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Clinical Trials/CTRI/2025/09/095229
CTRI/2025/09/095229Not yet recruitingPhase 2

Comparison of reversal of vecuronium induced neuromuscular blockade using sugammadex 100mg and neostigmine 2.5mg in surgery under general anaesthesia.

Jawaharlal Nehru Medical College1 site in 1 country55 target enrollmentStarted: October 13, 2025Last updated:

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

Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Avnish Kaur Saluja

Datta meghe institute of higher education and research

Study Sites (1)

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