Clinical trial

The Effect of Bispectral Index Controlled Sedation on QT Distance and P Dispersion in ECG in Patients Having Bronchoscopy in the Intensive Care Unit

Name
BAIBU-MF-GH-EO-001
Description
Fiberoptic bronchoscopy (FOB) is one of the most useful procedures for diagnosing and treating respiratory illnesses to figure out symptoms like hemoptysis, wheezing, or cough. Furthermore, FOB is a frequent method, in intensive care units, for both diagnoses of ventilator-associated pneumonia (VAP) and treatment of atelectasis with bedside sedation.) Propofol is often used in anesthesia for endoscopic treatments. Using propofol for deep anesthesia may be indicated to prevent the patient from feeling discomfort before FOB and to reduce the chance of complications. Although major complications of FOB such as hypoxia and pneumothorax are known, there are limited studies showing its effects on cardiac hemodynamics. The cardiac effects of laryngoscope and intubation were investigated by using different anesthetic agents. In this study, we evaluated the effect of bronchoscopy with BIS-controlled sedation on ECG in ICU patients by monitoring the QT interval and P interval.
Trial arms
Trial start
2022-06-25
Estimated PCD
2023-12-25
Trial end
2024-03-25
Treatment
Midazolam
Before the procedure, all patients were given i.v. 0:02 - 0:04 mg / kg midazolam (zolamide 15 mg / 3 mL, and medications, Turkey) will be administered.
Arms:
Group M
Other names:
Zolamid
Propofol
Propofol 0.5 mg/kg bolus dose will be administered to Group II. Maintenance will be provided with 60 mcg/kg/min propofol infusion, and the propofol infusion dose will be increased by 10 mcg/kg/min by titration until the BIS value is 40-60 during the procedure.
Arms:
Group P
Other names:
Dormofol
Size
40
Primary endpoint
P wave dispersion (PWD)
Before the procedure
P wave dispersion (PWD)
After the procedure of the first minute
P wave dispersion (PWD)
After the procedure of the fifth minute
P wave dispersion (PWD)
After the procedure of the tenth minute
P wave dispersion (PWD)
After the procedure of the fifteenth minute
QTc (Corrected QT interval) and QTd (QT dispersion) values
Before the procedure
QTc (Corrected QT interval) and QTd (QT dispersion) values
After the procedure of the first minute
QTc (Corrected QT interval) and QTd (QT dispersion) values
After the procedure of the fifth minute
QTc (Corrected QT interval) and QTd (QT dispersion) values
After the procedure of the tenth minute
QTc (Corrected QT interval) and QTd (QT dispersion) values
After the procedure of the fifteenth minute
Eligibility criteria
Inclusion Criteria: \* All intubated patients over 18 years of age Exclusion Criteria: * Patients under the age of 18 * Pregnancy * Patients using sedative drugs in the last 24 hours * Hypersensitivity to the drugs used in the study * Severe cardiac disorder (EF: \< 40) * Patients using drugs that increase the QT interval (quinidine, lithium, procainamide, amiodarone, sotalol, phenothiazine, tricyclic antidepressants, disopyramide) or reduce the QT interval (digitals) * Patients who have hypomagnesemia- hypocalcemia - hypo or hyperthermia - hypo or hypercalcemia - hyperkalemia - hyper or hypothyroidism - myocarditis - mitral heart prolapsus
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'For this study, it was planned to recruit 40 patients who would have FOB in the ICU of Abant İzzet Baysal University Anesthesia. All intubated patients over 18 years of age who do not meet the exclusion criteria will be included. Volume-controlled ventilation modes will be preferred during FOB. The pre-trade-inspired FiO2 will be increased to 100%. During the procedure, mean blood pressure, heart rate, oxygen saturation, respiratory rate, CVP, airway pressure, and BIS will be closely monitored. Enteral feeding will be discontinued at least 6 hours before the procedure. At the end of the procedure, the endotracheal tube position will be checked.\n\nFOB will be performed using mobile bronchoscopy (Storz FB; 5.0 mm outer diameter). All patients will be monitored with BIS (Bispectral Index A-2000, Aspect Medical Systems, Netherlands) to measure the depth of sedation.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-01-31

1 organization

2 products

2 indications

Product
Midazolam
Indication
Atelectasis
Product
Propofol