Comparison of reversal of vecuronium induced neuromuscular blockade using sugammadex 100mg and neostigmine 2.5mg in surgery under general anaesthesia.
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- To compare the time of complete recovery (TOF=0.9) from vecuronium induced shallow neuromuscular blockade following administration of sugammadex 100mg with neostigmine 2.5mg on reversal to muscle relaxant.
Study Overview
Brief Summary
Neuromuscular blocking agents are essential to ensure optimal surgical conditions during general
anesthesia. Sugammadex, a selective binding agent, is widely used to reverse neuromuscular
blockade. While weight-based dosing (2 mg/kg for shallow blockade) is recommended, many
clinicians administer a fixed dose of 100 mg in clinical practice. Other option is the use of
neostigmine 2.5mg for reversal of neuromuscular blockade. This study aims to compare efficacy
of reversal using sugammadex 100mg with neostigmine 2.5mg after surgery in General
Anaesthesia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA I,II, III Patients willing to participate in the study Prolonged duration surgery under general anaesthesia for more than four hours.
- •Preoperative oxygen saturation of 98-100 percent on room air.
Exclusion Criteria
- •Lack of valid informed written consent.
- •ASA grade IV.
- •Patients with bleeding disorders.
- •Patients on anticoagulants.
- •Allergies to food and drugs.
- •Patients with cardiac, renal, hepatic and respiratory co-morbidities.
- •Patients on medication known to interact with neuromuscular blocking drugs e.g.: Antibiotics (aminoglycosides, tetracycline), antidepressants, anticonvulsants, antiarrhythmics (calcium channel blockers and quinidine) and magnesium sulphate and patients with known allergy to cisatracurium.
Outcomes
Primary Outcomes
To compare the time of complete recovery (TOF=0.9) from vecuronium induced shallow neuromuscular blockade following administration of sugammadex 100mg with neostigmine 2.5mg on reversal to muscle relaxant.
Time Frame: 2 hours
Secondary Outcomes
- 1. To compare the number of patients requiring top-up doses of respective reversal agent to reach a Train-of-Four (TOF) ratio of more than equal to 0.9 in both groups.(2 . To compare the incidence of residual neuromuscular blockade, recurarization and any adverse effects associated between two groups.)
Investigators
Dr Avnish Kaur Saluja
Datta meghe institute of higher education and research