| CTRI Number |
CTRI/2021/08/035769 [Registered on: 18/08/2021] Trial Registered Prospectively |
| Last Modified On: |
15/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, dexmedetomidine , a drug used in tratment of raised blood pressure and for sedation and fentanyl, a drug used for pain relief and for sedation in patients undergoing spine surgery. |
|
Scientific Title of Study
|
A comparative study of the effect of dexmedetomidine and fentanyl on haemodynamic response in patients undergoing lumbar spine surgery under general anaesthesia - a randomized controlled study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh D R |
| Designation |
Junior resident |
| Affiliation |
Gajra raja medical college |
| Address |
Department of Anaesthesiology,
G.R. Medical college,
Gwalior
Gwalior
MADHYA PRADESH
474002
India |
| Phone |
9148157239 |
| Fax |
|
| Email |
rakeshdrajanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitendra Agrawal |
| Designation |
Associate professor |
| Affiliation |
Gajra raja medical college |
| Address |
Department of Anaesthesiology,
G.R. Medical college,
Gwalior
Gwalior
MADHYA PRADESH
474002
India |
| Phone |
9300009942 |
| Fax |
|
| Email |
drjagrawal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh D R |
| Designation |
Junior resident |
| Affiliation |
Gajra raja medical college |
| Address |
Department of Anaesthesiology,
G.R. Medical college,
Gwalior
Gwalior
MADHYA PRADESH
474002
India |
| Phone |
9148157239 |
| Fax |
|
| Email |
rakeshdrajanna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patients undergoing lumbar spine surgeries under general anesthesia at G. R. Medical College and J.A. Group of Hospitals |
|
|
Primary Sponsor
|
| Name |
Dr Rakesh D R |
| Address |
Department of Anaesthesiology,
G.R. Medical college,
Gwalior |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Jitendra Agrawal |
Associate Professor,
Department of Anaesthesiology,
G.R.Medical College, Gwalior
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakesh D R |
Jayarogya hospital |
Department of anaesthsiology ,jayarogya hospital,Gajra raja Medical college, gwalior
Gwalior
MADHYA PRADESH |
9148157239
rakeshdrajanna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee , Gajra Raja Medical college, gwalior |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Loading dose 0.5 µg /kg over 10 min before induction of anaesthesia and 0.25 µg / kg / hrs. infusion during intraoperative period |
| Comparator Agent |
Fentanyl |
Loading dose 1 µg/ kg over 10 min before induction of anaesthesia and 0.5 µg / kg / hrs. infusion during intraoperative period |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Consent to participate in study
2.American Society of Anaesthesiologist Grade I&II.
3.Patients undergoing lumbar spine surgeries under general anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1.Patients with disorder of cardiovascular, hepatic, renal or neuromuscular systems.
2.Patients with uncontrolled systemic diseases such as diabetes mellitus, hypertension, chronic obstructive lung disease9.
3.Patients on calcium channel blockers, beta blockers, chronic use of opioids.
•Patients with BMI>35.10
•Patients receiving drugs known to interact with study drugs.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dexmedetomide is more effective than fentanyl in maintaining heamodynamic changes during lumbar spine surgery under general anaesthesia |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Side effects and complications are minimal with both the drugs |
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
26/08/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective, double blinded, randomised controlled study comparing the effect of dexmedetomidine and fentanyl on haemodynamic response in patients undergoing lumbar spine surgery under general anaesthesia. Spinal surgery represent a challenge to the anaesthesiologist as they are accompanied with many perioperative problems which includes fluctuation in blood pressure and severe postoperative pain , in this study we are looking for better drug for attenuating this complications. |