To compare the time taken for reversal of neuromuscular blockade in patients undergoing general anaesthesia with either sugammadex or sugammadex in combination with neostigmine

Comparison of sugammadex and sugammadex combined with neostigmine for reversal of vecuronium induced neuromuscular blockade in patients undergoing general anaesthesia : A randomised clinical trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/083118

Enrollment

120

Registered

2025-03-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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: Group A will receive sugammadex at a dose of 2 mg/kg through intravenous route of administration as a single bolus dose at the end of the surgery for reversal of vecuronium

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 60 years of either gender – male or female. 2. Patients with American Society of Anaesthesiologists (ASA) physical status Grade I to Grade II.

Exclusion criteria

Exclusion criteria: 1. Patient’s refusal. 2. Patients with suspected difficult airway. 3. Patients with body mass index (BMI) more than 30 kg/m2. 4. Patients with known allergy to sugammadex, neostigmine and vecuronium. 5. Patients with pre-existent clinical conditions like chronic obstructive pulmonary disease, severe renal dysfunction, hepatic disease, cardiovascular disease, neurodegenerative disease and neuromuscular disease. 6. Pregnant or breastfeeding patients.

Design outcomes

Primary

Measure	Time frame
The time (in minutes) taken from the start of administration of the study drug (sugammadex or sugammadex combined with neostigmine) to the appearance of second twitch of train of four stimulation till recovery of normalised TOF ratio of 0.9 or more.Timepoint: Outcome will be measured in a single time point, i.e. from the point of administration of study drug (baseline),till attainment of train of four ratio of 0.9 .	—

Measure

Time frame

The time (in minutes) taken from the start of administration of the study drug (sugammadex or sugammadex combined with neostigmine) to the appearance of second twitch of train of four stimulation till recovery of normalised TOF ratio of 0.9 or more.Timepoint: Outcome will be measured in a single time point, i.e. from the point of administration of study drug (baseline),till attainment of train of four ratio of 0.9 .

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Secondary

Measure	Time frame
Hemodynamic parameters like Blood pressure, pulse rate, spo2, heart rate & also any adverse effects like bradycardia, tachycardia, hypotension, anaphylaxis, nausea or vomiting. Timepoint: Secondary outcomes will be measured from baseline that is at the time of administration of study drug. After that,it will be measured every 10 minutes thereafter till immediate postoperative period for upto 1 hour.	—

Measure

Time frame

Hemodynamic parameters like Blood pressure, pulse rate, spo2, heart rate & also any adverse effects like bradycardia, tachycardia, hypotension, anaphylaxis, nausea or vomiting. Timepoint: Secondary outcomes will be measured from baseline that is at the time of administration of study drug. After that,it will be measured every 10 minutes thereafter till immediate postoperative period for upto 1 hour.

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Countries

India

Contacts

Public ContactY Arunkumar Singh

Regional Institute of Medical Sciences, Imphal, Manipur

yaks48@yahoo.com9862282518

Outcome results

None listed

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