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

Not Applicable

Conditions: Health Condition 1: null- â?? Any patient posted for neurosurgery who requires motor evoked potential monitoring intraoperatively

Registration Number: CTRI/2018/07/014709

Lead Sponsor: Sree chitra institute for medical sciences and technology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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 <3

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 < 50 bpm (beats per minute), presence of heart block

15. Antihypertensive medication with alpha methyl dopa, clonidine

16. Patient on beta blockers

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
heart rate, mean blood pressure trend (hemodynamic stability ) <br/ ><br>Amount of anaesthetic agents (amount of propofol and dexmedetomidine required) <br/ ><br>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. <br/ ><br> <br/ ><br>Time of recovery <br/ ><br>Timepoint: Throghout the intraoperative period. <br/ ><br>