Conscious sedation for balloon mitral valvotomy: A Comparison of Fentanyl Vs Sufentanil.
Phase 4
Completed
- Conditions
- Health Condition 1: null- Patients with Mitral Stenosis with mitral valve area 0.8-1sq.cm.
- Registration Number
- CTRI/2016/08/007142
- Lead Sponsor
- Seth G S Medical College and KEM Hospital Parel Mumbai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Patients with Mitral stenosis with mitral valve area of 0.8-1.0sq.cm.
Exclusion Criteria
Patients less than 15yrs and more than 45yrs.
Patients with anticipated difficult intubation
Patients with uncompensated liver and kidney disease
Patients with hemodynamic instability and congestive cardiac failure
Patients with history of bronchial asthma
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of Fentanyl and Midazolam Infusion Vs Sufentanil and Midazolam infusion for Balloon Mitral Valvotomy with respect to <br/ ><br>1)Analgesia <br/ ><br>2)Sedation <br/ ><br>3)Patient satisfaction <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Comapre the efficacy <br/ ><br> <br/ ><br>Timepoint: Analgesic efficacy will be assessed from the number of bolus doses required during the procedure, inappropriate movements during the procedure and from the VAS score patients opinion one hour after the procedure. <br/ ><br>Quality of sedation was assessed during the procedure. <br/ ><br>Patient satisfaction was assessed by VAS score one hour after the procedure.
- Secondary Outcome Measures
Name Time Method 1)Dicharge fitness <br/ ><br>2)Effect on cardiorespiratory parameters <br/ ><br>3)Respiratory complications like oxygen desaturation hypercarbia airway obstruction and snoring <br/ ><br>2)Excessive pain or distress <br/ ><br>3)Any reruns due to patients inability to lie still were noted. <br/ ><br>3)Airway obstruction <br/ ><br>4)Loss of consciousnessTimepoint: Discharge fitness was assessed two hours after the procedure. <br/ ><br>Effect on cardiorespiratory parameters was assessed throughout the procedure. <br/ ><br>Respiratory complications like desaturation hypercarbia airway obstruction chest wall rigidity due opioids were watched for throughout the procedure. <br/ ><br>Other complications like excessive pain or distress any reruns airway obstruction loss of consciousness were watched for.