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
|
|
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
|
|
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. |