| CTRI Number |
CTRI/2024/05/067977 [Registered on: 28/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| 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
|
Study comparing the intravenous Lignocaine and Dexmedetomidine infusions as anaesthesia adjuvant for spine surgerys with regards to monitoring of the spinal cord function in neuromonitoring cases |
|
Scientific Title of Study
|
Comparing the effect of lignocaine infusion on motor evoke potential (MEP) with dexmedetomidine infusion in intraoperative neuromonitoring cases |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Eldo Issac |
| Designation |
Assistant Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia,
Amrita Institute of Medical Sciences,A block,6TH tower, 1st floor,Ponekkara,ernakulam
Ernakulam
KERALA
682041
India |
| Phone |
04872856162 |
| Fax |
|
| Email |
eldopen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sundaram M |
| Designation |
Post Graduate |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia
Amrita Institute of Medical Sciences
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
04872856162 |
| Fax |
|
| Email |
sundarambalaji143@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Eldo Issac |
| Designation |
Assistant Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia, A Block, 6th Tower 1st Floor,
Amrita Institute of Medical Sciences, Ponekkara P.O
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
04872856162 |
| Fax |
|
| Email |
eldopen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of medical sciences kochi,Ernakulam
KERALA
682041
India |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of medical sciences |
| Address |
Amrita Institute of Medical Sciences, Department of Anaesthesia, A Block, 6th Tower 1st Floor, Ponekkara P.O, Ernakulam,Kerala, India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Eldo Issac |
Amrita Institute of medical sciences |
Depaertment of Anaesthesia, A Block, 6th Tower 1st Floor Ponekkara P.O Ernakuulam, Kerala
Ernakulam
KERALA |
9495012969
04842802020
eldopen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Amrita School of Medicine |
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 |
| Comparator Agent |
The effect of Dexmediotomidine on motor evoke potential in neuromuclar monitoring |
Dexmeditomidine is a common drug used in neuromuscular monitoring for MEP in spine cases along with sevoflurane . It is more sedative and cause delay awakening in patients.The infusion will starts intravenously at a dose of 0.5mcg/kg/hr infusion immediately after induction of anesthesia and will continue through out the surgery till the intraoperative neuromonitoring stops. The MEP will be measured in specific intervals at 30 minutes, after positioning to prone and after 30 minutes and 1 hour during surgery. Along with MEP, the intraoperative utilization of opioid (fentanyl) is also assessed.The hemodynamic effects of the infusion is also measured during the monitoring |
| Intervention |
The effect of lignocaine infusion on motor evoke potential in spine cases |
Lignocaine has been used as an adjuvant to inhalational anesthesia to measure the motor evoke potential in spine cases. The infusion will starts immediately after induction of anesthesia and will continue through out the surgery till the intraoperative neuromonitoring stopps. The MEP will be measured in specific intervals during surgery. Along with MEP, the intraoperative utilization of opioid (fentanyl) is also assessed.The hemodynamic effects of the infusion is also measured during the monitoring |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for spine surgery with normal motor power Grade of 5. Patients with ASA grade 1,2,3 |
|
| ExclusionCriteria |
| Details |
Any patients with an allergy to lignocaine.Any patient for emergency surgery. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Compare the Lignocaine infusion and Dexmedetomidine infusion on Motor evoked potential during intraoperative neuromonitoringÂ
|
The measurement of motor evoke potential  after 30 minutes initial bolus of infusion. Then subsequent measurement immediately after positioning prone and 30 minutes and one hour of surgery, The time interval between the stoppage of the infusion and patient response to call also will ne taken |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dose of intraoperative fentanyl,hemodynamic variables,awakening time from end of infusion. |
dose of fentanyl and isoflurane at end of surgery haemodynamic variables 3,5 minutes after bolus and after positioning then every 30 minutes.Time taken to awake after infusion |
|
|
Target Sample Size
|
Total Sample Size="164"
Sample Size from India="164"
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)
|
02/07/2024 |
| 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="0"
Months="6"
Days="25" |
|
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
|
This is a randomized observational study conducted in 168 patients undergoing surgery under general anesthesia. There will be 2 groups of patients. One group of patients will be those who are receiving dexmediotmidine as an adjuvant to general anesthesia. Other group consists of patients receiving lignocaine as an adjuvant.Both group receive general anesthesia as per standard protocol. The patients motor evoke potential will be noted after 30 minutes, after positioning the patient prone and 30 minutes and 1 hour.Hemodynamic variables will be noted along the same time. At the endo surgery intraoperative fenatnyl consumption is noted. The time interval between the ending of infusion and the response of the patient to call by eye opening will bw also recorded .The date from both will be be compared. |