| CTRI Number |
CTRI/2016/02/006680 [Registered on: 25/02/2016] Trial Registered Retrospectively |
| Last Modified On: |
17/05/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
This is a study to check the effect of blood flow to the brain after increase in blood pressure when using a drug called Dexmedetomidine in patients with brain tumours. |
|
Scientific Title of Study
|
Effect of Dexmedetomidine infusion on static autoregulation of cerebral blood flow in patients with intracranial tumours |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ARULVELAN |
| Designation |
Assistant professor |
| Affiliation |
Sri Chitra Tirunal Institute for Medical Science and Technology |
| Address |
Room No 604, Fourth floor, Department of Anesthesiology, Sri Chitra Tirunal Institute for Medical Science and Technology, Medical college post, Ulloor, Thiruvananthapuram, Kerala
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9048842282 |
| Fax |
|
| Email |
drarulvelan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ARULVELAN |
| Designation |
Assistant professor |
| Affiliation |
Sri Chitra Tirunal Institute for Medical Science and Technology |
| Address |
Room No 604, Fourth floor, Department of Anesthesiology, Sri Chitra Tirunal Institute for Medical Science and Technology, Medical college post, Ulloor, Thiruvananthapuram, Kerala
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9048842282 |
| Fax |
|
| Email |
drarulvelan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ARULVELAN |
| Designation |
Assistant professor |
| Affiliation |
Sri Chitra Tirunal Institute for Medical Science and Technology |
| Address |
Room No 604, Fourth floor, Department of Anesthesiology, Sri Chitra Tirunal Institute for Medical Science and Technology, Medical college post, Ulloor, Thiruvananthapuram, Kerala
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9048842282 |
| Fax |
|
| Email |
drarulvelan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Chitra Tirunal Institute for Medical Science and Technology, Medical college post, Ulloor, Thiruvananthapuram, Kerala, PIN:695011, INDIA. |
|
|
Primary Sponsor
|
| Name |
Sri Chitra Tirunal Institute for Medical Science and Technology |
| Address |
Medical college post, Ulloor, Thiruvananthapuram, Kerala, PIN: 695011, INDIA |
| 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 |
| Arulvelan |
Room No:600, Neuro OT complex, Fourth floor, Department of Anaesthesiology |
Room No 600, Neuro OT complex, Fourth floor, Department of Anesthesiology, Sri Chitra Tirunal Institute for Medical Science and Technology, Medical college post, Ulloor, Thiruvananthapuram, Kerala
Thiruvananthapuram
KERALA |
9048842282
drarulvelan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients with intracranial tumour and patients posted for spinal cord procedures (no intracranial pathology), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine |
Dexmedetomidine (1 microgram/Kg) will be given over 10 minutes to patients with intracranial tumours and static autoregulation will be assessed |
| Intervention |
Dexmedetomidine |
Dexmedetomidine (1 microgram/Kg) will be given over 10 minutes to patients without intracranial tumours ( spine surgeries) and static autoregulation will be assessed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Two groups of patients will be included (10 patients in each group)
• Group I – patient with unilateral supra tentorial tumours
• Group II – patients with no intra cranial pathology (lumbar spinal cord procedures)
Inclusion criteria:
•Patients categorized as American society of Anesthesiology (ASA) class 1 and 2.
•Age 18-40 years.
•Glasgow coma scale 15.
•patients with unilateral tumour in supratentorial compartment like glioma and meningioma (GroupI)
•Patients posted for lumbar spinal cord procedures including laminectomy, discectomy and spinal cord tumour excision (Group II)
|
|
| ExclusionCriteria |
| Details |
• Patient refusal
• American society of Anesthesiology (ASA) class III and above
• Age less than 18 years and more than 40 years.
• Emergency surgery
• Presence of intracranial vascular abnormalities ( Aneurysm, Arterio venous malformation)
• Known allergy to Dexmedetomidine or any α2 agonists.
• Known allergy to Inj. Phenylephrine
• Preoperative heart rate <50 bpm, Presence of Heart block.
• Systemic hypertension stage III & above
• Antihypertensive medication with α-methyldopa or Clonidine.
• Patient on beta blockers
• Presence of Coronary artery disease, Left ventricular dysfunction,
• Pregnant or Nursing woman.
