| 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
|
|
|
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
|
|
|
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
|
|