| CTRI Number |
CTRI/2018/03/012556 [Registered on: 15/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
12/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of nasal and venous dexmetomidine on change of blood pressure and heart rate during anaesthesia in lumber spine surgery |
|
Scientific Title of Study
|
Comparative Study Between Intranasal and Intravenous Dexmedetomidine As A Premedication To Attenuate Hemodynamic Response To Laryngoscopy And Endotracheal Intubation In Elective Lumbar Spine Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asit Biswas |
| Designation |
postgraduate trainee |
| Affiliation |
IPGMER |
| Address |
Bangur Institute of Neurosciences,Debendra Lal Khan Road, S S K M Hospital, Bhawanipur, Kolkata,
Kolkata
WEST BENGAL
700020
India |
| Phone |
|
| Fax |
|
| Email |
asit.rgkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saikat Niyogi |
| Designation |
Associate Professor |
| Affiliation |
IPGMER |
| Address |
Bangur Institute of Neurosciences, anaesthesia department,Debendra Lal Khan Road, S S K M Hospital, Bhawanipur, Kolkata,
Kolkata
WEST BENGAL
700020
India |
| Phone |
|
| Fax |
|
| Email |
saikatneuro1972@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saikat Niyogi |
| Designation |
Associate Professor |
| Affiliation |
IPGMER |
| Address |
Bangur Institute of Neurosciences,Debendra Lal Khan Road, S S K M Hospital, Bhawanipur, Kolkata,
Kolkata
WEST BENGAL
700020
India |
| Phone |
|
| Fax |
|
| Email |
saikatneuro1972@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangur Institute of Neurosciences,Debendra Lal Khan Road, S S K M Hospital, Bhawanipur, Kolkata 700020,West Bengal. |
|
|
Primary Sponsor
|
| Name |
Bangur Institute of Neurosciences |
| Address |
Debendra Lal Khan Road, S S K M Hospital, Bhawanipur, Kolkata, West Bengal |
| Type of Sponsor |
Government 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 |
| SAIKAT NIYOGI |
Bangur Institute of Neurosciences,Anaesthesia department |
Anaesthesia department,Debendra Lal Khan Road, S S K M Hospital, Bhawanipur, Kolkata 700020
Kolkata
WEST BENGAL |
9831732443
saikatneuro1972@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER INSTITUTIOAL ETHECAL COMMITE ,IPGMER, KOLKATA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
elective lumber spine surgery. , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intranasal dexmedetomidine |
intranasal dexmedetomidine at a dose of 1 mcg/kg body weight along with IV 0.9% normal saline infuse over 45 minutes before induction |
| Comparator Agent |
intravenous dexmedetomidine |
intravenous dexmedetomidine at 0.75µg/kg in 50 ml Normal Saline. and infuse over 45 minutes before induction along with intranasal 0.9% normal saline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with ASA physical status I and II.
2)Patients having Mallampati I and II
3)Patients in the age group between 18 to 60 years of age
4)Patients with body mass index (BMI) < 30 kg/m2
5)Patients of either sex
6)Patients posted for elective lumber spine surgery under general anaesthesia
|
|
| ExclusionCriteria |
| Details |
1)Patients refusal to participate in the study
2)Known allergy or hypersensitive reaction to dexmedetommidine.
3)Patients suffering from significant cardiac disease e.g. IHD, cardiomyopathy, valvular disorder, hypertension, arrhythmia, etc.
4)Patients suffering from significant respiratory disease e.g. COPD, bronchial asthma, interstitial lung diseases, pneumonia etc.
• Patients having metabolic, endocrinal, musculoskeletal, neurologic disorder or having major congenital anomalies.
• History of drug abuse and/or psychiatric disorder
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean arterial pressure (MAP) |
Mean arterial pressure (MAP) at baseline then every 10 min intervals from intranasal dexmedetomidine administration in preinduction period, during induction, after intubation, every 1 min interval till 5mins and at 7 min and 10 min after intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
heart rate (HR), , respiratory rate (RR) and oxygen saturation (spO2)
Baseline sedation status will be assessed by an observer using theRamsay sedation scale
any other side effect |
at baseline then every 10 min intervals from intranasal dexmedetomidine administration in preinduction period, during induction, after intubation, every 1 min interval till 5mins and at 7 min and 10 min after intubation.
Baseline sedation status will be assessed by an observer using theRamsay sedation scale before induction |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3 |
|
Date of First Enrollment (India)
|
01/07/2017 |
| 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="6"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1.
Laryngoscopy and
tracheal intubation violate the patient’s airway reflexes and predictably lead
to hypertention and tachecardia.Dexmedetomidine is a potent, highly selective
and specific alpha2 agonist that has both sedative and analgesic effects with
minimal respiratory depression. Various methods of drug delivery are
oral,rectal, intravenous, intramuscular ,but intranasal route is advantageous
in that it is easy to use, painless, odourless,tasteless, well tolerated,
avoids first pass metabolism with more haemodynamic stability1
2.
Methodology:A prospective randomized double
blind study will be carried out on 70( ASA-1andII)patients, aged 18-60
years,scheduled for elective lumbar spine surgery under general
anaesthesia.Group -DIN,patients will receive intranasal
dexmedetomidine1 mcg/kg andGroupDI.V will
receive intravenous Dexmedetomidine at
0.75µg/kg before induction.Hemodynamic response will be monitored in every 10 min intervals
from drug administration to
induction, immediatelyafter intubation, then
every 1 min interval till 5mins and at 7 min and 10 min after
intubation.
3.
Expected outcome :The primary expected
outcome from the study that whether the effect of intranasal Dexmedetomidine is superior,equivalent or
inferior to that of intravenous Dexmedetomidine during laryngoscopy and
intubation.
|