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A clinical trial to compare two drugs, Sugammadex and Neostigmine, to reverse muscle relaxation in patients undergoing gall bladder removal surgery under general anaesthesia

Comparative evaluation of Sugammadex versus Neostigmine for reversal of neuromuscular blockade in patients undergoing cholecystectomy under general anaesthesia - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056371
Enrollment
60
Registered
2023-08-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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: Neuromuscular blockade reversal using Sugammadex: At the end of surgery, we will give Injection Sugammadex 2mg/kg intravenously for reversal of neuromuscular blockade in 30 patients (Gr

Sponsors

Department of Anaesthesia
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing elective surgeries under general anaesthesia ASA Grade I & II Duration of anaesthesia <2 hours.

Exclusion criteria

Exclusion criteria: Patients with known allergies to multiple drugs. Pregnant/Nursing mother. Age 60 years. Patients with history of renal or hepatic disease. Patients with a history of arrhythmia, neurological disorder, acute or chronic alcoholism or neuromuscular disorders, patients with cardiac pacemaker. Allergic/Hypersensitivity to Neostigmine or Sugammadex. Diaphragmatic palsy Emergency, Cardiac, liver or lung transplant surgery. Morbidly obese patients (BMI >= 35.5 kg/m²) On current Medications with drugs having effects on nervous system. Patient refusal Severe bradycardia. Thrombocytopenia. Blood Dyscrasias or coagulopathy

Design outcomes

Primary

MeasureTime frame
To compare the safety & efficacy of sugammadex versus neostigmine for reversal of neuromuscular blockade. To assess recovery time from the administration of study drug to train of four ratio (TOF) of 0.9. To assess post-operative residual paralysis. To compare hemodynamic effects of sugammadex & neostigmineglycopyrrolate combination in adult patients.Timepoint: Time from administration of muscle relaxant till 6 hours after surgery

Secondary

MeasureTime frame
Drug related adverse events (if any)Timepoint: Time from administration of muscle relaxant till 6 hours after surgery

Countries

India

Contacts

Public ContactDr Anu Sharma

Government Medical College, Amritsar

anu.anaesthesia.97@gmail.com9814185884

Outcome results

None listed

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