| CTRI Number |
CTRI/2018/04/013065 [Registered on: 05/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
26/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
to compare dexmedetomidine versus nitroglycerine as a hypotensive agent causing less blood loss in posterior fixation surgery of spine. |
|
Scientific Title of Study
|
COMPARISON OF EFFICACY OF DEXMEDETOMIDINE VERSUS NITROGLYCERINE AS A HYPOTENSIVE AGENT IN PATIENTS UNDERGOING POSTERIOR FIXATION SURGERY OF SPINE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
chandrika priyadarshini |
| Designation |
first year PG resident |
| Affiliation |
VMMC AND SAFDARJUNG HOSPITAL,NEW DELHI |
| Address |
department of anaesthesia and critical care, VMMC AND SAFDARJUNG HOSPITAL,NEW DELHI
NEW DELHI
South
DELHI
110029
India |
| Phone |
8882123216 |
| Fax |
|
| Email |
mary.chandrika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JEETENDRA KUMAR BAJAJ |
| Designation |
Consultant and Professor |
| Affiliation |
VMMC AND SAFDARJUNG HOSPITAL,NEW DELHI |
| Address |
Department Of Anaesthesia and Intensive Care, Vardhaman Mahavir Medical College And Safdarjung Hospital, New Delhi.
South
DELHI
110029
India |
| Phone |
9810465070 |
| Fax |
|
| Email |
Jeetendrabajaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
chandrika priyadarshini |
| Designation |
first year PG resident |
| Affiliation |
VMMC AND SAFDARJUNG HOSPITAL,NEW DELHI |
| Address |
department of anaesthesia and critical care, VMMC AND SAFDARJUNG HOSPITAL,NEW DELHI
South
DELHI
110029
India |
| Phone |
8882123216 |
| Fax |
|
| Email |
mary.chandrika@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhaman Mahavir Medical College And Safdarjung Hospital, New Delhi 110029. |
|
|
Primary Sponsor
|
| Name |
Vardhaman Mahavir Medical College And Safdarjung Hospital |
| Address |
Department of Anaesthesia and critical care,ground floor,main ot building,new delhi 110029 |
| 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 |
| CHANDRIKA PRIYADARSHINI |
vmmc and safdurjung hospital,new delhi |
department of anaesthesia and crtical care,ground floor,main ot building.
South
DELHI |
8882123216
mary.chandrika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE,VMMC & SAFDARJUNG HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
age 18-65yrs ,ASA I and II, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dexmedetomidine |
After induction of general anaesthesia,Patients in the group A will be infused intravenously with a loading dose of dexmedetomidine 1mcg/kg diluted in 10ml of 0.9% normal saline over 10mins, followed by a maintenance infusion of dexmedetomidine at 0.2-0.7 mcg/kg/hr. Both bolus and infusion will be given by a syringe pump. |
| Comparator Agent |
nitroglycerine |
Patients in the group will receive an infusion with nitroglycerine drip (0.01%) at 3- 5 mcg/kg/min after induction of general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age 18-65yrs undergoing posterior fixation of spine surgery under general anaesthesia
2. ASA I and II
|
|
| ExclusionCriteria |
| Details |
1. Patients with hypertension
2. Patients with history of significant systemic disorders ( like cardiovascular, respiratory , central nervous system, hepatic and renal )
3. Patients with bleeding disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare intra-operative haemodynamic changes and blood loss with infusion of dexmedetomidine and nitroglycerine in patients undergoing posterior fixation surgery of spine. |
intra-operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the recovery characteristics and side effects of both these drugs in patients undergoing posterior fixation surgery of spine. |
intra-operative |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/12/2017 |
| 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="0" |
|
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
|
This
study is planned to compare dexmedetomidine with nitroglycerine as a hypotensive
agent during posterior fixation surgery of spine in terms of (1)intraoperative haemodynamic changes and blood loss (2)the recovery characteristics and side effects . HYPOTHESIS-Dexmedetomidine
is superior than nitroglycerine as a hypotensive agent in patients undergoing
posterior fixation surgery of spine. |