (1)

• Hemodynamic alterations

  30 minutes- 2 hours

Study Arms (2)

Active Comparator

ACTIVE COMPARATOR

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

Drug: 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; Device: Bispectral Index Monitor

Interventions

Propofol DRUG

Propofol

Active Comparator; Experimental

Bispectral Index Monitor DEVICE

Bispectral Index Monitor

Experimental

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

MeSH Terms

Interventions

Propofol; Consciousness Monitors

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology, Resident, MD.

Model Details: Drug: Propofol Device : Bispectral Index Monitor

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 28, 2021
• Study Start: February 8, 2021
• Primary Completion: July 10, 2021
• Study Completion: August 10, 2021
• Last Updated: February 3, 2021

Record last verified: 2021-01