| CTRI Number |
CTRI/2019/03/017893 [Registered on: 01/03/2019] Trial Registered Prospectively |
| Last Modified On: |
22/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparison of two drugs (Clonidine and Enalapril)given to reduce increase in blood pressure during insertion of tracheal tube intubation and while making patient prone positioning during spine surgeries |
|
Scientific Title of Study
|
A randomized double blinded comparative study of Intravenous Enalapril with Clonidine for stress attenuation during intubation and prone positioning in spine surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gayathri Ramanathan |
| Designation |
Professor |
| Affiliation |
SRM MCH RC CHENNAI |
| Address |
Department of Anesthesiology
Room No 209
seconfd floor
SRM Medical College Hospital
SRM Nagar
Kattankulathur
Chennai
603201
Kancheepuram
TAMIL NADU
6003203
India |
| Phone |
|
| Fax |
|
| Email |
gayathrii.r@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayathri Ramanathan |
| Designation |
Professor |
| Affiliation |
SRM MCH RC CHENNAI |
| Address |
Department of Anesthesiology
Room No 209
seconfd floor
SRM Medical College Hospital
SRM Nagar
Kattankulathur
Chennai
603201
Kancheepuram
TAMIL NADU
6003203
India |
| Phone |
|
| Fax |
|
| Email |
gayathrii.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meshach M Das |
| Designation |
Post graduate student |
| Affiliation |
SRM MCH RC CHENNAI |
| Address |
Department of Anesthesiology
Room No 209
second floor
SRM Medical College Hospital
SRM Nagar
Kattankulathur
Chennai
603201
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
|
| Fax |
|
| Email |
meshachmdhas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology
Room No 209
seconfd floor
SRM Medical College Hospital
SRM Nagar
Kattankulathur
Chennai
603203 |
|
|
Primary Sponsor
|
| Name |
SRM MCH RC CHENNAI |
| Address |
Department of Anesthesiology
Room No 209
seconfd floor
SRM Medical College Hospital
SRM Nagar
Kattankulathur
Chennai
603203 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Meshach M Dhas |
Department of Anesthesiology
Room No 209
seconfd floor
SRM Medical College Hospital
SRM Nagar
Kattankulathur
Chennai
603203 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gayathri |
SRM Medical College Hospital and Research Centre |
Department of Anesthesiology
Room No 209
seconfd floor
SRM Medical College Hospital
SRM Nagar
Kattankulathur
Chennai
603203
Kancheepuram
TAMIL NADU |
9500092905
gayathrii.r@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SRM Medical College Hospial and Research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M512||Other thoracic, thoracolumbar andlumbosacral intervertebral disc displacement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Clonidine 100microgram
|
Clonidine
Dose - 100 microgram
Route - Intravenous
Time period - Over 10 minutes
Frequency - Single injection |
| Intervention |
Injection Enalapril 1.25mg |
Enalapril
Dose - 1.25mg
Route - Intravenous
Time period - Over 10 minutes
Frequency - Single injection |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having problems in the spine (Lumbar and Thoracic)
Age 18 to 70 years
ASA 1 and 2
MPC 1 and 2
Willing to take part in the study |
|
| ExclusionCriteria |
| Details |
Patients who refuse the study
Patients with known allergies to the study drugs
Age >70 years
Diabetic patients with autonomic dysfunction
Hypertensive patients or those who on medications that influence blood pressure.
ASA III & IV, Mallampatti class III & IV
Emergency procedures
|
|
|
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 |
Heart rate and BP variability
|
During tracheal intubation
During postural change (Supine to prone positioning)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intra operative haemodynamics
Amount of intraoperative blood loss
Surgeon’s opinion on the surgical field
Aldrete score
Renal profile
|
Haemodynamics for the duration of surgery (every 5 minute ) till the end of surgery
Blood loss assessed at the end of surgery ( 10 minutes after completing the case)
Surgeons opinion at the end of surgery (10 minutes after completing the case)
Aldrete score immediately after extubation
Post operative renal profile |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
06/03/2019 |
| Date of Study Completion (India) |
23/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published in Indian journal of Anaesthesia |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients suffering from spine problems, who are posted for spine surgeries in prone position, ASA I with no anticipated difficulty in intubation will be selected for the study. These patients will be divided into two groups 1) Intervention group - These patients will be given Inj. Enalapril 1.25 milligram over 10 minutes 2) Comparator group - These patients will be given Inj. Clonidine 100 microgram over 10 minutes For both the groups, general anaesthesia will be given according to standardised anaesthetic technique Blood pressure and heart rate variability will be monitored during intubation and prone positioning Hemodynamic status will be monitored throughout the surgery Blood loss, Aldrete score and Surgeon’s opinion of the field will be assessed at the end of the surgery Postoperative renal profile will be noted |