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Comparison of effects of adding drugs to local anaesthestic during spinal anaesthesia in patients having cardiac disease versus normal healthy patients.

To compare the hemodynamic effects of low dose intrathecal bupivacaine with 25 microgram butorphanol in cardiac versus non cardiac patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023427
Enrollment
60
Registered
2020-02-19
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: I259- Chronic ischemic heart disease, unspecified Health Condition 2: I110- Hypertensive heart disease with heart failure Health Condition 3: I709- Other and unspecified atherosclerosis Health Condition 4: I089- Rheumatic multiple valve disease,unspecified

Interventions

Intervention1: Intrathecal injection of low dose Bupivacaine: To study the hemodynamic effects of low dose intrathecal bupivacaine with 25 microgram butorphanol in cardiac patients and their compariso

Sponsors

Shri Guru Ram Das institute of health sciences and research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Cardiac patients of either sex belonging to ASA grade II and III Patients with intermediate clinical predictors with moderate or excellent functional capacity (METS >4) undergoing intermediate or low risk surgical procedures. Patients with intermediate clinical predictors with poor functional capacity (METS Patients with minor or no clinical predictors with moderate or excellent functional capacity (METS >4) undergoing intermediate or low risk surgical procedures. Non cardiac patients will be ASA grade I and II.

Exclusion criteria

Exclusion criteria: 1. Patientâ??s refusal to participate in the study. 2. Pregnancy 3. ASA grade IV for cardiac patients and ASA grade III and IV for non cardiac patients. 4. Patients in acute decompensated left/right ventricular failure, pulmonary edema 5. Severe reduction in LVEF of 6. BMI > 30 6. Patients with contraindications to SAB such as local infections at the site of lumbar puncture, severe spinal deformity, severe hypovolemia , increased intra-cranial pressure (i.e. brain tumor or recent head injury) 7. Patients with active chest infection 8. Patients with major clinical predictors: unstable coronary syndromes, decompensated CHF, significant arrhythmias (2nd and 3rd degree atrio-ventricular block, symptomatic ventricular arrhythmias, supraventricular arrhythmias with uncontrolled ventricular rate), severe valvular diseases like severe aortic/mitral stenosis) 9. Severe uncorrected anemia 10. Patients with known coagulopathies. 11. Deranged coagulation profile INR >1.5 and aPTT >40. 12. Patients with history of drug allergy to opioids/local anaesthetics. 13. Patients with bare metal stent 14. Patients having intermediate/minor or no clinical predictors presenting for high risk surgical procedures. 15. Patients with no clinical predictors having high cardiac risk on non invasive testing.

Design outcomes

Primary

MeasureTime frame
comparison of hemodynamic changes(BP, HR,MAP, ECG) in cardiac VERSUS non cardiac patientsTimepoint: every 5 min till 2 hours intraoperative every 15 min till 2 hours postoperative every 2 hours till 24 hrs postoperative—

Secondary

MeasureTime frame
comparison of perioperative morbidity and mortality in cardiac versus non cardiac patientsTimepoint: 3 days postoperatively—

Countries

India

Contacts

Public ContactDr Deepika Arora

Shri Guru Ram Das Institute of Medical Sciences and Research

drruchisgrd@gmail.com9814320805

Outcome results

None listed

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