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STUDY OF INTRAVENOUS SILDENAFIL ON PULMONARY HYPERTENSION IN PATIENTS UNDERGOING MITRAL VALVE REPLACEMENT SURGERY

COMPARITIVE STUDY OF INTRAVENOUS SILDENAFIL ON PULMONARY HYPERTENSION IN PATIENTS UNDERGOING MITRAL VALVE REPLACEMENT SURGERY , A PROSPECTIVE RANDOMIZED CONTROL STUDY ,DEPARTMENT OF ANAESTHESIA, SMS MEDICAL COLLEGE, JAIPUR - nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061106
Enrollment
70
Registered
2024-01-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: I050- Rheumatic mitral stenosis

Interventions

Intervention1: Intravenous Sildenafil infusion: Intravenous Sildenafil infusion intraoperative once at dose 0.07mg/kg/hr. after sternotomy Control Intervention1: normal saline infusion: Intravenous no

Sponsors

Department of anaesthesiology
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1.Severe hypotension on the day or before the day of surgery(SBP 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 6.Ongoing or prior malignancy. 7.History of allergy to study drug

Design outcomes

Primary

MeasureTime frame
1.Mean Pulmonary artery pressure 2.Pulmonary vascular resistance 3.Heart rate 4. Systolic diastolic and mean arterial pressureTimepoint: 1.Cardiac index 2.Central venous pressure 3.Side effects if any

Secondary

MeasureTime frame
1.Cardiac index 2.Central venous pressure 3.Side effects if anyTimepoint: T1- before induction T2- After induction T3- after off pump T4- After 6 hours of surgery T5- After 12 hours of surgery T6-After 24 hours of surgery

Countries

India

Contacts

Public ContactANJUM SAIYED

SMS MEDICAL COLLEGE

Dranjumsaiyed@gmail.com9214021930

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026