A clinical study to compare two ways of giving the medicine Sugammadex — a fixed dose of 200 mg and a weight-based dose of 4 mg per kilogram — to see which works better and is safer for reversing muscle relaxation after general anesthesia in adult patients undergoing planned surgery.

Comparative Efficacy and Safety of Fixed-Dose of 200 mg Versus Weight-Based 4 mg/kg Sugammadex for Reversal of Deep Neuromuscular Blockade in Adult Patients Undergoing Elective Surgery— A Randomized, controlled trial” - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096381

Enrollment

Registered

2025-10-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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: intravenous injection of sugammadex: the study drug will be given intravenously for the effect. Control Intervention1: two different doses of Sugammadex: This study will be comparing tw

Eligibility

Inclusion criteria

Inclusion criteria: Age 18 to 75 years. ASA physical status I to III. Elective surgical procedure under general anaesthesia with planned use of continuous infusion/boluses of vecuronium resulting in deep block at end of procedure. Intraoperative confirmation of deep block at time of reversal attempt(TOF count = 0 with 1 to 2 posttetanic counts PTC). Ability to provide written informed consent.

Exclusion criteria

Exclusion criteria: age less tha 18 years and more than 75 years pregnant and lactating females liver and renal failure obese patients neuromuscular disorder

Design outcomes

Primary

Measure	Time frame
Time in seconds from completion of study drug injection to first documented time of recovery of TOF Ratio of more than 0.80 and 0.90 at adductor pollicis measured by quantitative neuromuscular monitor. Timepoint: Time in seconds from completion of study drug injection to first documented time of recovery of TOF Ratio of more than 0.80 and 0.90 at adductor pollicis measured by quantitative neuromuscular monitor.	—

Measure

Time frame

Time in seconds from completion of study drug injection to first documented time of recovery of TOF Ratio of more than 0.80 and 0.90 at adductor pollicis measured by quantitative neuromuscular monitor. Timepoint: Time in seconds from completion of study drug injection to first documented time of recovery of TOF Ratio of more than 0.80 and 0.90 at adductor pollicis measured by quantitative neuromuscular monitor.

—

Secondary

Measure	Time frame
Proportion of patients achieving TOFR more than 0.90 within 3 min and within 3 to 5 min. Timepoint: 3 and 3 to 5 minutes;Adverse events like allergic reactions, bradycardia , hypotension, arrhythmias, anaphylaxis, residual blockade. Timepoint: no;Cost analysis by calculating number of 200mg vials used per patient and estimated drug cost difference. Timepoint: no	—

Countries

India

Contacts

Public ContactDR ABHA SINGH

United institute of medical sciences Prayagraj

drabhasingh1990@yahoo.in9956742300

Outcome results

None listed

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