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A study comparing effect of two drugs (Sugammadex and Neostigmine) in reducing incidence of muscle weakness after reversal of anesthesia in patients undergoing surgery

A prospective randomized comparative study on the Effects of Sugammadex vs Neostigmine on incidence of postoperative residual neuromuscular blockade - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097988
Enrollment
130
Registered
2025-11-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K00-K95- Diseases of the digestive system Health Condition 2: H60-H95- Diseases of the ear and mastoid process Health Condition 3: N00-N99- Diseases of the genitourinary system Health Condition 4: M00-M99- Diseases of the musculoskeletal system and connective tissue Health Condition 5: C00-D49- Neoplasms

Interventions

Intervention1: SUGAMMADEX: 2mg/kg if 1-3 TOF or 4 mg/kg if extubation criteria not achieved Given as bolus dose after end of surgery to reverse neuromuscular blockade based on above mentioned dose Co

Sponsors

Rakshita Sah
Lead Sponsor
Max Smart Super Speciality Hospital Saket
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: ASA Class 1-3 Elective Non cardiac, non neurologic surgery under general anesthesia with rocuronium

Exclusion criteria

Exclusion criteria: Refusal or inability to consent. ASA IV or higher. Unstable cardiac or respiratory disease. BMI more than 30 kg per meter squared. Pregnancy or nursing. Emergency surgery or major protocol deviations. Intraoperative adverse events requiring intervention. Known neuromuscular disorders like myasthenia gravis Severe hepatic or renal failure. Allergy to study drugs History or family history of malignant hyperthermia Use of medications affecting NMB like magnesium, physostigmine

Design outcomes

Primary

MeasureTime frame
Incidence of RNMB (TOF less than 0.90) on PACU (Post anesthesia care unit) Timepoint: Baseline 1 min 2 min 3 min 4 min 5 min 10 min 15 min 20 min 25 min 30 min Optional - further every 5 min till PACU exit—

Secondary

MeasureTime frame
Time to OR Discharge ReadinessTimepoint: Administration of reversal agent to OR discharge;Post operative Pulmonary ComplicationsTimepoint: During PACU stay;Time from PACU arrival to Discharge ReadinessTimepoint: PACU arrival time PACU discharge time;Neuromuscular Recovery MetricsTimepoint: Time to achieve TOF more than 0.9 if not at extubation;Adverse Events (Bradycardia, Arrhythmias, Anaphylaxis, Hypertension, Nausea, Vomiting, Recurarisation)Timepoint: Till PACU Discharge Recurarisation will be observed for 2 hours—

Countries

India

Contacts

Public ContactDr Kamal Kumar Fotedar

Max Smart Super Speciality Hospital, Saket

kamal.fotedar@gmail.com9873003832

Outcome results

None listed

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