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CTRI Number  CTRI/2022/12/048497 [Registered on: 26/12/2022] Trial Registered Prospectively
Last Modified On: 22/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison between Dexmedetomidine and fentanyl on intraoperative neuromuscular monitoring using propofol based total intravenous anesthesia regimen in spine surgeries. 
Scientific Title of Study   Dexmedetomidine versus fentanyl in intraoperative neuromuscular monitoring using propofol based total intravenous anesthesia regimen in spine surgeries. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Medha Bhardwaj 
Designation  DM resident 
Affiliation  Mahatma Gandhi hospital 
Address  Department of neuroanaesthesiology, Mahatma Gandhi university of medical sciences and technology, RIICO institutional area, Sitapura, Tonk road, Jaipur - 302022
Department of neuroanaesthesiology, Mahatma Gandhi university of medical sciences and technology, RIICO institutional area, Sitapura, Tonk road, Jaipur - 302022
Jaipur
RAJASTHAN
302022
India 
Phone  998890238  
Fax    
Email  bhardwajmedha14@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sunita Sharma 
Designation  Associate professor  
Affiliation  Mahatma Gandhi hospital 
Address  Department of neuroanaesthesiology, Mahatma Gandhi medical college and hospital, Sitapura jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  998890238  
Fax    
Email  drsunitakhs@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Medha Bhardwaj 
Designation  DM resident 
Affiliation  Mahatma Gandhi hospital 
Address  B-108 okay plus venus appartment, near jeevan rekha hospital
B-108 okay plus venus appartment, near jeevan rekha hospital
Jaipur
RAJASTHAN
302017
India 
Phone  998890238  
Fax    
Email  bhardwajmedha14@gmail.com  
 
Source of Monetary or Material Support  
Mahatama Gandhi Medical College and Hospital jaipur rajasthan 
 
Primary Sponsor  
Name  Mahatma Gandhi medical college and hospital  
Address  MGMCH Sitrapura Jaipur 302022 Rajasthan 
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 
medha bhardwaj  Mahatama Gandhi Medical College And Hospital  Mahatama Gandhi Medical College And Hospital Sitapura Jaipur 302022 Rajasthan India Jaipur RAJASTHAN
Jaipur
RAJASTHAN 
9988900238

bhardwajmedha14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: G328||Other specified degenerative disorders of nervous system in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  intravenous propofol (5– 10 mg/kg/h) and dexmedetomidine (0.5–0.7 mcg/kg/h) in group D   intravenous propofol (5– 10 mg/kg/h) and dexmedetomidine (0.5–0.7 mcg/kg/h) in group D started at the time of induction throughout the surgery 
Comparator Agent  intravenous propofol (5–10 mg/kg/h) and fentanyl (0.01–0.03 mg/kg/h) in group F  intravenous propofol (5–10 mg/kg/h) and fentanyl (0.01–0.03 mg/kg/h) in group F started after the induction of anesthesia till the end of surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.ASA physical status I, II
2.Aged 18-65 years scheduled for major spine surgeries
3.Both male and female

 
 
ExclusionCriteria 
Details  1.Patient refusal
2.History of allergy to the study drug
3.Impaired renal/hepatic function
4.History of allergy to study drug
5.Severe cardiovascular disease
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the effect of dexmedetomidine and fentanyl on intraoperative hemodynamic parameters and their interference with MEP.  BASELINE,INTUBATION 5 MINS,10 MINS, 20 MINS,30 MINS,60 MINS,120 MINS,150MINS,180 MINS,210 MINS,240 MINS,270 MINS,300 MINS,330 MINS,360 MINS

 
 
Secondary Outcome  
Outcome  TimePoints 
• To assess the quality of surgical field.   feedback from surgeon at the end of surgery 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   26/12/2022 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

The integrity of the spinal cord is potentially at risk during spine surgeries. Intraoperative neurophysiological monitoring has been the standard of care and is considered mandatory in order to reduce the risk of damage to the neural pathways during such procedures. (1) Continuous use of evoked potentials in the intraoperative period helps to prevent and reduce the incidence of neural injury.

The main goal has been to improve the assessment of different components of the motor system and to enhance both the sensitivity and specificity of MEP findings. Reliable interpretation of myogenic potentials elicited by transcranial electric or magnetoelectric stimulation of the motor cortex and recorded from extremity muscles is compromised, however, by a number of factors, mainly by the influence of general anesthesia.

Fentanyl is a synthetic opioid of the phenylpiperidine family and is structurally related to meperidine. It is highly potent with a rapid onset and a shorter duration of action. The intraoperative requirement of propofol for hypnosis is also reduced by the use of fentanyl.

Dexmedetomidine is an alpha 2 agonist with beneficial actions such as sedation, analgesia, and anxiolysis exerting an opioid-sparing effect which in turn reduces the minimum alveolar concentration (MAC) of inhaled anesthetics. It elicits a strong sedative effect without any evident respiratory depression and is administered as an anesthetic adjuvant. (2)It is a potentially useful drug in the TIVA regimen, facilitating neurophysiological monitoring as it does not interfere with SSEP recordings. Dexmedetomidine as an adjuvant in propofol-based TIVA has been suggested to alleviate postoperative pain also. (3)

 In our study we used propofol-based total intravenous anesthesia (TIVA) with either dexmedetomidine or fentanyl as adjuvants to minimize the use of inhalational agents which are known to interfere with neurophysiological monitoring.

 
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