Studying the effects of two different hypnotic agents (Propofol & Etomidate) on relaxation function of left heart
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2021/06/034090
- Brief Summary
After obtaining approval from Post-graduate Research Monitoring Committee and Institute Ethics Committee, this study will be registered in Clinical Trial Registry-India. Adult patients (>18 years) with ASA PS 1 or 2, undergoing surgery under general anaesthesia will be included in this study after obtaining informed written consent. Patients will be premedicated with tablet diazepam 0.1 mg.kg-1 on the night prior to surgery and on the morning of surgery. Patients will be kept fasting as per American Society of Anaesthesiologists (ASA) guidelines. Baseline vital parameters will be obtained after connecting the patients with ECG, non-invasive blood pressure (NIBP) and pulse oximetry. Low frequency echocardiography probe (1-5 mHz, My LabX5, Esaote, Genova, Italy) will be used to record the study parameters. LV diastolic function will be assessed by an anaesthesiologist who has experience in transthoracic echocardiography (TTE) at least for one year. Apical-four chamber (A4C) view will be obtained by placing the echocardiographic probe over the apical impulse and by keeping the probe horizontally with orientation marker facing left side. Pulse wave Doppler sampling will be obtained at mitral valvular leaflet tips to obtain E wave which represents early passive diastolic filling and A wave that results from atrial contraction. Deceleration time will be obtained from E wave. E/A ratio will be calculated. Tissue Doppler Imaging will be utilized to measure mitral annular peak velocities. Tissue Doppler sampling will be done at septal mitral annulus to obtain septal eˊ; it will be done in lateral mitral annulus to obtain lateral eˊ. The machine will calculate average E/eˊ. Left atrial (LA) maximal volume index will be obtained by measuring its length and transverse diameter in A4C or apical 2 chamber view, one to two frames prior to opening of the mitral valve. Tricuspid regurgitation maximum velocity will be obtained by placing the continuous wave Doppler at the regurgitant jet area (can be located by colour flow Doppler) in A4C view. After obtaining these baseline echocardiographic variables, patient will be induced. All patients will receive Ringer’s lactate at rate of 10 ml.kg-1.hour-1after securing intravenous line. Patients in group P will be induced with 2 mg.kg-1 of propofol and patients in group E will be induced with 0.3 mg.kg-1 of etomidate. Induction agent will be administered over the span of 30 seconds. Ventilation of the patient will be assisted with breathing circuit of anaesthesia workstation (with FiO2 of 1.0), if required. Depth of anaesthesia will be monitored by BIS (Bispectral Index) every minute till the end of this study. Heart rate, NIBP and SpO2 will be monitored for every minute till the end of this study. The aforementioned parameters will be measured in sequence, 30 seconds after administration of the induction drugs. After completion of this study, patients will be managed as per the discretion of the attending anaesthesiologist.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 168
Adult patients (>18 years of age) with ASA PS 1 or 2 requiring surgery under general anaesthesia will be recruited in this study.
Patients with pre-existing cardiac lesions will be excluded from this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of the changes in E/e prime between the groups After administration of the study drug, E/e prime will be measured and its change with baseline (before administration of the study drug) will be studied.
- Secondary Outcome Measures
Name Time Method 1) Comparison of change in e prime velocities between the groups 2) Comparison of change in E/A between the groups
Trial Locations
- Locations (1)
Jawaharlal Institute of Postgraduate Medical Education and Research
🇮🇳Pondicherry, PONDICHERRY, India
Jawaharlal Institute of Postgraduate Medical Education and Research🇮🇳Pondicherry, PONDICHERRY, IndiaDr ShanmugappriyaPrincipal investigator8124656802shanmugappriya29@gmail.com