Skip to content

To see the speed of anaesthesia with the drug thiopentone and compare it in patients with different heart lesions

To compare the speed of intravenous induction of anaesthesia using thiopentone in adult patients with and without valvular heart disease.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/03/051102
Enrollment
144
Registered
2023-03-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: I259- Chronic ischemic heart disease, unspecified Health Condition 2: I080- Rheumatic disorders of both mitraland aortic valves

Interventions

Intervention1: NIL: NIL

Sponsors

ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All elective cardiac surgeries in patients between 18-60 years with Rheumatic heart disease with Cardiac Anaesthesia Risk Evaluation (CARE) Score 1 and 2 shall be included in this study. 2. All elective cardiac surgeries in patients between 18-60 years with Coronary artery disease with Cardiac Anaesthesia Risk Evaluation (CARE) Score 1 and 2 shall be included in this study.

Exclusion criteria

Exclusion criteria: 1. Emergency surgery 2. Redo surgery 3. Patient in shock, sepsis or disseminated intravascular coagulopathy 4. Patient in congestive heart failure 5. Renal dysfunction 6. Severe liver disease 7. Patients with body mass index = 40 8. Conditions affecting the basal metabolic rate i.e hypothyroidism, hyperthyroidism, pregnancy or pheochromocytoma, febrile illness 9. Patients with EF 10. Patients on mechanical ventilation 11. Patients with allergy to thiopentone 12. Patients using any long term CNS depressants or stimulants

Design outcomes

Primary

MeasureTime frame
•To compare the speed of induction of anaesthesia, as determined by the time taken for loss of eyelash reflex and achievement of BIS value 60, in patients with and without VHD.Timepoint: The time of induction will be determined by the time taken from the start of thiopentone injection to loss of eyelash reflex and decrease in BIS value below 60. BIS values will be recorded at 15 s intervals for the 1st min (T1–T4) followed by 30 s interval for the next 1 min (T5–T6) during the period of induction.

Secondary

MeasureTime frame
• To study and compare the changes in hemodynamic parameters before and after the induction of anaesthesia in patients with VHD, as measured by blood pressure, heart rate, index of contractility (ICON), cardiac index (CI) and stroke volume.Timepoint: Baseline readings of the following hemodynamic parameters: Heart rate, systolic/diastolic/mean blood pressure, stroke volume, stroke index, Cardiac output, Cardiac index, Index of contractility will be also be noted at 15s intervals for the 1st min followed by 30s interval for next minute. Adverse effects, if any will also be evaluated.

Countries

India

Contacts

Public ContactTANYA MITAL

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI

suruchi_hasija@hotmail.com9818515020

Outcome results

None listed

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