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Comparison of Sugammadex and Neostigmine to change the effect of Rocuronium in adult patients undergoing neurosurgery

Comparison of Sugammadex vs. Neostigmine for reversal of Rocuronium induced neuromuscular blockade in adult patients undergoing elective neurosurgery - SUNNE

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064138
Enrollment
62
Registered
2024-03-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhere

Interventions

Intervention1: Sugammadex: Drug Inj Sugammadex 2mg/kg will be given once over 15-30 seconds for reversal of rocuronium induced neuromuscular blockade in adult neurosurgical patients Control Interven

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA grade 1&2 patients, aged 18-65 yrs scheduled for elective neurosurgery and planned for extubation immediately following surgery will be included for the study.

Exclusion criteria

Exclusion criteria: The following patients will be excluded from the study: 1. Refusal of consent. 2. Patients with Glasgow Coma Scale (GCS) 3. Patients having psychotic disorders 4. Pregnant patients 5. Patients intended for postoperative mechanical ventilation or not extubated after surgery 6. Known or suspected allergy to study drugs 7. Patients with uncontrolled hypertension, uncontrolled D.M or heart disease 8. Patient with history of late recovery from anaesthesia previously

Design outcomes

Primary

MeasureTime frame
time taken from the point of administration of reversal to extubationTimepoint: After surgery,the time point of administration of reversal is taken as 0 minutes.From 0 minutes till extubation the time duration will be noted.

Secondary

MeasureTime frame
Systolic arterial pressure, diastolic arterial pressure, mean arterial pressure (MAP), heart rate (HR), oxygen saturation(SpO2), temperature, end tidal carbon dioxide (EtCO2), bispectral index(BIS), TOF count and TOF ratio and PTCTimepoint: baseline, induction, intubation, 10 minutes after intubation, incision, closure, stopping of fentanyl, rocuronium, stopping of propofol/inhalational, during reversal administration, at extubation, 1 min after, 2 min after, 5 minutes after and 10 minutes after extubation

Countries

India

Contacts

Public ContactDr Suman Sokhal

AIIMS

sumansokhal82@gmail.com011-26594420

Outcome results

None listed

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