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Comparison of Sugammadex and Neostigmine for reversal of neuromuscular blockade in children undergoing surgery with general anaesthesia

Comparison of Sugammadex and Neostigmine for reversal of Vecuronium induced neuromuscular blockade in paediatric patients: A prospective randomised study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/050085
Enrollment
240
Registered
2023-02-26
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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: Injection Sugammadex: At the end of surgery, Single dose of 2mg/kg, Intravenously. Control Intervention1: Injection neostigmine and glycopyrrolate / atropine: At the end of surgery,

Sponsors

Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Children of 2 years of age to 12 years of age. 2) ASA Physical status 1,2 and 3 3) Those requiring general anaesthesia with endotracheal intubation for their elective surgical procedure.

Exclusion criteria

Exclusion criteria: 1) ASA physical status 4 2) Children with known or suspected co-existing neuromuscular disease, bleeding disorders, or kidney dysfunction 3) Patient shifted on ventilator to PACU

Design outcomes

Primary

MeasureTime frame
Primary Aims 1.To compare the time from the start of administration of neostigmine or sugammadex until a train-of-four (TOF) ratio of 0.9 (1st twitch paralysis) is recovered. 2.To determine the time between the start of antagonist administration (either neostigmine or sugammadex) and the recovery of a TOF ratio of 1.0. Timepoint: At 15 minutes after recovery from neuromuscular blockade

Secondary

MeasureTime frame
Secondary Aims 1. To find out the incidence of postoperative recurrence of neuromuscular blockade, which is defined either as a decrease in the TOF ratio to below 0.9 after full recovery, or as a deterioration in the clinical signs of recovery from the block. 2. To find out the incidence of other adverse effects like bradycardia, tachycardia, laryngospasm, bronchospasm and increased respiratory secretions. Timepoint: Upto 1 hour after achieving TOF ratio of 1.0

Countries

India

Contacts

Public ContactDr Aarti Agarwal

Sanjay Gandhi Post Graduate Institute of Medical Sciences

aarti_agarwal000@yahoo.co.uk9918246222

Outcome results

None listed

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