A study comparing the effectiveness of two medications for reversing muscle paralysis caused by Vecuronium

Not yet recruiting

• Conditions: Measurement and Monitoring,

• Registration Number: CTRI/2025/03/081577
• Lead Sponsor: CHRISTIAN MEDICAL COLLEGE A ND HOSPITAL

Brief Summary

Introduction: Neuromuscular blocking agents are widely used to facilitate endotracheal intubation, ease mechanical ventilation, and optimize surgical conditions. Neostigmine is a commonly used acetylcholinesterase inhibitor,which competitively antagonizes residual neuromuscular blockade by preventing metabolism of acetylcholine.Sugammadex is a gamma-cyclodextrin drug that reverses non-depolarising neuromuscular blockade, induced Vecuronium.It has been compared with acetyl-cholinesterase inhibitors, mainly Neostigmine. Sugammadex, unlike Neostigmine, does not inhibit acetylcholinesterase, hence co-administration of an antimuscarinic agent is not needed.We propose to undertake this study to compare the time taken to recover from neuromuscular blockade.

Aim and Objectives:

1.To compare the efficacy between Sugammadex and Neostigmine plus Glycopyrronium bromide for reversal of Vecuronium induced neuromuscular blockade.

2.To compare the efficacy of study drug administration to time of recovery of TOFr to 0.9

and clinical signs of recovery after tracheal extubation.

Material and Methods: This will be a double blinded and randomized controlled trial conducted on 84 patients undergoing elective surgery at Christian Medical College & Hospital, Ludhiana. The patients will be divided into two groups of 42 patients each:

Group A: Reversal with Sugammadex

Group B: Reversal with Neostigimine plus Glycopyrronium bromide.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-25
• Last Update Posted: 2025-06-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• 1.ASA (American Society of Anaesthesiologists) I and II 2.All men and women.
• 3.Adult 18-60 years.
• 4.Elective General surgeries, Orthopedic, Laproscopic, Gynecological surgeries under general anaesthesia lasting for 2-3 hours.
• 5.Planned use of neuromuscular blocking drugs.
• 6.Planned endotracheal intubation and extubation in operating room.

Exclusion Criteria

• 1.Anticipation of difficult airway.
• 2.Known or suspected neuromuscular disorder impairing neuromuscular function.
• 3.Allergy to muscle relaxants.
• 4.A personal or family history of malignant hyperthermia.
• 5.Pregnant females, breast feeding mothers, or females in childbearing age using contraceptives.
• 6.Renal impaired patients.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To compare the efficacy between Sugammadex and Neostigmine plus Glycopyrronium bromide to time of recovery of TOF ratio to 0.9.	Under minimal block, time taken for extubation is recorded at intervals of 5 mins, 10mins,15mins and so on.

Secondary Outcome Measures

Name	Time	Method
Post reversal physiological characteristics- Blood pressure, Heart rate, Spo2, Respiratory rate.	At the interval of 0mins, 10mins, 20mins, 30mins, 60mins, 120mins

Trial Locations

Locations (1)

CHRISTIAN MEDICAL COLLEGE AND HOSPITAL; 🇮🇳 Ludhiana, PUNJAB, India

CHRISTIAN MEDICAL COLLEGE AND HOSPITAL

🇮🇳Ludhiana, PUNJAB, India

DR SHEBA RATNA KUMARI KODALI

Principal investigator

7823856537

kodali.ksheeba22@yahoo.com