A clinical trial to compare two drugs, Sugammadex and Neostigmine, to reverse muscle relaxation in patients undergoing gall bladder removal surgery under general anaesthesia
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2023/08/056371
- Lead Sponsor
- Department of Anaesthesia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patients undergoing elective surgeries under general anaesthesia
ASA Grade I & II
Duration of anaesthesia <2 hours.
Patients with known allergies to multiple drugs.
Pregnant/Nursing mother.
Age <18 years or >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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the safety & efficacy of sugammadex versus neostigmine for <br/ ><br>reversal of neuromuscular blockade. <br/ ><br>To assess recovery time from the administration of study drug to train of four <br/ ><br>ratio (TOF) of 0.9. <br/ ><br>To assess post-operative residual paralysis. <br/ ><br>To compare hemodynamic effects of sugammadex & neostigmineglycopyrrolate combination in adult patients.Timepoint: Time from administration of muscle relaxant till 6 hours after surgery
- Secondary Outcome Measures
Name Time Method Drug related adverse events (if any)Timepoint: Time from administration of muscle relaxant till 6 hours after surgery