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

Not Applicable

• Conditions: Health Condition 1: I259- Chronic ischemic heart disease, unspecifiedHealth Condition 2: I110- Hypertensive heart disease with heart failureHealth Condition 3: I709- Other and unspecified atherosclerosisHealth Condition 4: I089- Rheumatic multiple valve disease,unspecified

• Registration Number: CTRI/2020/02/023427
• Lead Sponsor: Shri Guru Ram Das institute of health sciences and research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 <4) undergoing low/intermediate risk surgical procedures if non invasive testing suggests a low cardiac risk.

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

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 <30%

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 < 4-6 weeks ago and drug eluting stents < 12 months ago.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
comparison of hemodynamic changes(BP, HR,MAP, ECG) in cardiac VERSUS non cardiac patientsTimepoint: every 5 min till 2 hours intraoperative <br/ ><br>every 15 min till 2 hours postoperative <br/ ><br>every 2 hours till 24 hrs postoperative

Secondary Outcome Measures

Name	Time	Method
comparison of perioperative morbidity and mortality in cardiac versus non cardiac patientsTimepoint: 3 days postoperatively