STUDY OF INTRAVENOUS SILDENAFIL ON PULMONARY HYPERTENSION IN PATIENTS UNDERGOING MITRAL VALVE REPLACEMENT SURGERY
Phase 2
- Conditions
- Health Condition 1: O- Medical and SurgicalHealth Condition 2: I050- Rheumatic mitral stenosis
- Registration Number
- CTRI/2024/01/061106
- Lead Sponsor
- Department of anaesthesiology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Planned to undergo mitral valve replacement surgery
2.Patient willing to give informed consent.
3.Weight between 40-70kg
4.Patient belonging to ASA grade 2 and 3
5.Ejection fraction more than 40%
Exclusion Criteria
1.Severe hypotension on the day or before the day of surgery(SBP <80 mmhg)..
2.Patients with coronary heart disease or those taking nitrates
3.Endocrine,metabolic,neurologic and psychotic disorder
4. tricuspid stenosis
5.Severe hepatic(ALT or AST >3 times the upper limit of normal) or renal dysfunction(creatinine clearance <30 ml/hr), Peptic ulcer or bleeding
6.Ongoing or prior malignancy.
7.History of allergy to study drug
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br/ ><br>1.Mean Pulmonary artery pressure <br/ ><br>2.Pulmonary vascular resistance <br/ ><br>3.Heart rate <br/ ><br>4. Systolic diastolic and mean arterial pressureTimepoint: 1.Cardiac index <br/ ><br>2.Central venous pressure <br/ ><br>3.Side effects if any
- Secondary Outcome Measures
Name Time Method 1.Cardiac index <br/ ><br>2.Central venous pressure <br/ ><br>3.Side effects if anyTimepoint: T1- before induction <br/ ><br>T2- After induction <br/ ><br>T3- after off pump <br/ ><br>T4- After 6 hours of surgery <br/ ><br>T5- After 12 hours of surgery <br/ ><br>T6-After 24 hours of surgery