| CTRI Number |
CTRI/2014/10/005148 [Registered on: 28/10/2014] Trial Registered Prospectively |
| Last Modified On: |
28/05/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Study to check the effect of drug called Dexmedetomidine on blood flow regulation to brain in patients having brain tumour |
|
Scientific Title of Study
|
Effect of Dexmedetomidine on cerebral blood flow auto-regulation 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 |
Sree Chitra tirunal institute for medical sccience and technology |
| Address |
Assistant professor, Neuroanesthesiology, Sri chitra tirunal institute for medical science and technology, medical college post, thiruvananthapuram
44, Avittom road residents association, kumarapuram, trivandrum, kerala.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9048842282 |
| Fax |
04712446433 |
| Email |
drarulvelan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MANIKANDAN S |
| Designation |
Additional professor |
| Affiliation |
Sree Chitra tirunal institute for medical sccience and technology |
| Address |
Additional professor, Neuroanesthesiology, Sri chitra tirunal institute for medical science and technology, medical college post, thiruvananthapuram
B-10, staff quarters, Sree chitra institute, kumarapuram, trivandrum, kerala
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9446334711 |
| Fax |
04712446433 |
| Email |
kanmanisethu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ARULVELAN |
| Designation |
Assistant professor |
| Affiliation |
Sree Chitra tirunal institute for medical sccience and technology |
| Address |
Assistant professor, Neuroanesthesiology, Sri chitra tirunal institute for medical science and technology, medical college post, thiruvananthapuram
44, Avittom road residents association, kumarapuram, trivandrum, kerala
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9048842282 |
| Fax |
04712446433 |
| Email |
drarulvelan@gmail.com |
|
|
Source of Monetary or Material Support
|
| SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCE AND TECHNOLOGY |
|
|
Primary Sponsor
|
| Name |
Sri Chitra Tirunal Institute for Medical Science and Technology |
| Address |
Sri Chitra Tirunal Institute for Medical science and Technology, medical college post, ulloor, thirvananthapuram. PIN 695011 |
| 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 |
Sri chitra tirunal institute for medical science and technology |
Room no 404, Department of anesthesiology, Neurosurgical complex, Sri chitra tirunal institute for medical science and technology, medical college post ulloor, thiruvananthapuram
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 |
neurologically stable patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Patients with glial neoplasm |
DEXMEDETOMIDINE will be given as infusion 1 microgram/kg over 10 minutes. (single dosage) |
| Comparator Agent |
patients with no pathology in brain |
DEXMEDETOMIDINE will be given as infusion - 1 microgram/Kg over 10 minutes. (single dosage) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
two groups (15 patients in each group)
Group I - patients with unilateral Glioma, Glascow coma scale 15, American society of anesthesiology Grading 1 and 2.
Group II - patients having no intracranial pathology ( patients posted for lumbar and thoracic spinal cord surgeries (laminectomy, discectomy), American society of anesthesiology Grading 1 and 2. |
|
| ExclusionCriteria |
| Details |
Patient refusal, American society of Anesthesiology (ASA) class 3 and above, Age less than 18 years and more than 35 years, Preoperative Glasgow coma scale (GCS) <15, Intracranial vascular abnormalities, Documented cases of Carotid stenosis, atherosclerosis, Infra tentorial / posterior fossa tumours, Emergency surgery, Preoperative heart rate <50 bpm, Systemic hypertension stage III & above, Heart block, Known allergy to Dexmedetomidine, Patient on beta blockers, Coronary artery disease, Left ventricular dysfunction,Pregnant or Nursing woman.
Antihypertensive medication with alpha-methyldopa, clonidine or other a2-adrenergic agonist, Vascular pathology ( Plaque, calcification, narrowing, stenosis, abnormal flow pattern ) identified during pre-induction sonography, Difficulty in localizing intracranial vasculature by TCCDI, Abnormal bone window, 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 |
| effect of dexmedetomidine on cerebral vascular autoregulation |
immediately after completion of Dexmedetomidine infusion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| cerebral hemodynamics, and cerebral vascular resistance |
immediately after infusion of Dexmedetomidine |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
03/11/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
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 HR, NIBP, SpO2, EtCO2 will be recorded. Ultrasound scan ( grey scale & Doppler ) of bilateral carotid arteries to rule out plaque, stenosis or other flow limiting lesions. Under Lignocaine (2%) skin infiltration I.V access and arterial access will be obtained. baseline analysis : · TCCDI analysis of Right and left Middle cerebral artery flow velocity · Baseline flow velocity for 5 seconds · Flow velocity Compression of Rt. Side carotid artery ( 3 sec ) · Flow velocity After release of compression for 5 seconds · infusion of Inj. Dexmedetomidine 1 mcg/Kg/ 10 min by infusion pump. Continuous Vital parameters monitoring 10 min ( HR/IBP/SpO2/EtCO2 ) Post dexmedetomidine analysis : Continuous Vital parameters monitoring ( HR/IBP/SpO2/EtCO2 ) · TCCDI analysis of Right and left MCA flow velocity · Baseline flow velocity for 5 seconds · Flow velocity Compression of Rt. Side carotid artery ( 3 sec ) · Flow velocity After release of compression for 5 seconds · After induction routine anaesthesia protocol will be employed. Data collection: manual entry into the study proforma. Observations: Baseline heart rate, Invasive blood pressure (sys/ dias/ mean), oxygen saturation before starting the anesthesia induction . Baseline recording of MCA flow velocity, pulsatility index & resistance index on both hemispheres using Transcranial colour Doppler imaging. Auto regulation assed by Transient hyperaemic response The hemodynamic variables (HR ,SBP,DBP and MAP) ,oxygen saturation, End tidal carbon dioxide (EtCO2) & respiratory rate during induction with Dexmedetomidine Heart rate, Invasive blood pressure (sys/ dias/ mean), oxygen saturation after induction with Dexmedetomidine. Recording of MCA flow velocity, pulsatility index & resistance index on both hemispheres using Transcranial colour Doppler imaging after induction with Dexmedetomidine. Auto regulation - Transient hyperaemic response after induction Any hemodynamic and respiratory adverse events such as hypotension, hypertension, Bradycardia, oxygen desaturation and other events will be recorded. |