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To study the effect of a drug, dexmedetomidine, on nerve monitoring during surgery of spine

Effect of Dexmedetomidine administration on Intraoperative Monitoring of Evoked Potentials in Paediatric Scoliosis Surgery A Single Centre Double Blinded Prospective Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025453
Enrollment
50
Registered
2020-05-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: M411- Juvenile and adolescent idiopathicscoliosis

Interventions

Intervention1: Intravenous dexmedetomidine loading dose at 1 mcg/kg: Dose - 1 mcg/kg Frequency - No repeat dose Duration - Drug will be administered over 10 minutes. Route of administration - intraven

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with idiopathic dorsolumbar scoliosis Belonging to American Society of Anesthesiology Physical Status 1 and 2

Exclusion criteria

Exclusion criteria: Patient/parental refusal Pre existing motor neurological deficit of lower limbs with motor power less than 4 as per medical research council grading system

Design outcomes

Primary

MeasureTime frame
To determine the percentage change in amplitude of Trans-cranial motor evoked potentials (TcMEPs) , following 2 different intravenous loading doses of dexmedetomidine (0.5 mcg/kg and 1 mcg/kg) in adolescents undergoing deformity correction for idiopathic scoliosisTimepoint: Baseline prior loading dose Following loading dose at 0 minutes, 10 minutes, 20 minutes and 30 minutes—

Secondary

MeasureTime frame
To determine the change in latency and amplitude of somatosensory evoked potentials and peripheral motor evoked potentialsTimepoint: Throughout duration of study;To determine the difference in blood pressure and heart rateTimepoint: Baseline prior loading dose Following loading dose at 0 minutes, 10 minutes, 20 minutes and 30 minutes;To determine the difference in propofol infusion rates to adjust BIS to 40 â?? 50Timepoint: Throughout duration of study;To determine the difference in TcMEPs in different muscle groupsTimepoint: Baseline prior loading dose Following loading dose at 0 minutes, 10 minutes, 20 minutes and 30 minutes;To determine the requirement of treatment for changes in blood pressure and heart rateTimepoint: Throughout duration of study—

Countries

India

Contacts

Public ContactKarthik Vasudevan Iyer

All India Institute of Medical Sciences New Delhi

drkarthikviyer@gmail.com9810667520

Outcome results

None listed

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