| CTRI Number |
CTRI/2024/05/066764 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The effect of dexmedetomidine on the control of the brains blood flow in children, as assessed by doppler ultrasound of the blood vessels in the brain when under anaesthesia |
|
Scientific Title of Study
|
Assessment of the effect of dexmedetomidine on dynamic cerebral autoregulation in children assessed with transcranial doppler under sevoflurane anaesthesia undergoing spine surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mathew George |
| Designation |
Associate Professor |
| Affiliation |
Amrita Institute of Medical Sciences and Research Center, Kochi |
| Address |
Kodiyattil Kadungallur Rd
Thottakattukara PO
Aluva
7A2 Kent Hail Garden B
Stadium Link Road
Kaloor
Ernakulam
Kerala 682025
Ernakulam
KERALA
683108
India |
| Phone |
9447841795 |
| Fax |
|
| Email |
mathew.doc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mathew George |
| Designation |
Associate Professor |
| Affiliation |
Amrita Institute of Medical Sciences and Research Center, Kochi |
| Address |
Kodiyattil Kadungallur Rd
Thottakattukara PO
Aluva
7A2 Kent Hail Garden B
Stadium Link Road
Kaloor
Ernakulam
Kerala 682025
Ernakulam
KERALA
683108
India |
| Phone |
9447841795 |
| Fax |
|
| Email |
mathew.doc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhumita R |
| Designation |
MD Anaesthesia Resident |
| Affiliation |
Amrita Institute of Medical Sciences and Research Center, Kochi |
| Address |
2B NGO colony
6th Street Extension 2
Melagaram
Tenkasi
Tirunelveli
TAMIL NADU
627818
India |
| Phone |
8098944190 |
| Fax |
|
| Email |
madhumita0096@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences and Research Center, Kochi |
|
|
Primary Sponsor
|
| Name |
Dr Mathew George |
| Address |
Kodiyattil,
Thottakattukara P.O.,
Aluva, Ernakulam
Kerala 683108 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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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 and Research Center, Kochi |
Neurosurgical Operation theaters,
Amrita Institute of Medical Sciences and Research Center,
AIMS P.O.
Edapally,
Ernakulam
KERALA |
9447841795
mathew.doc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituttional Ethics Committee, Amrita Institute of Medical Sciences & Research Centre, Kochi |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q070||Arnold-Chiari syndrome, (2) ICD-10 Condition: Q062||Diastematomyelia, (3) ICD-10 Condition: M411||Juvenile and adolescent idiopathicscoliosis, (4) ICD-10 Condition: Q057||Lumbar spina bifida without hydrocephalus, (5) ICD-10 Condition: C720||Malignant neoplasm of spinal cord, (6) ICD-10 Condition: O||Medical and Surgical, (7) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, (8) ICD-10 Condition: M414||Neuromuscular scoliosis, (9) ICD-10 Condition: Q063||Other congenital cauda equina malformations, (10) ICD-10 Condition: M418||Other forms of scoliosis, (11) ICD-10 Condition: Q058||Sacral spina bifida without hydrocephalus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine infusion |
Following induction of anaesthesia with sevoflurane, the patient will receive an infusion of dexmedetomidine as described in the protocol. The transcranial doppler measurements will be taken following 10 minutes of test drug delivery by infusion and the study will conclude following the doppler measurements |
| Comparator Agent |
Saline |
Following induction of anaesthesia, the patient will receive an infusion of saline as described in the study protocol.The transcranial doppler measurements will be taken following 10 minutes of test drug delivery by infusion and the study will conclude following the doppler measurements |
|
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Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing spine surgery under Motor Evoked Potential monitoring |
|
| ExclusionCriteria |
| Details |
1)Age <3 months and >14years
2)Patients with known allergy to any of the drugs used in the study (general anaesthetics, dexmedetomidine)
3)Disturbed intracranial dynamics that may affect TCD readings –untreated hydrocephalus, craniosynostosis
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Transient Hyperaemic Response Ratio (THRR) measured from the right middle cerebral artery |
measurements of THRR will be made 10 minutues after induction of anaesthesia, before the commencement of the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Strength of Autoregulation(SA) will be calculated as a secondary outcome |
Measurements will be taken 10 minutes after the induction of anaesthesia, & before the commencement of surgery |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
18/05/2024 |
| 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="1"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Dexmedetomidine is a widely used anaesthetic adjunct and sedative agent, that has been touted to offer numerous benefits to both neurosurgical patients and children undergoing surgery. The transient hyperaemic response (THR) test is a simple, non-invasive technique to evaluate cerebral auto-regulation using transcranial doppler. The purpose of this study is to assess the effect of dexmedetomidine on cerebral autoregulation in children under anaesthesia using the THRR (Transient hyperaemic response ratio) in otherwise normal children undergoing spine surgery. We are planning to conduct the study on patients of <14 years of age, of ASA Grade I, II of either gender who are undergoing spine surgery We will exclude - 1)Age <3 months and >14years 2)Patients with known allergy to any of the drugs used in the study (general anaesthetics, dexmedetomidine) 3)Disturbed intracranial dynamics that may affect TCD readings –untreated hydrocephalus, craniosynostosis Patients randomly allotted to Group D or Group S based on computer generated random sequence of numbers Following a standardized induction of anaesthesia, they will be intubated and ventilated with sevoflurane at an end-tidal concentration of 1% or age adjusted 0.5% MAC in a 50% air-oxygen mixture and ventilated using volume control ventilation with a tidal volume of 8 ml/kg and a rate adjusted to an EtCO2 of 35 mm of Hg. The patient will receive the test drug according to the group they have been enrolled in.The syringe will be labelled as "Test Drug" and will be infused at a rate of (bodyweight *1.5) ml per hour. Patients enrolled in group D, the drug will be dexmedetomidine, while patients in group S the drug will be normal saline. Following the loading dose, TCD recordings will be taken (upto 3 sets). Transcranial doppler measurement of the right Middle Cerebral Artery M1 segment (rMCA) ill be insonated through the temporal bone window. Transcranial doppler measurements will be made using a portable RIMED Digi-One TCD system using a 2MHz probe After noting the baseline value of rMCA peak flow, the patient will be subjected to upto 3 compressions of the right carotid artery in the neck for 10 seconds, to produce a maximum decrease in the rMCA velocity, with at least 1 minute elapsing between each compression. The peak flow velocities of rMCA 1. before compression(F1), 2. during compression (F2), 3. immediately following release (F3)
will be noted and stored digitally as screenshots. Transient Hyperaemic Response Ratio=F3/F1 a value of more than 1.09 indicates intact autoregulation. Strength of Autoregulation (SA) : SA= (F3xP2)/(MAPxF1) P2 –denotes the MCA pressure at the beginning of compression, calculated as MAPxF2/F1 or taken as 60 mm of Hg. SA will be calculated only in patients in whom an arterial line is placed as indicated for patient management.
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