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CTRI Number  CTRI/2025/02/080449 [Registered on: 12/02/2025] Trial Registered Prospectively
Last Modified On: 10/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of Dexmedetomidine-Ketamine Anaesthesia and Propofol-Fentanyl Anaesthesia on Nerve Signal monitoring During Cervical spine fusion surgery in Patients with Cervical Myelopathy  
Scientific Title of Study   Effect of Dexmedetomidine-Ketamine vs. Propofol-Fentanyl Anaesthesia on Motor Evoked Potential Signal Acquisition During Cervical Lateral Mass Fusion in Patients with Cervical Myelopathy: A Randomized Controlled Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dheeraj Masapu 
Designation  Senior Consultant in NeuroAnesthesia 
Affiliation  Aster Whitefield Hospital 
Address  Department of Neuroanesthesia Block B Aster international institute of Neurosciences and Spine care Aster Whitefield Hospital Bangalore

Bangalore
KARNATAKA
560066
India 
Phone  9591964327  
Fax    
Email  dheerajmasapu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dheeraj Masapu 
Designation  Senior Consultant in NeuroAnesthesia 
Affiliation  Aster Whitefield Hospital 
Address  Department of NeuroAnesthesia Block B Aster international institute of Neurosciences and spine care Aster Whitefield Hospital Bangalore

Bangalore
KARNATAKA
560066
India 
Phone  9591964327  
Fax    
Email  dheerajmasapu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dheeraj Masapu 
Designation  Senior Consultant in NeuroAnesthesia 
Affiliation  Aster Whitefield Hospital 
Address  Department of NeuroAnesthesia Block B Aster international institute of Neurosciences and spine care Aster Whitefield Hospital Bangalore

Bangalore
KARNATAKA
560066
India 
Phone  9591964327  
Fax    
Email  dheerajmasapu@gmail.com  
 
Source of Monetary or Material Support  
Aster Intramural Research Funding 2024-2025 Aster CMI Hospital #43/2 New Airport road NH 7 Sahakara Nagar Hebbal Bengaluru Karnataka 560092 India  
 
Primary Sponsor  
Name  Aster Intramural Research Funding  
Address  Aster CMI Hospital #43/2 New Airport road NH 7 Sahakara Nagar Hebbal Bengaluru Karnataka 560092 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 
Dheeraj Masapu  Aster Whitefield Hospital Bangalore   Department of NeuroAnesthesia Block B Aster international institute of Neurosciences and spine care Aster Whitefield Hospital
Bangalore
KARNATAKA 
9591964327

dheerajmasapu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Aster CMI- Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine + Ketamine (administered via Target-Controlled Infusion (TCI) pumps)  Dexmedetomidine (administered via Target-Controlled Infusion (TCI) using the Dyck model at 0.8-1 ng/ml) in the form of Intravenous infusion till the end of surgery(4-6 Hours). Ketamine (administered at 0.5 mg/kg/hr)in the form of Intravenous infusion till the end of surgery(4-6 Hours).  
Comparator Agent  Propofol + Fentanyl (administered via Target-Controlled Infusion (TCI) pumps)  Propofol (administered via Target-Controlled Infusion (TCI) at 3.5-4 µg/kg/min) + Fentanyl (0.5 µg/kg/hr) Both will be given through Intravenous infusion till the end of surgery(4-6hrs).  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adults aged 18-65 years.
Diagnosed with cervical myelopathy (confirmed by MRI).
Scheduled for cervical lateral mass fusion with intraoperative MEP monitoring
 
 
ExclusionCriteria 
Details  Severe cardiac conditions (eg.severe coronary artery disease, heart failure).
Patients with Contraindications for MEP monitoring.
History of previous cervical spine surgery.
Inability to provide informed consent. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will focus on the MEP Amplitudes recorded from the Abductor Pollicis Brevis (APB), Tibialis Anterior (TA), Abductor Hallucis Longus (AHL), and Deltoid muscles  At multiple key points during surgery like

At Baseline after induction- T0
skin incision-T1
After Decompression-T2
After Screw Fixation-T3
End of surgery-T4 
 
Secondary Outcome  
Outcome  TimePoints 
MEP Phenotypes: Type 1-5 based on amplitude & latency
Patient Movement: Monitored to assess anesthesia effects on motor control.
Hemodynamic Stability: Heart rate & blood pressure tracked every 15 minutes.
Postoperative Pain: Measured via visual analogue scale (VAS)
6-Month Neurological Recovery: Assessed using Nurick’s grading compared to preoperative grade
Intraoperative Awareness: Evaluated using the Michigan Awareness Classification
New deficits in the postoperative period
 
MEP Phenotypes: At multiple key points during surgery like
At Baseline after induction T0
skin incision T1
After Decompression T2
After Screw Fixation T3
End of surgery T4
Patient movements - intraoperatively
Heartrate & Bloodpressure- every 15 minutes
VAS score at 0,6,12,24 ,48 hours postoperatively
Nuricks grading- preop & 6 months postop
Michigan awareness scale - on postoperative day 1
New deficits- postoperative period 24-48hours 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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   Phase 4 
Date of First Enrollment (India)   24/02/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Cervical myelopathy is a progressive condition caused by spinal cord compression, often requiring surgical intervention such as cervical lateral mass fusion. Intraoperative Motor Evoked Potential (MEP) monitoring plays a crucial role in preventing iatrogenic neurological damage during these surgeries. However, obtaining reliable baseline MEP signals remains a challenge due to the suppressive effects of anesthetic agents on motor pathways.

This Phase 4, prospective, randomized controlled trial aims to compare the efficacy of two anesthetic regimens—Dexmedetomidine-Ketamine vs. Propofol-Fentanyl—in optimizing MEP signal acquisition during cervical lateral mass fusion. The study will evaluate MEP amplitude changes, hemodynamic stability, and intraoperative patient movement as primary and secondary outcomes. Target-Controlled Infusion (TCI) pumps will be used to precisely titrate anesthetic agents, maintaining optimal conditions for neurophysiological monitoring.

A total of 76 patients with cervical myelopathy scheduled for surgery will be recruited and randomized into two groups. Intraoperative MEP signals will be recorded at predefined time points, and postoperative neurological function will be assessed using Nurick’s grading at six months.

This study aims to establish an optimal anesthetic protocol for neuromonitoring, potentially improving surgical outcomes and patient safety in cervical spine surgeries. The findings may guide future anesthetic practices in spine surgery and neurophysiology.

 
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