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A clinical trial to compare the effectiveness of two drugs (sugammadex vs neostigmine-glycopyrolate)in patient undergoing cardiac surgeries.

Efficacy and safety of sugammadex reversal following cardiac surgery A randomized control study. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072509
Enrollment
172
Registered
2024-08-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Reversal of Neuromuscular Blockade by Sugammadex: Total duration of study will be two years.Reversal of neuromuscular blockade by using the drug Sugammadex following cardiac surgery usi

Sponsors

Vignesh D
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Elective CABG or AVR surgeries or both . ASA grade 1,2,3,4 . Ejection fraction of more than or equal to 45%.

Exclusion criteria

Exclusion criteria: Participant refusal. Emergency cases. Ejection fraction of less than 45%,moderate or severe RV failure . CKD with moderate to severe reduced GFR (less than 30ml/min/1.73m2). Participant with neuromuscular disorders. History of adverse reaction to study drug. Chronic opioid use. BMI of more than 35kg/m2

Design outcomes

Primary

MeasureTime frame
To compare the efficacy and safety of sugammadex vs neostigmine-glycopyrolate in reversal of neuromuscular blockade following cardiac surgeries.Timepoint: TOF will be measured just before drug administration, at the time of extubation and at interval of 3,5,10 minutes after extubation.

Secondary

MeasureTime frame
To compare the hemodynamic parameters such as Heart rate,systolic blood pressure,diastolic blood pressure,SpO2 between sugammadex & neostigmine glycopyrolate group.Timepoint: At the time of extubation,3 min,5 min & 10 min after extubation.

Countries

India

Contacts

Public ContactVignesh D

Kovai Medical Centre and Hospital

jipmerramesh@gmail.com9943480966

Outcome results

None listed

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