Effect of Sugammadex drug in spine surgeries measuring motor evoked potential in age group of 18-60 years

Effect of sugammadex on Transcranial electrical motor evoked potential TceMEP in thoracolumbar spine surgeries using rocuronium based neuromuscular blockade A randomised clinical trial - nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072814

Enrollment

Registered

2024-08-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Health Condition 1: G55- Nerve root and plexus compressionsin diseases classified elsewhere

Interventions

Intervention1: Administration of sugammadex: Drug given 2 mins prior to dural puncture in thoracolumbar spine surgeries Intervention2: sugammadex drug: sugammadex is a muscle relaxant which will be gi

Eligibility

Inclusion criteria

Inclusion criteria: Adult ASA I and II patients with thoracic and lumbar lesions who will be scheduled for spine surgery under general anesthesia and intraoperative neurophysiological monitoring.

Exclusion criteria

Exclusion criteria: 1. Patient refusal for consent. 2. Patient with H/O allergy to test drugs. 3. History of epilepsy or use of antiepileptic drugs. 4. TceMEP stimulating or recording site infection. 5. Use of inhalation anesthesia during the surgery. 6. Prior history of chronic heart failure/Renal failure /Sepsis/Respiratory failure.

Design outcomes

Primary

Measure	Time frame
To compare the mean TceMEP amplitudes in the abductor pollicis brevis muscles of the upper extremities 5 minutes after dural opening.Timepoint: 5 mins after dural opening.	—

Secondary

Measure	Time frame
To compare the TceMEP amplitudes recorded at 5, 10, 20, 30, and 60minutes after dural opening in the abductor pollicis brevis and Adductor hallusis longus and tibialis anterior. • TceMEP latency and TOF at all time points as above. • Incidence of body movement classified as either nociception-induced movement or excessive field movement (defined as grossly visible movement as determined by the surgical and anesthesia teams). • Motor function assessment using the “sensory-motor profile awake scale ? (SMP-a) 5days after surgery.Timepoint: 5 mins , 10 mins , 20 mins, 30 mins , 60 mins after dural opening.	—

Measure

Time frame

To compare the TceMEP amplitudes recorded at 5, 10, 20, 30, and 60minutes after dural opening in the abductor pollicis brevis and Adductor hallusis longus and tibialis anterior. • TceMEP latency and TOF at all time points as above. • Incidence of body movement classified as either nociception-induced movement or excessive field movement (defined as grossly visible movement as determined by the surgical and anesthesia teams). • Motor function assessment using the “sensory-motor profile awake scale ? (SMP-a) 5days after surgery.Timepoint: 5 mins , 10 mins , 20 mins, 30 mins , 60 mins after dural opening.

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Countries

India

Contacts

Public ContactDr Shiv Lal Soni

Pgimer Chandigarh

dr.shivsoni@gmail.com9914208550

Outcome results

None listed

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