Comparing the Effectiveness of Two different Reversal Agents in Reversing the Neuromuscular Paralysis by Muscle Relaxant in patients undergoing surgery under General anesthesia

Comparative Efficacy Of Sugammadex Versus Neostigmine in Reversal Of Vecuronium Induced Moderate Neuromuscular Blockade in patients undergoing surgery under General anesthesia in a tertiary care hospital - A double blinded randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070359

Enrollment

Registered

2024-07-10

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

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: Sugammadex: 2 mg/kg dose by intravenous route as a bolus over 10sec duration after the appearance of T2 count in Train of Four count at the end of surgery Control Intervention1: Neostig

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients aged between 18 to 60yrs, Patients belonging to ASA class I and II

Exclusion criteria

Exclusion criteria: 1) Significant kidney disease (stage 4 kidney disease or higher), Significant liver disease (aspartate aminotransferase [AST] or alanine aminotransferase[ALT] more than twice the upper limit of normal), Emergency surgeries under general anaesthesia, Patients requiring post operative mechanical ventilation, Difficult airway, Pregnancy/Breastfeeding, Known case of neuromuscular disorder, Allergies to study drugs

Design outcomes

Primary

Measure	Time frame
To compare the incidence of post operative residual neuromuscular paralysis with sugammadex or neostigmine during vecuronium induced moderate neuromuscular blockade with Train of Four (TOF) monitoring in patients undergoing surgery under general anesthesiaTimepoint: 1 year	—

Secondary

Measure	Time frame
To compare the baseline Forced expiratory volume (FEV1) and Peak expiratory flow rate (PEFR) values and post-operative Forced expiratory volume (FEV1) and Peak expiratory flow rate (PEFR) after arrival to Post anaesthesia care unit (PACU)Timepoint: 1 year;To compare the time from the start of administration of sugammadex or neostigmine to recovery of the Train of Four (TOF) ratio to 0.9Timepoint: 1 year;To record adverse events in both the groups until discharge from Post anaesthesia care unit (PACU)Timepoint: 1 year	—

Measure

Time frame

To compare the baseline Forced expiratory volume (FEV1) and Peak expiratory flow rate (PEFR) values and post-operative Forced expiratory volume (FEV1) and Peak expiratory flow rate (PEFR) after arrival to Post anaesthesia care unit (PACU)Timepoint: 1 year;To compare the time from the start of administration of sugammadex or neostigmine to recovery of the Train of Four (TOF) ratio to 0.9Timepoint: 1 year;To record adverse events in both the groups until discharge from Post anaesthesia care unit (PACU)Timepoint: 1 year

—

Countries

India

Contacts

Public ContactK PRIYANGA

Pondicherry Institute of Medical Sciences

priyapriyanga94@gmail.com8778365041

Outcome results

None listed

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