| CTRI Number |
CTRI/2024/05/067564 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparison of intravenous anaesthesia with gas based anaesthetic with respect to reliability of monitoring of spinal cord function during spine surgery. |
|
Scientific Title of Study
|
Comparison of TIVA with Propofol versus Sevoflurane and Dexmedetomidine on reliability of intra-operative MEP monitoring in spine surgical patients having pre-operative paresis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mathew George |
| Designation |
Associate Professor and Senior Consultant |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Amrita Institute of Medical Sciences
Amrita hospital
Ponekkara Road, P.O, Edapally
Kochi, Ernakulam
Kerala-682041
Ernakulam
KERALA
682041
India |
| Phone |
9447841795 |
| Fax |
|
| Email |
mathew.doc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mathew George |
| Designation |
Associate Professor and Senior Consultant |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Division of Orthiopaedic and Neuroanaesthesia,
Department of Anaesthesia,
Amrita Institute of Medical Sciences
Amrita hospital
Ponekkara Road, P.O, Edapally
Kochi, Ernakulam
Kerala-682041
Ernakulam
KERALA
682041
India |
| Phone |
9447841795 |
| Fax |
|
| Email |
mathew.doc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shyama C Shyam Sunder |
| Designation |
Post-Graduate Resident |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia, Amrita Institute of Medical Sciences
Amrita hospital
Ponekkara Road, P.O, Edapally
Kochi, Ernakulam
Kerala-682041
Ernakulam
KERALA
682041
India |
| Phone |
9566094316 |
| Fax |
|
| Email |
shyamasmail@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Mathew George |
| Address |
Associate professor-Anaesthesia
Amrita Institute of Medical Sciences
Amrita hospital
Ponekkara road P.O, Edappally
Kochi, Ernakulam
Kerala-682041 |
| Type of Sponsor |
Other [self] |
|
|
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 Mathew George |
Amrita Institute of Medical Sciences |
3-1 Operation theatres,
Orthiopaedic and Neurosurgical Departments,
Amrita Institute of Medical Sciences and Research Centre,
Ponekkara Road P.O
Edapally, Kochi
Ernakulam
682041
Ernakulam
KERALA |
9447841795
mathew.doc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee-Amrita Institute of Medical Sciences |
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 |
Using Dexmedetomidine-Sevoflurane combination anaesthetic during spine surgeries |
Patient will be given anaesthesia with Dexmedetomidine-Sevoflurane. During critical junctures of surgery, spinal cord integrity will be assessed by motor evoked potential monitoring, and the values of the potentials will be recorded, and any muscles where potential is unrecordable will be noted. Study begins with induction of anaesthesia and will conclude with the patient recovering from the anaesthetic and neurological status is confirmed postoperatively. |
| Intervention |
Using Total Intravenous Anaesthesia with Propofol during spine surgeries |
Patient will be given anaesthesia with Propofol based TIVA. During critical junctures of surgery, spinal cord integrity will be assessed by motor evoked potential monitoring, and the values of the potentials will be recorded, and any muscles where potential is unrecordable will be noted. Study begins with the induction of anaesthesia and will conclude with the patient recovering from the anaesthetic and neurological status is confirmed postoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for spine surgeries who have pre-operative motor power of Grade 3-4 attributable to the surgical issue that is being addressed |
|
| ExclusionCriteria |
| Details |
Patients with extensive flaccid paralysis below the level of surgery.
Patients with known hypersensitivity to any of the drugs included in the protocol. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome is based on the intra-operative reliability of measured potentials calculated on basis of ratio of the number of muscles with reliable potentials to the number of muscles monitored.
|
Measurements will be taken 30 minutes after the induction of anaesthesia and during critical junctures of surgery. Study ends after recovery from anaesthesia and neurological assessment is completed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare intra-operative reliability of motor evoked potentials with respect to incidence of fresh post-op neurological deficits |
Post-operative assessment of fresh neurological deficits will be done after reversal of anaesthesia & patient has awoken. Following neurological assessment the secondary outcome will also have been completed |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
01/06/2024 |
| 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="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
|
Patients are allocated the study group based on a computer generated random number sequence. Patients in Group D will receive dexmedetomidine and inhaled sevoflurane for anaesthetic maintenance, while group P will receive Propofolinfusion for maintenance of anaesthesia.
The patients will be maintained NPO (nil per orally) for 6 hours (solids) and 2 hours (clear fluids) prior to surgery. On reaching the operating room, patients in Group D will be induced with fentanyl 2 μg.kg-1, a sleep dose of propofol intravenously and muscle relaxation achieved with atracurium 0.5 mg.kg-1. Patients in group P will receive fentanyl 2 μg.kg-1, propofol to achieve plasma level of 3 μg.ml-1 and atracurium 0.5 mg.kg-1. The patient will be intubated and positive pressure ventilation maintained with oxygen-air mixture at a fresh gas floe of 1 litre per minute in a closed circuit to maintain normocapnia. Fentanyl infusion will be initiated for all patients at a dose of 1μg.kg-1.hour-1, which may be increased up to 3 μg.kg-1.hour-1 based on the managing anaesthetist’s judgement of the patients’ analgesic requirements.Vitals monitoring will include invasive blood pressure, electrocardiogram, heart rate, oropharyngeal temperature, urine output and end tidal carbon dioxide concentration in all the patients. Use of a forced air warmer and maintaining the room temperature at 20°C, will aid in reducing the extent of patient hypothermia. All patients will have a BIS electrode placed for assessment of anaesthetic depth and to facilitate titration of anaesthetics.
Patientsin group D will receive a dexmedetomidine bolus of 0.5 μg.kg-1over 10 minutes followed by an infusion of 0.5 μg.kg-1.hr-1which will becombined with inhaled sevoflurane titrated to maintain an end-tidal concentration of 0.5 MAC. Anaestheticdepth will be titrated with the sevoflurane to ensure that the BIS value stays below 60 and above 40. Patients in Group P will be maintained on a propofol infusion based on the Eleveld-2.1 PKPD model targeting an effect site plasma concentration of 3 μg.ml-1. Anaesthetic depth will be adjusted by increasing or decreasing the effect site concentration of propofol by 0.5 μg.ml-1, in order to maintain the BIS below 60 and above 40.Motor evoked potential (MEP) monitoring with trans- cranial electrical stimulation of motor cortex with electrodes C3, C4 placed according to the international 10-20 EEG system. Stimulus will be applied at a strength of 300-500V, with train stimulus reserved for inability to elicit evoked potentials with a single twitch. Muscle relaxants will not be use intraoperatively during tcMEP recording and subsidence of action of atracurium will be ascertained by ensuring all four twitches on train-of-four, with absence of fade. For the purpose of our comparison, we will record the amplitude of cMAPs recorded from the all groups ofmuscles of the patients (side with the higher amplitude in baseline recording will be taken). cMAP baseline amplitude will be noted before the commencement of surgery and at time of dural opening / beginning of procedure. Variables noted will include: Reliability of the MEP recorded- proportion of muscles with recordable cMAPs to the total number of muscles monitored. We defined reliability of the MEP as a proportion of the muscles from which a measurable MEP signal / cMAP was achieved, to the total number of muscles for which measuring electrodes were placed, expressed as a percentage. Number of stimuli required to elicit recordable cMAP. Increase in stimulus strength (voltage). Episodes of MEP suppression- global or focal.
Any patient in whom the baseline MEP amplitude is less than 50 V after reasonable escalation of stimulation strength and frequency will be considered to have absent evoked potential. The anaesthetic team will then have the option to cross-over the anaesthetic technique to the alternative group and attempt to record the MEP.
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