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Comparing Two Methods to Wake Patients Faster After Lumbar Spine Surgery

A Comparative Evaluation of Half Dose Sugammadex (2mg/kg) Combined with Neostigmine to full Dose Sugammadex (4mg/kg) for Reversal of Deep Neuromuscular Blockade in Elective Lumbar Spinal Surgery: A Randomised Double-Blind Study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/101372
Enrollment
102
Registered
2026-01-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: M968- Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified

Interventions

Intervention1: Inj Sugammadex and Inj Neostigmine versus Inj Sugammadex: Inj Sugammadex (2ml/kg) with Inj Neostigmine (0.05mg/kg) versus Inj Sugammadex (4mg/kg) Control Intervention1: Inj Sugammadex:

Sponsors

Department of Anaesthesiology RNT medical college and MB Government Hospital Udaipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status grade I,II,III Patient Scheduled for elective spine surgery under general anaesthesia

Exclusion criteria

Exclusion criteria: Patient refusal Patient with any neuromuscular disorder or renal dysfunction History of malignant hyperthermia History of general anaesthesia exposure in the 7 days preceding the surgery History of known allergy to any drugs used in the study Pregnant and lactating mothers

Design outcomes

Primary

MeasureTime frame
To compare time from reversal administration to 90% of recovery of TOF ratio after vecuronium induced deep neuromuscular blockade (time of extubation)Timepoint: Upto 10 minutes

Secondary

MeasureTime frame
1. Time to spontaneous breathing 2. Time to respond to verbal commands 3. Haemodynamic changes after reversal 4. Total duration of anaesthesia & surgery 5. Residual paralysis 6. Side effects/complications, if any Timepoint: It will be measured at these intervals, baseline (before study drug is given), at 0 min (after study drug is given), at 1 min, at 2 min, at 3 min, at 4 min, at 5 min, at 6min, at 7min, at 8min, at 9 min, at 10 min, at 15min, at 20 min, at 25 min, at 30 min

Countries

India

Contacts

Public ContactDr. Usha Rani

RNT Medical College

devendraabaes@yahoo.in9829623028

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026