• Abnormal temporal bone window for transcranial Doppler insonation
• Difficulty in localizing intracranial vasculature by Transcranial color Doppler
• Participation in another drug study during the preceding 1 month period.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| static cerebral vascular autoregulation |
1. Baseline and
2.After administration of Dexmedetomidine (10 minutes after baseline) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mean flow velocity of middle cerebral artery and Pulsatility index, cerebral perfusion pressure derived from flow velocity data. |
1. baseline
2.after dexmedetomine (1mcg/kg over 10 minutes) |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
23/06/2014 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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)?
|
|
Brief Summary
|
Cerebral
autoregulation is the intrinsic ability of the brain to maintain stable cerebral
blood flow while mean arterial blood pressure and cerebral perfusion pressure
are changing. It constitutes a regulatory mechanism to provide metabolic
substrates under physiological and pathological conditions.
Impaired
autoregulation is demonstrated in the scenario of decreased perfusion pressure
with the use of inj. Dexmedetomidine (dynamic autoregulation). On the other
hand when there is increase in perfusion pressure preliminary studies showed
that autoregulation is maintained but the clinical and statistical significance
was not discussed (static autoregulation).
Thus our study is designed to assess the effect
of initial dose Dexmedetomidine (1mcg/Kg over 10 minutes) in static cerebral blood
flow autoregulation. Infusion of Inj.Phenylephrine (0.01%) will be used and cerebral
blood flow velocities will be measured with the use of transcranial Doppler. As there is scarcity of data on this phenomenon especially in patients with intracranial pathology, this study is designed to address this issue in patients with intracranial tumours.
Proposed
study protocol:
·
Informed
consent will be taken from Patients satisfying inclusion criteria. Consenting
patients will be included in the study protocol.
·
Patient
will be shifted in to operating room. Monitors will be attached and baseline
Heart rate(HR), non invasive blood pressure(BP), respiratory rate (RR), SpO2,
End tidal Carbon dioxide (EtCO2) will be
recorded.
·
Bilateral
Transcranial colour Doppler imaging to ensure adequate temporal bone window and
adequate insonation of middle cerebral arteries.
·
Under
Lignocaine (2%) skin infiltration I.V access and arterial access will be
obtained.
·
Inj.Glycopyrrolate
0.2mg will be given by intravenous route.
Baseline
analysis :
·
Right
and left Middle cerebral artery (MCA) flow velocities will be recorded with
Transcranial colour Doppler twice with 1 minute interval (Right MCA, Left MCA →
1 minute → Right MCA, Left MCA).
·
Mean
arterial pressure will be increased gradually by 20mmHg with infusion of
Inj.Phenylephrine (0.01%). After achieving steady state of blood pressure,
infusion will be stopped.
·
Transcranial
Doppler analysis of Right MCA and Left MCA flow velocities after steady state increase
in blood pressure (Right MCA, Left MCA → 1 minute → Right MCA, Left MCA).
Inj.Dexmedetomidine
will be given as infusion (1mcg/Kg/10 min) by infusion pump.
Vital parameters (HR/IBP/RR/SpO2/EtCO2)
will be monitored continuously during administration of Inj.Dexmedetomidine.
Analysis
after administration of Dexmedetomidine :
·
Vital
parameters monitoring ( HR/IBP/RR/SpO2/EtCO2 ) will be continued.
·
Right
and left Middle cerebral artery (MCA) flow velocities will be recorded with
Transcranial colour Doppler twice with 1 minute interval (Right MCA, Left MCA →
1 minute → Right MCA, Left MCA).
·
Mean
arterial pressure will be increased gradually by 20mmHg with infusion of
Inj.Phenylephrine (0.01%). After
achieving steady state of blood pressure, infusion will be stopped.
·
Transcranial
Doppler analysis of Right MCA and Left MCA flow velocities after steady state
increase in blood pressure (Right MCA, Left MCA → 1 minute → Right MCA, Left
MCA).
After study period Inj.
Dexmedetomidine will be continued introperatively in the dose of 0.4 to 0.6
mcg/Kg/Hour as an adjuvant to anaesthetic agents.
Average flow velocity
of MCA will be calculated from the repeated measurements and used for analysis.
Static rate of
autoregulation (sROR) will be calculated during baseline and after infusion of
Inj.Dexmedetomidien (1mcg/Kg /10min).
sROR = ([i]Vmca/[f]Vmca -
[i]MABP/[f]MABP) / (1- [i]MABP/[f]MABP) X 100%.
[i] Vmca- baseline MCA flow velocity
[f] Vmca - MCA flow velocity after mean blood
pressure increase of 20mmHg
[i] MABP - baseline Mean arterial blood pressure
before Inj.Phenylephrine.
[f] MABP - Mean arterial blood pressure after steady
state ( 20mmHg increase)
An sROR of 100%
implies perfect autoregulation and 0% implies absent autoregulation. For
clinical application less than 50% or a
decreasing trend towards 0% signifies
impaired autoregulation. |