A clinical trial to compare the effect of two sleep causing drugs namely etomidate and propofol-phenylephrine combination on heart rate and blood pressure in adult patients undergoing open heart surgeries
- Conditions
- Medical and Surgical, (2) ICD-10 Condition: I052||Rheumatic mitral stenosis with insufficiency,
- Registration Number
- CTRI/2022/02/039898
- Lead Sponsor
- Molli Kiran
- Brief Summary
Propofol and etomidate are the two commonly used induction agents in anaesthesia practice. In patients who are critically ill and in patients with cardiovascular disease, etomidate is preferred as it causes less hypotension compared to propofol. But retrospective studies have proposed an association between the use of etomidate for anaesthesia induction and increased risk of mortality, morbidity in septic or critically ill patients.(1) In spite of these concerns, etomidate is favored for induction of anaesthesia in cardiac surgery patients, in whom hemodynamic stability immediately after induction of anaesthesia is paramount.
The important factors producing cardiovascular depression due to propofol are direct myocardial depression and decreased systemic vascular resistance (SVR). Phenylephrine is a pure alpha agonist which increases venous return and SVR which can counter propofol induced vasodilation. In non-cardiac surgery, studies have shown that phenylephrine mixed with propofol when administered for induction of anaesthesia reduces the hypotension due to propofol. (2,3,4)
Our primary hypothesis is that if propofol-phenylephrine combination has non-inferior hemodynamic profiles to that of etomidate, the former can replace the latter.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 64
Adult ASA II-IV patients undergoing elective cardiac surgeries involving valve replacement and/or coronary artery bypass grafting surgeries who are willing to participate in the study.
1.Patients with known allergy to the study drugs 2.Emergency surgeries 3.Patients with anticipated difficult airway and patients who require more than 2 attempts or more than 30 seconds for direct laryngoscopy.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure every 30 sec for the first ten minutes after induction first ten minutes after anaesthesia induction
- Secondary Outcome Measures
Name Time Method number of extra doses of phenyl ephrine needed in both the groups first ten minutes of induction
Trial Locations
- Locations (1)
All India Institute of Medical Sciences, Bhopal
🇮🇳Bhopal, MADHYA PRADESH, India
All India Institute of Medical Sciences, Bhopal🇮🇳Bhopal, MADHYA PRADESH, IndiaMolli KiranPrincipal investigator9441497323mvr934@gmail.com