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a clinical trial to compare the effects of two anaesthetic drugs (propofol and dexmedetomidine) on monitoring of motor function during neurosurgery

Comparison of effects of propofol and dexmedetomidine on motor evoked potentials in Neurosurgery a prospective randomised single blinded observational study - none

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/07/014709
Enrollment
70
Registered
2018-07-02
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: null- â?? Any patient posted for neurosurgery who requires motor evoked potential monitoring intraoperatively

Interventions

Control Intervention1: P group: P group - propofol at a rate of 75- 100 μg/kg/min intravenous for the surgical duration Control Intervention2: D group: dexmedetomidine loading dose at a rate of 0.5

Sponsors

Sree chitra institute for medical sciences and technology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. patient presenting for any spinal or intracranial surgery for a lesion involving motor cortex or pyramidal tract requiring intraoperative MEP monitoring

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. Age less than 18 years and more than 60 years. 3. Autonomic instability 4. Long standing Diabetes mellitus ( > 10 years) 5. Pregnant & nursing mothers 6. Motor power grade 7. Neuromuscular disease 8. Cardiopulmonary disease 9. skull defects at the region where electrodes need to be placed 10. intracranial apparatus (electrodes, vascular clips, and shunts), cardiac pacemakers, or other implanted pumps 11. renal and hepatic disease 12. history of chronic alcohol use 13. allergy to any of the anaesthetic agents used in the study 14. Preoperative heart rate 15. Antihypertensive medication with alpha methyl dopa, clonidine 16. Patient on beta blockers

Design outcomes

Primary

MeasureTime frame
Amplitude of motor evoked potential (decrease of 50% or more from baseline) Latency of motor evoked potential (increase of 10% or more from baseline) Timepoint: T1 - baseline value of MEP obtained when the T4/T1 reaches 0.9, and before dividing the patients to two groups T2 - 10 min after T1 when the dexmedetomidine loading dose infusion would have just finished in D group. T3- 10 minutes after T2 T4 â?? 10 minutes after T3 T5, T6 â?? recorded during the procedure Tx â?? any other time if surgery requires it Te â?? at the end of surgery

Secondary

MeasureTime frame
heart rate, mean blood pressure trend (hemodynamic stability ) Amount of anaesthetic agents (amount of propofol and dexmedetomidine required) Complications â?? Bradycardia (heart rate 50 bpm), Hypotension or hypertension (decrease or increase in blood pressure 20% from baseline), frequency of complications like unwanted limb movement or respiratory efforts, injury at the insertion site of electrodes and tongue laceration. Time of recovery Timepoint: Throghout the intraoperative period.

Countries

India

Contacts

Public Contactsoniya biswas

Sree chitra institute for medical sciences and technology

smita_vimala@yahoo.com9336693999

Outcome results

None listed

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