Conscious sedation for balloon mitral valvotomy: A Comparison of Fentanyl Vs Sufentanil.

Conscious Sedation with Fenatnyl and Midazolam Infusion Vs.Sufentanil and Midazolam Infusion for Balloon Mitral Valvotomy.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/08/007142

Enrollment

Registered

2016-08-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Patients with Mitral Stenosis with mitral valve area 0.8-1sq.cm.

Interventions

Intervention1: Intervention: Sufentanil: Intervention:Sufentanil and Midazolam Infusion for Conscious Sedation for Balloon Mitral Valvotomy. Bolus dose of Sufentanil was 0.1mcg/kg and Bolus dose of M

Eligibility

Inclusion criteria

Inclusion criteria: Patients with Mitral stenosis with mitral valve area of 0.8-1.0sq.cm.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Comparison of Fentanyl and Midazolam Infusion Vs Sufentanil and Midazolam infusion for Balloon Mitral Valvotomy with respect to 1)Analgesia 2)Sedation 3)Patient satisfaction Comapre the efficacy 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. Quality of sedation was assessed during the procedure. Patient satisfaction was assessed by VAS score one hour after the procedure.	—

Measure

Time frame

Comparison of Fentanyl and Midazolam Infusion Vs Sufentanil and Midazolam infusion for Balloon Mitral Valvotomy with respect to 1)Analgesia 2)Sedation 3)Patient satisfaction Comapre the efficacy 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. Quality of sedation was assessed during the procedure. Patient satisfaction was assessed by VAS score one hour after the procedure.

—

Secondary

Measure	Time frame
1)Dicharge fitness 2)Effect on cardiorespiratory parameters 3)Respiratory complications like oxygen desaturation hypercarbia airway obstruction and snoring 2)Excessive pain or distress 3)Any reruns due to patients inability to lie still were noted. 3)Airway obstruction 4)Loss of consciousnessTimepoint: Discharge fitness was assessed two hours after the procedure. Effect on cardiorespiratory parameters was assessed throughout the procedure. Respiratory complications like desaturation hypercarbia airway obstruction chest wall rigidity due opioids were watched for throughout the procedure. Other complications like excessive pain or distress any reruns airway obstruction loss of consciousness were watched for.	—

Measure

Time frame

1)Dicharge fitness 2)Effect on cardiorespiratory parameters 3)Respiratory complications like oxygen desaturation hypercarbia airway obstruction and snoring 2)Excessive pain or distress 3)Any reruns due to patients inability to lie still were noted. 3)Airway obstruction 4)Loss of consciousnessTimepoint: Discharge fitness was assessed two hours after the procedure. Effect on cardiorespiratory parameters was assessed throughout the procedure. Respiratory complications like desaturation hypercarbia airway obstruction chest wall rigidity due opioids were watched for throughout the procedure. Other complications like excessive pain or distress any reruns airway obstruction loss of consciousness were watched for.

—

Countries

India

Contacts

Public ContactDr Shailendra Modak

Seth GS Medical College and KEM Hospital,Parel Mumbai.

deepakane_22@yahoo.com9619313331

Outcome results

None listed

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