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CTRI Number  CTRI/2018/07/014709 [Registered on: 02/07/2018] Trial Registered Prospectively
Last Modified On: 28/06/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   a clinical trial to compare the effects of two anaesthetic drugs (propofol and dexmedetomidine) on monitoring of motor function during neurosurgery 
Scientific Title of Study   Comparison of effects of propofol and dexmedetomidine on motor evoked potentials in Neurosurgery a prospective randomised single blinded observational study  
Trial Acronym  none 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  soniya biswas 
Designation  senior resident, neuroanaesthesia 
Affiliation  Sree chitra institute for medical sciences and technology 
Address  Neuroanaesthesia division, department of anaesthesiology, Sree chitra institute for medical sciences and technology, Thiruvananthpuram

Thiruvananthapuram
KERALA
695011
India 
Phone  9336693999  
Fax    
Email  soniyabiswas2103@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Smita V 
Designation  associate professor, neuroanaesthesia 
Affiliation  Sree chitra institute for medical sciences and technology 
Address  Neuroanaesthesia division, department of anaesthesiology, Sree chitra institute for medical sciences and technology, Thiruvananthpuram

Thiruvananthapuram
KERALA
695011
India 
Phone  9336693999  
Fax    
Email  smita_vimala@yahoo.com  
 
Details of Contact Person
Public Query  
Name  soniya biswas 
Designation  senior resident, neuroanaesthesia 
Affiliation  Sree chitra institute for medical sciences and technology 
Address  Neuroanaesthesia division, department of anaesthesiology, Sree chitra institute for medical sciences and technology, Thiruvananthpuram

Thiruvananthapuram
KERALA
695011
India 
Phone  9336693999  
Fax    
Email  soniyabiswas2103@gmail.com  
 
Source of Monetary or Material Support  
sree chitra institute for medical sciences and technology, Thiruvananthpuram 
 
Primary Sponsor  
Name  Sree chitra institute for medical sciences and technology 
Address  Sree Chitra Tirunal Institute for Medical Sciences & Technology, Trivandrum Thiruvananthapuram - 695 011, Kerala, India.  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Soniya Biswas   sree chitra institute for medical sciences and technology  neurosurgery operation theatre, 4th floor, C block
Thiruvananthapuram
KERALA 		 9336693999

soniyabiswas2103@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee, Sree Chitra Tirunal Institute for Medical ciences and Technology, Thiruvananthpuram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  – Any patient posted for neurosurgery who requires motor evoked potential monitoring intraoperatively,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  D group  dexmedetomidine loading dose at a rate of 0.5μg/kg over 10 minutes followed by infusion at a rate of 0.2 – 0.7 μg/kg/hr intravenously for entire duration of surgery 
Comparator Agent  P group  P group - propofol at a rate of 75- 100 μg/kg/min intravenous for the surgical duration  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. patient presenting for any spinal or intracranial surgery for a lesion involving motor cortex or pyramidal tract requiring intraoperative MEP monitoring
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Amplitude of motor evoked potential (decrease of 50% or more from baseline)
Latency of motor evoked potential (increase of 10% or more from baseline)
 		 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 – 10 minutes after T3
T5, T6 – recorded during the procedure
Tx – any other time if surgery requires it
Te – at the end of surgery
 
 
Secondary Outcome  
Outcome  TimePoints 
heart rate, mean blood pressure trend (hemodynamic stability )
Amount of anaesthetic agents (amount of propofol and dexmedetomidine required)
Complications – 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
 		 Throghout the intraoperative period.
 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is a prospective randomised single blinded observational study to compare the effects of propofol and dexmedetomidine on motor evoked potentials monitoring in neurosurgery that will be conducted in SCTIMST, Thiruvananthpuram. The primary outcome measures will be to compare the effects of the two drugs on amplitude and latency of motor evoked potentials. The secondary outcome measures will be to compare the hemodynamic s, time to recovery and complications between the two anaesthetic regimens when used for monitoring motor evoked potentials during neurosurgery. 
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