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To asses the effect of spinal morphine on inflammatory markers and clinical outcome in patients undergoing open heart surgery

To evaluate the effect of intrathecal morphine on inflammatory markers and clinical outcome in patients undergoing open heart surgery :A Randomised controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055338
Enrollment
100
Registered
2023-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Health Condition 1: I39- Endocarditis and heart valve disorders in diseases classified elsewhere Health Condition 2: I978- Other intraoperative and postprocedural complications and disorders of the circulatory system, not elsewhere classified

Interventions

Intervention1: Addition of intrathecal morphine on inflammatory markers and clinical outcome in patients undergoing open heart surgery: The patients in group A will be receiving intrathecal morphine o

Sponsors

All India Institute of Medical sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex , aged 18 and above belonging to American society of anaesthesiologists (ASA) physical status II-IV and scheduled for valve replacement surgery under cardiopulmonary by pass will be included

Exclusion criteria

Exclusion criteria: Emergency surgery ,combined CABG and valvular surgery , prior cardiac surgery left ventricular fraction LVEF < 0.5 , prospective mechanical ventilation intra aortic balloon pump ,chronic liver disease and patients having any contraindication for intrathecal injection will be excluded

Design outcomes

Primary

MeasureTime frame
To compare the level of IL-6 between the groups at o & 24 hours after surgeryTimepoint: To compare the level of IL-6 between the groups at o & 24 hours after surgery

Secondary

MeasureTime frame
1 To compare the platelet to lymphocyte ratio (PLR) between the groups 2 To compare the neutrophil to lymphocyte ratio (NLR) between the groups 3 To compare the CRP between the groups 4 To compare the need of inotropic support between the groups 5 Time to extubation between the groups 6 To compare VAS scores between the groups 7 Need of analgesia in 24 hours between the groups 8 To compare length of ICU stay between the groups 9 To compare all cause mortality between the groupsTimepoint: To compare the outcomes between the groups at 0 & 24 hours after the surgery

Countries

India

Contacts

Public ContactDR PADIGAE PRADEEP KUMAR

All India Institute of Medical Sciences Jodhpur

geethamanoj007@yahoo.co.in9414084584

Outcome results

None listed

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